Restricted list final_2010

WHO/EMP/QSM/2010.3

PHARMACEUTICALS:
RESTRICTIONS IN USE
AND AVAILABILITY

PHARMACEUTICALS:
RESTRICTIONS IN USE AND AVAILABILITY

Prepared within the context of the United Nations publication

"Consolidated List of Products whose Consumption and/or Sale
have been Banned, Withdrawn, Severely Restricted or Not
Approved by Governments"

Update of the Fourteenth Issue

2010

Essential Medicines and Pharmaceutical Policies
Quality Assurance and Safety: Medicines
Health Systems and Services

© World Health Organization 2010

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Acknowledgements:

WHO expresses its sincere appreciation to the National Pharmacovigilance Centres and / or National Medicines
Regulatory Agencies, for providing the information contained in this publication. Sincere thanks are due to
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University of Maryland-Baltimore, USA for their assistance with content editing, layout and technical support.

INTRODUCTION iii

This text is the update to the Fourteenth Issue of the United Nations Consolidated List of Products whose
Consumption and/or Sale have been Banned, Withdrawn, Severely Restricted or Not Approved by
Governments - Pharmaceuticals (UN General Assembly Resolutions 37/137, 1982; 38/149, 1983; 39/229,
1984; 44/226, 1989). It is offered as a service to drug regulators, the pharmaceutical industry, and to
everyone interested in assuring the safe and rational use of drugs. It complements and consolidates
other drug-related information issued by the World Health Organization, including the WHO Rapid Alerts,
WHO Pharmaceuticals Newsletter and the quarterly subscription journal WHO Drug Information.

Scope and presentation

This volume presents information on new national regulatory decisions and on voluntary withdrawal of
products by manufacturers on grounds of safety from 2009, 2010 (up to May 2010), and earlier years that
had not been included in the last update.

Products are listed alphabetically within sections; International Nonproprietary Names (INNs) have been
used whenever possible. Each product entry includes, where available, the Chemical Abstracts Service
registry number (CAS number); synonyms including other generic names and chemical names; the
effective date on which the regulation came into force; a summary of regulatory measures taken by
governments; brief explanatory comments where necessary; and legal and bibliographical references.

While the information cannot be regarded as exhaustive, either in terms of products or regulatory
measures, it covers regulatory actions taken by a total of 38 governments on 99 products. It should be
noted, nonetheless, that decisions taken by a limited number of governments on a specific product may
not be representative of the positions of other governments. Moreover, the fact that a given product is not
listed as regulated by a country does not necessarily mean that it is permitted in that country; it may mean
that the relevant regulatory decision has not been communicated to WHO or that the product has not
been submitted for registration. The efficacy of products listed is not addressed, but is an aspect that may
be crucial when a government is considering regulatory action.

Criteria for the inclusion of products in the Consolidated List were developed in 1985 and revised in the
light of the comments received from governments. However, governments' interpretation of the criterion
"severely restricted", in particular, continues to vary widely, leading to considerable unevenness in
reporting. When necessary, additional information and/or clarification have been requested from
governments; products which clearly do not meet the criteria have been omitted after consultation with
governments. Information received from non-governmental organizations has, in each case, been
verified with governments.

The information provided also includes references to relevant legal or statutory documents that enable
the user to ascertain the legal context and scope of the regulations. Such references cannot be given for
most entries relating to specific pharmaceutical products since the relevant licenses are often made or
amended by an administrative decision which is not published. Brief explanatory comments also appear,
where necessary, to clarify certain regulatory actions and put them into broader context.

iv ALPHABETICAL LISTING OF PRODUCTS

Table of Contents

Alphabetical listing

Monocomponent Products

Aliskiren........................................................................................................................... 1
Aprotinin .......................................................................................................................... 1
Becaplermin .................................................................................................................... 2
Benzyl alcohol ................................................................................................................. 2
Bufexamac ...................................................................................................................... 3
Cabergoline..................................................................................................................... 3
Carbinoxamine ................................................................................................................ 4
Ceftriaxone...................................................................................................................... 4
Chloroquine..................................................................................................................... 5
Chromic-phosphate-P-32 ................................................................................................ 6
Clindamycin..................................................................................................................... 6
Clopidogrel ...................................................................................................................... 6
Clozapine ........................................................................................................................ 7
Colchicine........................................................................................................................ 8
Cyproterone .................................................................................................................... 9
Deferasirox...................................................................................................................... 9
Desmopressin ............................................................................................................... 10
Dextropropoxyphene ..................................................................................................... 10
Efalizumab .................................................................................................................... 11
Etoricoxib ...................................................................................................................... 13
Etravirine ....................................................................................................................... 13
Fentanyl ........................................................................................................................ 13
Flecainide...................................................................................................................... 14
Gadolinium .................................................................................................................... 14
Gadoversetamide .......................................................................................................... 15
Goserelin....................................................................................................................... 15
Human Chorionic Gonadotropin Hormone .................................................................... 16
Human immune globulin................................................................................................ 16
Iron sucrose .................................................................................................................. 17
Isotretinoin..................................................................................................................... 17
Ivermectin...................................................................................................................... 18
Ketoprofen..................................................................................................................... 18
Laronidase .................................................................................................................... 19
Letrozole ....................................................................................................................... 19
Mefenamic acid ............................................................................................................. 19
Mefloquine..................................................................................................................... 20
Metamizole.................................................................................................................... 20
Methylphenidate ............................................................................................................ 20

ALPHABETICAL LISTING OF PRODUCTS v

Methylthioninium chloride.............................................................................................. 21
Metoclopramide............................................................................................................. 21
Misoprostol.................................................................................................................... 22
Moxifloxacin .................................................................................................................. 22
Mycophenolate mofetil .................................................................................................. 22
Nifuroxazine .................................................................................................................. 23
Nimesulide .................................................................................................................... 23
Nitrous oxide ................................................................................................................. 25
Norfloxacin .................................................................................................................... 26
Orciprenaline................................................................................................................. 26
Pergolide ....................................................................................................................... 26
Phenazone .................................................................................................................... 27
Phenylpropanolamine.................................................................................................... 27
Pimecrolimus................................................................................................................. 28
Piroxicam ...................................................................................................................... 28
Promethazine ................................................................................................................ 28
Propylthiouracil.............................................................................................................. 29
Pseudoephedrine .......................................................................................................... 29
Rimonabant................................................................................................................... 30
Sibutramine ................................................................................................................... 30
Sodium phosphate ........................................................................................................ 32
Stichopus sp. (S. horrens, S. variegatus) ...................................................................... 33
Tacrolimus..................................................................................................................... 33
Telithromycin................................................................................................................. 34
Thalidomide................................................................................................................... 34
Tibolone ........................................................................................................................ 35
Tinzaparin ..................................................................................................................... 35
Tiotropium ..................................................................................................................... 36
Toremifene .................................................................................................................... 36
Tramadol ....................................................................................................................... 37
Triamcinolone................................................................................................................ 37
Vincristine...................................................................................................................... 37
Zinc-containing intranasal products............................................................................... 38

Combination Products

Baithach ........................................................................................................................ 39
Belly cut capsules ......................................................................................................... 39
Chloral hydrate and triclofos.......................................................................................... 39
Chloroproguanil and dapsone ....................................................................................... 40
Clindamycin and miconazole......................................................................................... 40
Dietary supplements...................................................................................................... 41
Dismectide .................................................................................................................... 41
Ephedrine and kava kava products ............................................................................... 41
Levonorgestrel + Intra-uterine Contraceptive Devices (IUCDs)..................................... 42
Neomycin sulphate, polymyxine sulphate and nystatin ................................................. 42

vi ALPHABETICAL LISTING OF PRODUCTS

Paracetamol and pseudoephedrine .............................................................................. 43
Rhinoil ........................................................................................................................... 43
Tadimax ........................................................................................................................ 43
Vitrum Beauty Elite........................................................................................................ 44

Group Products

Angiotensin converting enzyme inhibitors and angiotensin II receptor antagonists....... 45
Nasal sprays ................................................................................................................. 45
Codeine and dihydrocodeine-containing medicines ...................................................... 46
Cough and cold medicines ............................................................................................ 46
Ergot-derived dopamine agonists.................................................................................. 48
Erythropoiesis-stimulating agents ................................................................................. 49
Herbal cold and flu products.......................................................................................... 49
Inhalers with CFC propellants ....................................................................................... 50
Long-acting beta-agonists ............................................................................................. 50
Oral preparations containing alcohol ............................................................................. 51
Salicylates ..................................................................................................................... 51
Short acting beta-agonists (SABAs) .............................................................................. 51
Vitamins ........................................................................................................................ 52

MONOCOMPONENT PRODUCTS 1

Product Name: Aliskiren
CAS Number: 173334-57-1
Other Names: Tekturna, Rasilezt
Country Effective Description of action taken
Date Grounds for decision
European Union 2009 The European Medicines Agency (EMA) has added
contraindication to the Product Information for aliskiren, which
states that it is not to be used in patients who have
experienced angioedema when taking aliskiren in the past.
The Agency has also recommended that patients who
develop signs of angioedema should stop treatment and seek
medical attention.

Reference:
1. Press Release, EMA, 19 Feb 2009 (www.ema.euopa.eu).
2. WHO Pharmaceuticals Newsletter No. 2, 2009.

UK 2009 The Medicines and Healthcare products Regulatory Agency
(MHRA) has warned about the risk of angioedema and renal
dysfuntion with the use of aliskiren and the risk associated
with the concomitant use of aliskiren and non-steroidal anti-
inflammatory drugs (NSAIDs). Aliskiren treatment may lead to
renal insufficiency and acute renal failure in patients with
renal artery stenosis. Concomitant use of NSAIDs may reduce
the antihypertensive effect of aliskiren, which may result in
further deterioration of renal function, including possible acute
renal failure, which is usually reversible when treatment is
stopped. Health-care professionals are advised not to use
aliskiren in patients who have previously had angioedema
after using it.

Reference:
1. Drug Safety Update, MHRA, Volume 2, Issue 10, May 2009
(www.mhra.gov.uk).

Product Name: Aprotinin
CAS Number: 9087-70-1
Other Names: Trasylol
Chile November In Chile, products with aprotinin injectable were withdrawn
2007 from the market in November 2007 due to the increased risk
of death compared to tranexamic acid and aminocaproic acid.

Reference:
Communication from the Chile National Pharmacovigilance

2 MONOCOMPONENT PRODUCTS

Centre, February 2008.

Singapore August 2008 In Singapore, the sales of aprotinin was temporarily
suspended as of 7 November 2007 due to the increased
mortality rate when compared to the epsolon-aminocaproic
acid or tranexamic acid. Currently, the drug manufacturer is
allowed to supply aprotinin when physicians deem there are
no therapeutic alternatives and its benefits outweigh its risks.
Physicians are required to undertake in writing that they will
inform patients of the risks of using aprotinin and patients'
signed consent is required.

Reference:
Communication from the Singapore National
Pharmacovigilance Centre, August 2008.

Product Name: Becaplermin
CAS Number: 165101-51-9
Other Names: Regranex
European Union 2010 The EMA has recommended contraindication for becaplermin
in patients with any pre-existing cancer, following a review of
the available data at the Agency’s Committee for Medicinal
Products for Human Use (CHMP) on a possible risk of cancer
associated with becaplermin use.

Reference:
1. Press Release, Questions & Answers, EMA, 18 Feb 2010
(www.ema.europa.eu).

Product Name: Benzyl alcohol
Other Names: Ulesfia, Zilactin-L
Iraq July 2008 All intravenous injection preparations for infants containing
benzyl alcohol have been banned.

Reference:
Communication from the Iraq National Pharmacovigilance
Centre, May 2010.


Product Name: Bufexamac
Other Names: Parfenac
European Union 22 April 2010 The EMA’s CHMP has recommended that marketing
authorizations for bufexamac-containing medicines be
revoked throughout the European Union (EU). The risk of
developing a contact allergic reaction to bufexamac is high,
and the risk is even higher in patients with pre-disposing
conditions, such as certain forms of eczema, for which
bufexamac is frequently prescribed.

Reference:
1. Press release, Questions and Answers, EMA,
22 April 2010 (www.ema.europa.eu).
2. WHO Pharmaceuticals Newsletter No.3, 2010.

Product Name: Cabergoline
Other Names: Cabaser
Switzerland 3 December The maximal daily dose of cabergoline has been restricted
2008 (reduced to 3 mg from 4 and 6 mg, respectively; tablets with
4 mg are not marketed any more by 31 December 2008 ) due
to known risk of cardiac valvulopathy. Additionally, a
cardiovascular examination prior to treatment has become
mandatory.

Reference:
Communication from Swissmedic, April 2010.


Product Name: Carbinoxamine
Other Names: Cristin, Palgic
Iraq April 2008 Carbinoxamine has been banned because of high incidence
of adverse drug reactions (ADRs) at therapeutic levels.

Reference:
Centre, May 2010.

Product Name: Ceftriaxone
Other Names: Rocephin
Canada 2008 The antibiotic ceftriaxone should not be mixed or co-
administered with calcium-containing solutions. Health
Canada issued the warning to hospitals after cases of fatal
reactions in neonates and infants were reported. The Agency
also advised that for patients aged less than 10 weeks,
intravenous ceftriaxone and calcium-containing solutions
should not be administered within five days of each other.

Reference:
1. Health Canada, 31 July 2008 (www.hc-sc.gc.ca).

Malaysia December Updates to the previous warning on potential interaction with
2009 calcium-containing intravenous solutions were incorporated in
the package insert as follows.
- Ceftriaxone is contraindicated in neonates (≤ 28 days of
age) if they require treatment with calcium-containing
intravenous solutions because of the risk of ceftriaxone-
calcium precipitation.
- In patients other than neonates, ceftriaxone and calcium-
containing solutions may be administered sequentially if the
infusion lines are thoroughly flushed between infusions with a
compatible fluid.
- Diluents containing calcium are not to be used to
reconstitute ceftriaxone vials or to further dilute a
reconstituted vial for intravenous administration because a
precipitate can form. Ceftriaxone must not be administered
simultaneously with calcium-containing intravenous solutions


because precipitation of can occur.

Reference:
1. Information for Healthcare Professionals: Ceftriaxone
(marketed as Rocephin and generics), FDA MedWatch,
2008 (www.fda.gov),.
2. Updated prescribing information for all ceftriaxone
products marketed in Canada, Health Canada,
2008 (www.hc-sc.gc.ca).

USA 2009 Based on studies, the U.S. Food and Drug Administration (US
FDA) has recommended the following:
- Concomitant use of ceftriaxone and intravenous calcium-
containing products is contraindicated in neonates (28 days of
age and under).
- Ceftriaxone should not be used in neonates (28 days of age
and under) if they are receiving (or are expected to receive)
calcium-containing products.
- In patients aged over 28 days, ceftriaxone and calcium-
containing products may be administered sequentially,
provided the infusion lines are thoroughly flushed between
infusions with a compatiblefluid.
- Ceftriaxone must not be administered simultaneously with
intravenous calcium-containing solutions via a Y-site in any
age group.
- Ceftriaxone and calcium-containing products may be used
concomitantly in patients aged over 28 days, using the
precautionary steps above because the risk of precipitation is
low in this population.

Reference:
1. Information for Healthcare Professionals, US FDA,
21 April 2009 (www.fda.gov).

Product Name: Chloroquine
CAS Number: 54-05-7
Other Names: Cloquine
Guinea-Bissau October 2008 From October 2008, tablets and syrup containing chloroquine
have been withdrawn in Guinea-Bissau. Coartem
(combination of artemether and lumefantrine) has replaced
chloroquine.

Reference:


Communication from the Guinea-Bissau National
Pharmacovigilance Centre, October 2010.

Product Name: Chromic-phosphate-P-32
Other Names: Phosphocol P 32, Phosphorus-32
USA 2008 Chromic-phosphate-P-32 suspension (Phosphocol P 32) use
may increase the risk of leukaemia after receiving intra-
articular Phosphocol P 32 injections. This route of
administration is not approved by the US FDA.
The Phosphocol P 32 package insert now contains a
Warnings statement with above information, and an Adverse
Reactions statement that reports that leukaemia in children
has been identified during postmarketing experience. An
additional Adverse Reactions statement highlights that
radiation injury to the bladder, caecum and small bowel
following Phosphocol P 32 administration into the peritoneal
cavity has also been identified.

Reference:
1. Dear Health-care Provider letter from Covidien,
Mallinckrodt Inc., 29 August 2008 (www.fda.gov).
2. WHO Pharmaceuticals Newsletters No. 5 & No. 6, 2008.

Product Name: Clindamycin
Other Names: Cleocin
Iraq April 2009 Clindamycin injection 150 mg has been added to the health
care list of restricted medicines and is to be used only for
patients with penicillin allergy.

Reference:
Centre, May 2010.

Product Name: Clopidogrel
CAS Number: 113665-84-2
Other Names: Plavix


European Union 2009 The EMA recommended updating the existing warning over
the concomitant use of clopidogrel-containing medicines and
proton-pump inhibitors (PPIs). In May 2009, the Agency’s
CHMP recommended that the product information for all
clopidogrel-containing medicines be amended to discourage
the concomitant use of PPIs and clopidogrel unless absolutely
necessary.

Reference:
1. Public statement, EMA, 17 March 2010

Malaysia July 2009 Updates in the package insert to inform that patients with
genetically reduced CYP2C19 function have lower systemic
exposure to the active metabolite of clopidogrel and
diminished antiplatelet responses, and generally exhibit
higher cardiovascular event rates following myocardial
infarction. Also, concomitant use of drugs that inhibit
CYP2C19 (e.g. proton pump inhibitors) should be
discouraged.

Reference:
Communication from the Malaysia National
Pharmcacovigilance Centre, May 2010.

New Zealand 2009 The New Zealand Medicines and Medical Devices Safety
Authority (Medsafe) have required the clopidogrel data sheets
to be updated, to include information about genetic factors
influencing clopidogrel metabolism, specifically in patients
with genetically reduced CYP2C19 function. The information
discouraging the use of concomitant medicines that inhibit
CYP2C19 metabolism, e.g. omeprazole, will also be included
as a precaution.

Reference:
1. Prescriber Update Volume 30, No. 3, August 2009
(www.medsafe.govt.nz).

Product Name: Clozapine
Other Names: Leponex
France 2010 - The initial prescription of the product should be made
annually at hospital (at the initiation of the treatment by


clozapine, and every year).
- The prescription and the renewal of the prescription (every
month) should be made by specialists in geriatry, neurology or
psychiatry.
- A specific monitoring is needed during treatment by
clozapine to avoid the risk of agranulocytosis and myocarditis.

Reference:
Communication from the France National Pharmacovigilance
Centre, March 2010.

Malaysia In Malaysia, the clozapine label must include “For specialist’s
use only” and the necessary warnings are related to
hyperglycaemia and diabetes mellitus.

Reference:
Pharmacovigilance Centre, February 2010.

Product Name: Colchicine
CAS Number: 64-86-8
Other Names: Colsalide, Colcrys
Malaysia October 2009 Due to the potential risk of severe drug interactions, including
death, observed in patients treated with colchicine and P-
glycoprotein or strong CYP3A4 inhibitors, new warnings were
added to advise against the concomitant use of these drugs in
patients with renal or hepatic impairment. A dose reduction or
interruption of colchicine treatment should be considered in
patients with normal renal and hepatic function if treatment
with a P-glycoprotein or a strong CYP3A4 inhibitor is required.
In addition, patients should avoid consuming grapefruit and
grapefruit juice while using colchicine.

Reference:

USA 2009 The US FDA has advised health-care professionals not to use
P-glycoprotein or strong CYP3A4 inhibitors in patients with
renal or hepatic impairment who are currently taking
colchicine. Patients are advised to consult the Medication
Guide for important safety information. The above advice has
been issued because the US FDA has received reports of
fatal colchicine toxicity in certain patients taking standard
therapeutic doses of colchicine and concomitant medications
that interact with colchicine, such as clarithromycin.

Reference:


1. Safety Information, US FDA, 30 July 2009 (www.fda.gov).

Product Name: Cyproterone
Other Names: Cyprostat, Cyproteron
Belarus February 2010 Cyproterone-containing drugs with dosage higher than 2 mg
are contraindicated in patients with meningioma or a history of
meningioma. Treatment with cyproterone must be stopped if
patient is diagnosed with meningioma. This decision was
made on the basis of available evidences of a possible causal
relationship between cyproterone acetate and the occurrence
of meningioma.

Reference:
Communication from the Belarus National Pharmacovigilance
Centre, April 2010.

UK 2009 The MHRA has advised health-care professionals that
patients with existing meningioma or a history of meningioma
must not be prescribed cyproterone acetate at doses of 25 mg
per day or higher (Cyprostat-50, Cyprostat- 100, or Androcur-
50). The occurrence of (multiple) meningiomas has been
reported in association with longer-term use (years) of
cyproterone acetate at doses of 25 mg/day or higher.

Reference:
1. Drug Safety Update, MHRA, Volume 3, Issue 3,
October 2009 (www.mhra.gov.uk).
2. WHO Pharmaceuticals Newsletters No. 6, 2009 &
No.1, 2010.

Product Name: Deferasirox
CAS Number: 201530-41-8
Other Names: Exjade
Canada 2009 Canadian Product Monograph has been changed to include a
contraindication in high risk myelodysplastic syndrome (MDS)
patients and in those with advanced malignancies because
these patients are not likely to benefit from iron chelation
therapy due to the expected rapid progression of their
disease.


Reference:
1. Advisories, Warnings and Recalls, Health Canada,
3 December 2009 (www.hc-sc.gc.ca).
2. WHO Pharmaceuticals Newsletter No. 6, 2009 &
No. 1, 2010.

Product Name: Desmopressin
Other Names: Minirin
Iraq January 2008 Desmopressin acetate in lingual tablets is restricted to be used
in primary enuresis, central diabetes insipidus, and enuresis in
adults. It is not to be used by patients over the age of 65 years.

Reference:
Centre, May 2010.

Spain 2008 Desmopressin nasal product has new terms of use
implemented because the nasal formulation was associated
with more adverse drug reactions than the oral formulation.
These new conditions are:
- Dose reduction in primary nocturnal enuresis
- Contraindicated in moderate and severe renal failure
- To be used only when use of the oral formulation is not
possible
- Only for short duration treatment

Reference:
Alertas de Seguridad, AEMPS, 28 March 2008
(www.aemps.es).

Product Name: Dextropropoxyphene
Other Names: Darvocet-N, Capadex, Co-proxamol
European Union 2009 The marketing authorizations for dextropropoxyphene
containing medicines were withdrawn across the EU because
the risks, particularly the risk of potentially fatal overdose, are
greater than their benefits. The withdrawal was recommended
because no other adequate measures could be identified to
sufficiently minimize these risks.


Reference:
1. Press Release, EMA, 25 June 2009 (www.ema.europa.eu).

Iraq March 2009 Dextropropoxyphen has been banned because of high
incidence of adverse drug reactions.

Reference:
Centre, May 2010.

New Zealand 1 August 2009 The consent to distribute dextropropoxyphene containing
medicines will be revoked on 1 August 2010. From this date it
will no longer be legal to sell, distribute, or advertise these
medicines unless exempted under the Medicines Act 1981.
This decision followed a review by the Medicines Adverse
Reaction Committee, which concluded that, overall, the risks
of these medicines exceed their benefits.

Reference:
1. Prescriber Update, Volume 31, No. 1 February 2010

Product Name: Efalizumab
CAS Number: 214745-43-4
Other Names: Raptiva
Canada 2009 Health Canada has issued a recommendation to suspend
efalizumab (Raptiva) in Canada, after the EMA has
determined that the benefit/risk for the product has become
unfavourable due to safety concerns.
Prescribers in Canada are advised not to issue any new
prescriptions for efalizumab and to review the treatment of
patients taking this medicine to assess the most appropriate
alternative.

Reference:
20 January 2009 (www.hc-sc.gc.ca).

European Union 2009 The EMA has recommended the suspension of the marketing
authorization for efalizumab, which is authorized to treat adult
patients with moderate to severe chronic plaque psoriasis.
These decisions are based on reports of confirmed cases of
progressive multifocal leukoencephalopathy (PML) in patients


who had taken efalizumab for more than three years; two out
of the three cases resulted in death. In addition to PML,
efalizumab is associated with other serious side effects,
including Guillain-Barré and Miller-Fisher syndromes,
encephalitis, encephalopathy, meningitis, sepsis and
opportunistic infections. There is not enough evidence to
identify a group of patients in which the benefits of efalizumab
outweigh its risks.

Reference:
1. Press Release, EMA, 19 February 2009

Mexico 2010 Efalizumab has been withdrawn because of the risk of
patients developing PML.

Reference:
Communication from the Mexico National Pharmacovigilance
Centre, May 2010.

Switzerland 2009 The Swiss Agency for Therapeutic Products (Swissmedic)
has banned the distribution and sales of efalizumab due to
cases of PML. The drug is also suspected to be correlated
with other serious adverse effects like Guillain-Barré- and
Miller-Fisher-Syndrome, encephalitis, encephalopathy,
meningitis, sepsis und opportunistic infections. The Agency
has also warned that control by a physician is necessary to
change the treatment for patients currently using the product,
adding that stopping the product abruptly on a patient's own
initiative can lead to an acute worsening of psoriasis and
symptoms of inflammation.

Reference:
1. Announcements, Swissmedic, 20 February 2009
(www.swissmedic.ch).

Turkey 2009 Efalizumab has been withdrawn from the market in Turkey.

Reference:
WHO Pharmaceuticals Newsletter No. 2, 2009.

Ukraine 5 March 2009 Withdrawal of marketing authorization due to risk of serious
side effects.

Reference:
Communication from the Ukraine National Pharmacovigilance
Centre, May 2010.


Product Name: Etoricoxib
CAS Number: 202409-33-4
Other Names: Arcoxia, Algix, Tauxib
European Union 2008 The EMA recommended that the product information for
etoricoxib-containing products should be updated concerning
the risk of cardiovascular side effects. In addition, the CHMP
recommended updating the existing contraindication in
patients with hypertension that is not adequately controlled to
state that patients whose blood pressure is persistently above
140/90 mmHg and has not been adequately controlled should
not take etoricoxib.

Reference:
1. Press Release, EMA, 26 June 2008 (www.ema.europa.eu).

Product Name: Etravirine
CAS Number: 269055-15-4
Other Names: Intellence
Spain October 2009 The Spanish Regulatory Agency (AEMPS) had instructed the
company to update the data sheet about severe rash and
hypersensitivity reaction. The AEMPS recommended that
health-care professionals strictly follow the recommendations
of the technical specifications and discontinue treatment in
cases of severe rash or hypersensitivity reaction.

Reference:
AEMPS, Alertas de Seguridad, 21 October 2009
(www.aemps.es).

Product Name: Fentanyl
Other Names: Ionsys
European Union September The EMA has recommended the suspension of the marketing
2008 authorization of a system (Ionsys) for the transdermal delivery
of fentanyl. This drug delivery system has a defect that could


lead to overdose.

Reference:
1. EMA, 20 November 2008 (www.ema.europa.eu).
2. WHO Pharmaceuticals Newsletters No. 5 & 6, 2008.

Product Name: Flecainide
Other Names: Tambocor, Almarytm, Apocard
New Zealand 2009 Flecainide is not recommended for use in patients with
chronic atrial fibrillation due to the risk of inducing 1:1
atrioventricular conduction, with a consequent paradoxical
increase in ventricular rate when used to treat atrial flutter.
Flecainide is indicated only in patients without structural heart
disease for the prevention, rapid control, or short-term
prophylaxis of supraventricular and ventricular arrhythmias.

Reference:
1. Prescriber Update Volume. 30, No.2, May 2009

Product Name: Gadolinium
Optimark, Omniscan, Magnevist, Magnegita and Gado-MRT
Other Names:
ratiopharm
European Union November High-risk gadolinium-containing contrast agents (Optimark,
2009 Omniscan, Magnevist, Magnegita and Gado-MRT ratiopharm)
are contraindicated in patients with severe kidney problems,
in patients who are scheduled for or have recently received a
liver transplant, and in newborn babies up to four weeks of
age. The prescribing information for all gadolinium-containing
contrast agents should include:
- a warning that the elderly may be at particular risk of
nephrogenic systemic fibrosis (NSF) due to impaired ability of
their kidneys to clear gadolinium from the body
- a statement that there is no evidence to support the initiation
of haemodialysis to prevent or treat NSF in patients not
already undergoing haemodialysis
- a statement that the type and dose of contrast agent used


should be recorded.
These recommendations are aimed at minimizing the risk of
NSF with gadolinium-containing contrast agents.

Reference:
1. Press Release, EMA, 20 November 2009
No. 1, 2010.

Product Name: Gadoversetamide
CAS Number: 131069-91-5
Other Names: Optimark
Canada 2010 Due to the risk of NSF in patients with renal impairment,
gadoversetamide (Optimark) is contraindicated in patients
with:
- acute or chronic severe renal insufficiency (glomerular
filtration rate <30 mL/min/1.73m2), or
- acute renal insufficiency of any severity due to the hepato-
renal syndrome or in the perioperative liver transplantation
period. Gadoversetamide is not recommended for use in
children below the age of two years because the safety and
efficacy of gadoversetamide, as well as impact of use in
patients with an immature kidney function have not been
studied.

Reference:
12 January 2010 (www.hc-sc.gc.ca).
No. 1, 2010.

Product Name: Goserelin
Other Names: Zoladex
Iraq January 2008 Gosorelin (as acetate) implant, 10.8 mg in safe system
syringe applicator is restricted to the use in prostate and
breast cancers only.

Reference:


Centre, May 2010.

Product Name: Human Chorionic Gonadotropin Hormone
CAS Number:
Other Names: A.P.L., Chorex, Pregnyl, Profasi
Iraq April 2008 Registration withdrawn of non-recombinant Human Chorionic
Gonadotropin Hormone, in the strengths 1500 and 5000 IU.

Reference:
Centre, May 2010.

Product Name: Human immune globulin
CAS Number:
Other Names: WinRho
Canada 2010 Due to rare but serious and sometime fatal adverse events of
intravascular hemolysis (IVH) and its complications, human
immune globulin is contraindicated for immune
thrombocytopenic purpura (ITP) patients:
- with ITP secondary to other conditions including leukemia,
lymphoma, or active viral infections with Epstein-Barr virus
(EBV) or hepatitis C (HCV)
- who are elderly with co-morbidities predisposing to acute
hemolytic reaction (AHR) or its complications
- with evidence of autoimmune hemolytic anemia (Evan’s
Syndrome), or Systemic Lupus Erythematosus (SLE) or anti-
phospholipid antibody syndrome (APS)
- who are IgA deficient.

Reference:
22 March 2010 (www.hc-sc.gc.ca).


Product Name: Iron sucrose
Other Names: Venofer
Iraq November The use of Iron sucrose for injection is restricted for use in
2008 hospitals, for in-patients only.

Reference:
Centre, May 2010.

Product Name: Isotretinoin
Other Names: Accutane, Amnesteem, Oratane
New Zealand 2009 As a result of its teratogenicity, isotretinoin is contraindicated
in women of childbearing potential unless an extensive list of
conditions for prescribing are met. Medsafe is currently
assessing the risk mitigation strategies used by the
manufacturers of isotretinoin products in New Zealand.

Reference:
1. Prescriber Update, Volume 30, No.2, Medsafe, May 2009

Switzerland 7 October 2008 The prescription and dispense of isotretinon has been
restricted for female patients based on the teratogenic effect
of isotretinoin. Female patients must confirm with their
signature that they know the risks in connection with the
treatment and will keep the safety measures by adhering to a
strict contraception program. The prescription of isotretinoin
must be restricted to 30 days for women in reproductive age.
A new prescription is needed for continuation of therapy.
Isotretinoin has to be dispensed within 7 days maximally
following issue of the prescription.

Reference:


Product Name: Ivermectin
Other Names: Stromectol
Iraq July 2008 Ivermectin has been restricted to be used in scabies
complicated with hyperkeratotic crusted lesions only.

Reference:
Centre, May 2010.

Product Name: Ketoprofen
Other Names: Ketum, Topfena
Egypt June 2008 A contraindication for ketoprofen dosage of more than 2
mg/kg/day has been decided.
From 19 November 2009 ketoprofen injection and
suppositories are contraindicated in children. From 1 January
2010 ketoprofen is contraindicated in children less than 6
months of age.
All products containing ketoprofen in the form of a gel have
been withdrawn.

Reference:
Communication from the Egypt National Pharmacovigilance
Centre, April 2010.

France 12 January AFSSAPS is suspending the market authorization for
2010 specialties containing ketoprofen gel for which the benefit/risk
is now seen as negative because of the risk of adverse skin
reactions in rare but serious photoallergy.

Reference:
Retraits de lots et de produits, AFSSAPS, January 2010
(www.afssaps.fr).


Product Name: Laronidase
CAS Number: 210589-09-6
Other Names: Aldurazyme
Iraq May 2009 Laronidase is restricted to distribution to specialized centers
only.

Reference:
Centre, May 2010.

Product Name: Letrozole
CAS Number: 112809-51-5
Other Names: Femara
Iraq September Letrozole 205 mg tablets is restricted to be used in
2009 endometriosis and advanced breast cancer only.

Reference:
Centre, May 2010.

Product Name: Mefenamic acid
CAS Number: 61-68-7
Dyfenamic, Dolfenal, Mafepain, Mephadolor, Meftal, Meyerdonal,
Other Names:
Parkemed, Ponstel, Ponstan, Ponstal, Potarlon
Iraq April 2009 Mefenamic acid suspension should not be used in children
under 12 years of age.

Reference:
Centre, May 2010.

Switzerland Mefenamic acid is registered in Switzerland as an analgesic
and antipyretic agent for adults and children, but restricted to
children older than 6 months.

Reference:


Communication from the Switzerland National
Pharmacovigilance Centre, April 2008.

Product Name: Mefloquine
Other Names: Lariam
Iraq July 2009 Mefloquine hydrochloride in tablets and mefloquin lactate in
250 mg tablets have been restricted to control centres for
tranmitted diseases only.

Reference:
Centre, May 2010.

Product Name: Metamizole
Other Names: Dipyrone, Analgin, Noramidopyrine, Novalgine, Minalgin
Philippines Metamizole has been banned in the Philippines.

Reference:
Communication from the Philippines National
Pharmacovigilance Centre, June 2009.

Product Name: Methylphenidate
Other Names: Ritalin, Methylin, Equasym
European Union 2009 The EMA has concluded that methylphenidate-containing
medicines remain suitable for the treatment of children aged
six years or older and adolescents with attention
deficit/hyperactivity disorder (ADHD).
All patients should be screened for any problems with blood
pressure or heart rate and psychiatric disorders before
starting treatment and monitored regularly during treatment.
Treatment should be interrupted at least once a year to


determine whether continuation is needed.

Reference:
1. Press Release, EMA, 22 January 2009.

Product Name: Methylthioninium chloride
CAS Number: 61-73-4
Other Names: Methylene Blue
UK 2009 Use of methylthioninium chloride is not approved in
visualization in surgical procedures or in the management of
intractable hypotension. The MHRA has provided an update
on the risk of central nervous system (CNS) toxicity
associated with an interaction between methylthioninium
chloride (formerly called methylene blue) and serotonergics.
In view of the new reports, the MHRA has strengthened the
advice for health-care professionals, including emphasis on
approved indication. It is also advised that intravenous
methylthioninium chloride should be avoided in patients who
have been treated recently with serotonergic antidepressants,
including SSRIs, clomipramine and venlafaxine.

Reference:
1. Drug Safety Update, MHRA, Volume 2, Issue 9, April 2009
(www.mhra.gov.uk).

Product Name: Metoclopramide
Other Names: Reglan, Primperan
USA 2009 The US FDA has required manufacturers of metoclopramide
to add a boxed warning to the labels about the risk of its long-
term or high-dose use. It is recommended that treatments not
exceed three months. These warnings are based on reports
of tardive dyskinesia in many patients who used
metoclopramide for more than three months.

Reference:
1. FDA News, US FDA, 26 February 2009 (www.fda.gov).


Product Name: Misoprostol
Other Names: Cytotec
Cameroon Misoprostol is registered in Cameroon as a prescription-only-
medicine that may only be used in hospitals under strict
supervision of the prescribers.

Reference:
Communication from theCameroon National
Pharmacovigilance Centre, January 2008.

Product Name: Moxifloxacin
CAS Number: 151096-09-2
Other Names: Avelox, Vigamox
European Union 2008 Moxifloxacin-containing medicines for oral use should only be
prescribed in the treatment of acute bacterial sinusitis, acute
exacerbation of chronic bronchitis and community acquired
pneumonia when other antibiotics cannot be used or have
failed. The reason is increased risk of hepatic reactions.

Reference:
1. Press Release, EMA, 24 July 2008.

Product Name: Mycophenolate mofetil
CAS Number: 115007-34-6
Other Names: CellCept, Myfortic
USA 2009 Due to serious side effects including possible loss of
pregnancy, and higher risk of birth defects, serious infections
and certain cancers, a medication guide for mycophenolate
mofetil (CellCept) has been interoduced to provide important
safety information for patients. Pharmacists are required to
distribute a copy of the medication guide to every patient who
fills a prescription of this product.


Reference:
1. Media Release, US FDA, 12 February 2009 (www.fda.gov).

Product Name: Nifuroxazine
Other Names:
Belgium 2008 Nifuroxazine was withdrawn from the Belgian market due to
its negative benefit-risk profile with a lack of proven efficacy in
human therapy (no resorption in the gastro-intestinal tract)
and the availability of many effective alternative therapies.

Reference:
Communication from the Belgium National Pharmacovigilance
Centre, October 2008.

Product Name: Nimesulide
Other Names: Aldoron, Nisulid, Redaflam, Scafan
Argentina September The National Agency for Drugs, Food and Medical
2009 Technology (ANMAT) through its Department of Evaluation of
Medicinal Products (DEM) and its National Pharmacovigilance
System ordered the prohibition of all medical specialties
containing the NSAID nimesulide as the only active
pharmaceutical ingredient or in combination products.

Reference:
Communication from the Argentina National
Pharmacovigilance Centre, March 2010.

Bhutan 2008 The sale and use of nimesulide was suspended in Bhutan.

Reference:
Communication from the Bhutan National Pharmacovigilance
Centre, December 2008.

Brazil 2008 Nimesulide is used in Brazil for children above 12 years of
age. The leaflet information was changed after two cases of
Reye's syndrome occurred in Portugal.

Reference:
Communication from the Brazil National Pharmacovigilance


Centre, January 2008.

Egypt October 2009 Nimesulide containing products are contraindicated in children
under 12 years in Egypt. The use of systemic formulation of
nimesulide should be restricted to limit the risk of liver injury.
Packages must be modified to contain no more than 30 doses
with duration no more than 15 days. Registration of new
products will not be approved but may be registered for export
only.

Reference:
Centre, May 2010.

Malaysia 2008 The Ministry of Health has cancelled registration of all
registered products containing nimesulide and prohibited the
registration of new products containing nimesulide.

Reference:
Pharmacovigilance Centre, November 2008.

Mexico Nimesulide is restricted to be used in adults and in children
over 2 years of age due to possible hepatotoxic effects.

Reference:
Centre, May 2010.

Singapore July 2008 The Health Sciences Authority (HSA) concluded that the
benefit-risk profile of nimesulide is unfavourable as there is an
increased risk of liver toxicity. Sale of oral preparations
containing nimesulide is suspended.

Reference:
Communication from the Singapore National

Thailand 2008 A temporary decsion was taken in Thailand about nimesulide
in early 2008 as follows:
- Nimesulide is restricted to be used in hospitals only, and
intensive monitoring for liver toxicity must be carried out in all
patients.
- The suspension formulation and 50 mg tablet are withdrawn.
- A study will be conducted to find out the risks and benefits of
this product in the country.

Reference:
Communication from the Thailand National
Pharmacovigilance Centre, January 2008.

Ukraine 16 July 2008 The use of all products containing nimesulide has been
restricted to the treatment of acute pain, symptomatic
treatment of osteoarthritis and primary dysmenorrhoea and


added contraindications for use in children under 12 years of
age, in patients with fever and/or flu-like symptoms, and for
use with potential hepatotoxic drugs, other NSAIDs and
alcohol.

Reference:
Centre, May 2010.

Viet Nam September Drug Administration of Viet Nam has stopped new
2008 applications for oral products containing nimesulide and has
withdrawn all products containing nimesulide already on the
market. This decision does not apply to topical products
containing nimesulide.

Reference:
Communication from the Viet Nam National

Product Name: Nitrous oxide
Other Names:
New Zealand 2009 Prescribers are advised to check vitamin B12 levels in those
with risk factors for vitamin B12 deficiency prior to using
nitrous oxide and to seek specialist advice if necessary.
Prescribers are also advised not to use nitrous oxide
continuously for more than 24 hours or more frequently than
every four days without clinical supervision and
haematological monitoring.

Reference:
1. Prescriber Update Volume. 30, No. 3, August 2009

UK 2008 The MHRA has advised health-care professionals to assess
vitamin B12 levels before nitrous oxide anaesthesia in people
with risk factors for vitamin B12 deficiency. Prolonged use of
nitrous oxide may lead to rare cases of megaloblastic
anaemia and myelopathy resulting from vitamin B12
inactivation.

Reference:
December 2008 (www.mhra.gov.uk).


Product Name: Norfloxacin
Other Names: Noroxin
European Union 2008 The CHMP has advised against the use of oral norfloxacin-
containing medicines in the treatment of acute or chronic
complicated pyelonephritis (kidney infection) due to its poorly
established efficacy and high risk for adverse effects. This
recommendation does not apply to the use of oral norfloxacin-
containing medicines in other types of infection.

Reference:
1. EMA Press Release, 24 July 2008 (www.ema.europa.eu).

Product Name: Orciprenaline
Other Names: Alupent Syrup
UK 2009 The MHRA has annouced the withdrawal of orciprenaline
sulphate due to its low bronchodilating efficacy (compared to
salbutamol) and high incidence of cardiac side effects, mainly
palpitations and tachycardia due to its nonselectivity.

Reference:
November 2009 (www.mhra.gov.uk).
No. 1, 2010.

Product Name: Pergolide
CAS Number: 76-19-7
Other Names: Permax
Switzerland 26 August 2008 The maximal daily dose of Permax has been restricted
(reduced to 3 mg from 5 mg) due to known risk of cardiac
valvulopathy. Additionally, a cardiovascular examination
before treatment has become mandatory.


Reference:

Product Name: Phenazone
CAS Number: 60-80-0
Other Names: Saridon, Antipyrine
Iraq August 2008 Saridon tablets, which contain phenazone, have been banned
because of the high incidence of adverse reactions
(phenazone was banned in Iraq in 1980s).

Reference:
Centre, May 2010.

Product Name: Phenylpropanolamine
Other Names: Norephedrine
Indonesia In Indonesia phenylpropanolamine (PPA) is only approved as
nasal decongenstant in cough and cold products with a
recommended dosage of 10 - 25 mg and a maximum dosage
per day of 75 mg (adults) and 37.5 mg (children 6 - 12 years
old).

Reference:
Communication from the Indonesia National

Uganda In Uganda, all products containing phenylpropanolamine have
been de-registered. Market authorization holders were
advised to reformulate products containing
phenylpropanolamine, using a different composition, and re-
apply for registration if interested.

Reference:
Communication from the Uganda National Pharmacovigilance
Centre, December 2009.


Product Name: Pimecrolimus
CAS Number: 137071-32-0
Other Names: Elidel
Mexico 2010 Pimecrolimus should only be used for short periods of time at
the lowest amount possible. It should not be used in children
younger than 2 years or in immunocompromised patients.

Reference:
Centre, May 2010.

Product Name: Piroxicam
Other Names: Feldene
Canada 2009 Health Canada has recommended that piroxicam should no
longer be used to treat acute or short-term pain and
inflammation due to an increased risk of serious skin
reactions and gastrointestinal problems relative to other
similar drugs. Piroxicam can still be prescribed for the
symptomatic relief of chronic pain and inflammation in
patients suffering from certain types of chronic arthritis
(osteoarthritis, rheumatoid arthritis and ankylosing
spondylitis).

Reference:
25 June 2009 (www.hc-sc.gc.ca).

Product Name: Promethazine
CAS Number: 60-87-7
Other Names: Phenergan, Romergan, Avomine
USA 16 September Due to the risks of of severe tissue injury, including gangrene,
2009 and subsequent amputation associated with intravenous
administration of promethazine, the preferred route of
administration for this product is deep intramuscular injection;


subcutaneous injection is contraindicated.

Reference:
1. Safety Information, US FDA, 16 September 2009
(www.fda.gov).

Product Name: Propylthiouracil
CAS Number: 51-52-5
Other Names: Prothiucil, Propacil
Malaysia Propylthiouracil should not be used in paediatric patients
unless the patient is allergic or intolerant to available
alternatives. Due to the potential risk of serious hepatotoxicity
including liver failure and death, patients should be closely
monitored for signs and symptoms of liver injury, espeically
during the first six months of treatment.

Reference:
Pharmacovigilance Centre, June 2009.

USA 3 June 2009 Because of the risk of serious liver injury, including liver failure
and death, with the use of propylthiouracil (PTU), it is
recommended only as a second-line therapy; it should be
reserved for patients who are intolerant to methimazole or
patients with Grave's disease, who are in their first trisemester
of pregnancy, or who are allergic to or do not tolerate
methimazole (MMI). It has also been advised that PTU should
not be used in paediatric patients unless the patient is allergic
to or does not tolerate MMI, and there are no other treatment
options available.

Reference:
1. FDA Alert, US FDA, 3 June 2009 (www.fda.gov).

Product Name: Pseudoephedrine
CAS Number: 90-82-4
Other Names: Genaphed, Robidrine, Sudafed
Egypt 18 June 2009 Pseudoephedrine is contraindicated in children less than two
years of age. Registration of new products containing


pseudoephedrine will not be approved.

Reference:
Centre, April 2010.

Iraq May 2008 Pseudoephedrine hydrochloride has been banned because of
an increased risk of adverse reactions.

Reference:
Centre, May 2010.

Product Name: Rimonabant
CAS Number: 168273-06-1
Other Names: Acomplia
Switzerland 30 Ocotober The distribution and sale of rimonabant have been banned
2008 (suspension of marketing authorization) due to increased risk
of serious psychiatric disorders.

Reference:

Ukraine 29 January A voluntary recall has been conducted by Sanofi-Aventis.
2009

Reference:
Centre, May 2010.

Product Name: Sibutramine
CAS Number: 106650-56-0
Other Names: Lindaxa, Meridia, Minimectil, Redact, Reductil, Sibutral
Armenia 2010 Scientific Centre of Drug and Medical Technology Expertise,
Ministry of Health of the Republic of Armenia (SCDMTE MoH)
suspended marketing authorization for sibutramine weight-
loss medicine associated with increased risk of cardiovascular
events, on the basis of unsatisfactory ”benefit/risk” index.

Reference:
Communication from the Armenia National


Belarus March 2010 Sibutramine-containing medicines have been suspended and
recalled from the market. The suspension will remain until the
manufacturers are able to provide sufficient data that
sibutramine’s benefits clearly outweigh its risks in certain
patient groups. This decision is based on currently available
data suggesting that cardiovascular risks of sibutramine-
containing medicines outweigh its therapeutical benefit in
reducing body weight.

Reference:
Centre, April 2010.

Brazil February 2010 A decision was made in February 2010 to keep sibutramine
available in Brazil, but under a stricter prescription scheme
(changed from C to B2). A final decision will be made based
on the report from the Sibutramine Cardiovascular Outcome
Trial (SCOUT).

Reference:
Communication from the Brazil CEATOX Centre, March 2010.

Egypt 11 February The marketing authorizations for sibutramine (Reductil,
2010 Sibutral) have been cancelled.

Reference:
Centre, April 2010.

European Union 21 January The EMA has advised a suspension on the prescription and
2010 distribution of sibutramine due an increased risk for serious
cardiovascular events in patients with a history of
cardiovascular disease.

Reference:
1. Press Release, Questions and Answers, EMA,
21 January 2010 (www.ema.europa.eu).
No. 1, 2010.

Saudi Arabia 2010 The marketing authorizations for sibutramine (Reductil,
Sibutral) have been cancelled.

Reference:
WHO Pharmaceuticals Newsletters No. 6, 2009 &
No. 1, 2010.

Sudan 2010 The registration of sibutramine in Sudan has been
suspended. Sibutramine has been registered in Sudan but
was never marketed.

Reference:
Communication from the Sudan National Pharmacovigilance
Centre, March 2010.


Switzerland 29 March 2010 The distribution and sale of sibutramine have been banned
(suspension of marketing authorization) due to increased
cardiovascular risk observed in the SCOUT study.

Reference:

Ukraine 15 April 2010 Marketing authorization of products containing sibutramine
has been suspended due to adverse cardiovascular events
associated with the drug.

Reference:
Centre, May 2010.

USA November Sibutramine is contraindicated in patients with a history of
2009 cardiovascular disease, including coronary artery disease
(e.g., heart attack, angina), stroke or transient ischaemic
attack, cardiac arrhythmias, congestive heart failure,
peripheral arterial disease, or uncontrolled hypertension (e.g.
> 90/145 mmHg) since there are reports of cadiovascular
events (heart attack, stroke, resuscitated cardiac arrest, or
death) related to sibutramine use in patients with a history of
cardiovascular disease. Patients' blood pressure and heart
rate should be monitored regularly. Sibutramine should be
discontinued in patients who do not lose at least 5% of their
baseline body weight within the first three to six months of
treatment.

Reference:
1. Safety Information, US FDA, 20 November 2009,
21 January 2010 (www.fda.gov).
2. WHO Pharmaceuticals Newsletter No. 6, 2009 &
No. 1, 2010.

Product Name: Sodium phosphate
Other Names: Fleet Enema, LaCrosses Complete, Visicol
Canada March 2009 Health Canada has warned the public against using over-the-
counter oral sodium phosphate products as bowel cleansers
due to serious adverse effects, including electrolyte
disturbances and kidney damage. However, these products
are still considered to be safe and effective for laxative use.

Reference:
5 August 2009 (www.hc-sc.gc.ca).



Iceland 17 May 2009 Phosphoral (oral solution, 10.8 g/45 ml g 24.4 g/45 ml) is no
longer sold over the counter in Iceland, due to reports of
serious adverse events.

Reference:
Communication from the Iceland National Pharmacovigilance
Centre, May 2010.

USA 11 December The US FDA has issued an alert that over-the-counter oral
2008 sodium phosphate (OSP) laxative products should not be
used for bowel cleansing prior to colonoscopy and other
procedures due to the risk of acute phosphate nephropathy.
The US FDA is requiring the manufacturers of the two
prescription-only OSPs to add a Boxed Warning to the
labelling, as well as to develop and implement a risk
evaluation and mitigation strategy (REMS), which will include
a Medication Guide.

Reference:
1. FDA Alert, US FDA, 11 December 2008 (www.fda.gov).

Product Name: Stichopus sp. (S. horrens, S. variegatus)
CAS Number:
Other Names: Sea Cucumber, Gamat
Malaysia 2008 The registration of Gamat products from Healwell
Pharmaceuticals was suspended and all products in the
market containing Stichopus sp. were recalled following
adverse reaction reports received on renal failure.

Reference:

Product Name: Tacrolimus
CAS Number: 104987-11-3
Other Names: Protopic
Mexico 2010 Tacrolimus (topical preparation) should not be used in
children younger than 2 years and in immunocompromised
patients. It should only be used for short periods of time at the


lowest amount possible.

Reference:
Centre, May 2010.

Product Name: Telithromycin
CAS Number: 173838-31-8
Other Names: Ketek
Egypt 30 October The use of telithromycin is restricted to the following
2008 indications:
- acute bacterial sinusitis
- acute bacterial exacerbations of chronic bronchitis.
In addition, telithromycin is contraindicated in patients with
myasthenia gravis. There is also a strengthened warning on
specific drug-related adverse events including visual
disturbances and loss of consciousness.

Reference:
Communication from Egypt National Pharmacovigilance
Centre, April 2009.

Product Name: Thalidomide
CAS Number: 50-35-1
Other Names: Thalix
European Union January 2009 Thalidomide is used to treat multiple myeloma in combination
with melphalan and prednisone in patients who have not been
treated for multiple myeloma before.
It is only to be used in patients aged over 65 years, and in
younger patients if they cannot be treated with high-dose
chemotherapy.
Thalidomide must be prescribed and dispensed according to
a special programme to prevent the exposure of unborn
children to the medicine.

Reference:
European Public Assessment Report (EPAR), EMA,
January 2009
(www.ema.europa.eu/humandocs/PDFs/EPAR/thalidomidecel


gene/H-823-en1.pdf).

Sudan July 2009 Thalidomide was registered in Sudan in July 2009 under the
name Thalix, for multiple myeloma, in concentrations 50 mg
and 100 mg. The use of the medicince will be restricted to:
- distribution in special myeloma centres only
- prescription-only drug from specialists
- prescription should be written in Arabic language.

Reference:
Communication from the Sudan National Pharmacovigilance

Product Name: Tibolone
Other Names: Livial
UK February 2009 Tibolone is contraindicated in women with known or
suspected breast cancer and those with a history of breast
cancer due to an increased risk for recurrence of breast
cancer.

Reference:
February 2009 (www.mhra.gov.uk).

Product Name: Tinzaparin
Other Names: Innohep
USA 2008 The US FDA has recommended the use of alternative
treatments to tinzaparin sodium injection in elderly patients
over 70 years of age with renal insufficiency and deep vein
thrombosis, and/or pulmonary emboli due to the increased
risk of death.

Reference:
1. Communication about an Ongoing Safety Review, US FDA,
2 December 2008 (www.fda.gov).


Product Name: Tiotropium
CAS Number: 186691-13-4
Other Names: Spiriva
Iraq March 2009 Tiotropium solution for inhalation has been banned due to the
lack of safety information.

Reference:
Centre, May 2010.

Product Name: Toremifene
Other Names: Fareston, Acapodene
European Union January 2009 Due to concerns over QT-prolongation caused by toremifene,
the EMA has advised against the use of toremifene in patients
at risk for prolonged QT intervals and other heart problems
including electrolyte disturbances (particularly hypokalaemia),
clinically relevant bradycardia, clinically relevant heart failure
with reduced left-ventricular ejection fraction, and a history of
symptomatic arrhythmia. Additionally, using toremifene with
other medicines known to cause QT-prolongation is not
recommended.

Reference:
1. Press Release, EMA, 22 January 2009
2. Alert No. 120, Information Exchange System, WHO,
23 January 2009 (www.who.int/medicines).

Switzerland 12 February Due to the risk of QT-interval prolongation, toremifene is
2009 contraindicated in patients with an increased risk for this
adverse event.

Reference:


Product Name: Tramadol
Other Names: Tramal, Tramundin
Bahrain 2009 In Bahrain, tramadol is a controlled medicine dispensed only
through special control drug prescription due to abuse
problems.

Reference:
Communication from the Bahrain National Pharmacovigilance

Product Name: Triamcinolone
Other Names: Kenalog, Aristocort, Nasacort
Canada July 2009 Intravitreal and intraocular injection of triamcinolone is not
authorized in Canada due to ocular adverse reactions
including retinal detachment and vitreous hemorrhage, which
can later progress into cataracts, steroid-induced glaucoma,
and endophthalmitis. Currently, only intramuscular and intra-
articular administration, or injection into tendon sheaths or
ganglia are approved for use.

Reference:
1. Canadian Adverse Reaction Newsletter, Health Canada,
Volume 19, Issue 3, July 2009 (www.hc-sc.gc.ca).

Product Name: Vincristine
CAS Number: 57-22-7
Other Names: Vincasar
Iraq May 2008 Vincristine should only be administered intravenously and not
by any other route.

Reference:


Centre, May 2010.

Product Name: Zinc-containing intranasal products
CAS Number:
Other Names: Zicam Nasal Gel, Zicam Nasal Swab
USA 2009 The US FDA has warned against the use of three zinc-
containing intranasal products sold as over-the-counter cold
remedies (Zicam Nasal Gel and Nasal Swab) due to their
association with a long-lasting or permanent loss of sense of
smell. These products have not been shown to be effective in
reducing the duration or severity of cold symptoms. This
advisory does not apply to oral zinc tablets and oral lozenges.

Reference:
1. Safety Information, US FDA, 16 June 2009.

COMBINATION PRODUCTS 39

Product Name: Baithach

CAS Number:
Content: Desmodium, Adenosmatis, Scutellaria, Curcuma, Areca,
Other Names:
Citrus, Magnolia, Imperata, Saussurea, Rheum
Armenia 2009 The SCDMTE MoH did not approve the marketing
authorization of Baithach (complex of herbal extracts
recognized as a non-traditional herbal drug) because the
description of plant properties and indications were not
consistent with those described in the standard monographs.

Reference:
Pharmacovigilance Centre April, 2010.

Product Name: Belly cut capsules
CAS Number:
Other Names:
Iraq November Because of a high rate of adverse reactions and the fact that it
2008 is illegally distributed and not registered in Iraq, Belly Cut
capsules have been withdrawn.

Reference:
Centre, May 2010.

Product Name: Chloral hydrate and triclofos
CAS Number:
Other Names: Aquachloral, Somnos, Novo-Chlorhydrate, Welldorm
UK 2009 The MHRA has advised health-care professionals that chloral
hydrate (Welldorm) and triclofos are indicated as an adjunct to
non-pharmacological therapies only for the short-term
treatment of severe insomnia that interferes with normal daily
life and where other therapies have failed. The product
information for these medicines has recently been changed to
reflect current clinical practice where they are not first-line

40 COMBINATION PRODUCTS

options for insomnia.

Reference:
June 2009 (www.mhra.gov.uk).

Product Name: Chloroproguanil and dapsone
CAS Number:
Other Names: LapDap
Ghana 2008 The anti-malarial combination chloroproguanil and dapsone
has been withdrawn following demonstration of post-treatment
haemolytic anaemia in G6PD deficient patients in a phase III
clinical trial.

Reference:
Communication from the Ghana National Pharmacovigilance
Centre, June 2010.

Product Name: Clindamycin and miconazole
CAS Number:
Other Names: Clindamed
authorization of Rhinoil, a combination medication containing
clindamycin and miconazole, used for the local treatment of
nasal inflammation/infection because the combination was
estimated as irrational and can cause serious adverse
reactions.

Reference:


Product Name: Dietary supplements
CAS Number:
Other Names: Hydroxycut
USA 2009 The US FDA has alerted the public and health-care
professionals about dietary supplement products named
Hydroxycut that are associated with serious liver injuries, and
warned consumers not to take these products. The Agency
has received 23 reports of serious health problems ranging
from jaundice and elevated liver enzymes, to liver damage
requiring liver transplants. One death due to liver failure has
been reported. Other health problems reported include
seizures, cardiovascular disorders, and rhabdomyolysis. The
products have been recalled by the company.

Reference:
1. Media release, US FDA, 1 May 2009 (www.fda.gov).

Product Name: Dismectide
CAS Number:
Other Names: Smecta sachets
Iraq January 2009 Dismectide sachets are to be used only in adults since there
is not enough safety information related to their long term use.

Reference:
Centre, May 2010.

Product Name: Ephedrine and kava kava products
CAS Number:
Other Names: Life Choice ephedrine hydrochloride, Life Cholice kava kava
Canada 2008 Health Canada has advised consumers against using natural
health products Life Choice ephedrine hydrochloride 30 mg
capsules and Life Choice kava kava (kavain) 150 mg
capsules. The advice came as the agency took steps to
prevent these products, which have not been approved, from


entering the Canadian market. According to Health Canada,
Life Choice ephedrine contains an excessive amount of
ephedrine, and when taken alone or in combination with
caffeine or other stimulants may lead to serious, potentially
life-threatening adverse events. Kava kava-containing
products have been linked to liver dysfunction and associated
with coordination disorders, muscle weakness, and kava
dermopathy (a peculiar scaly eruption of the skin).

Reference:
1. Media Release, Health Canada, 21 August 2008
(www.hc-sc.gc.ca).

Product Name: Levonorgestrel + Intra-uterine Contraceptive
Devices (IUCDs)
CAS Number:
Other Names:
Iraq November The combination should only be used in specialized centres,
2008 for uterine bleeding, where other treatments have failed.

Reference:
Centre, May 2010.

Product Name: Neomycin sulphate, polymyxine sulphate and
nystatin
CAS Number:
Other Names: Polygynax
Cameroon In Cameroon, Polygynax (Neomycine sulphate 35 000 IU,
Polymyxine sulphate 35 000 IU, Nystatin 100 000 IU) is
registered. Its use is not recommended during pregnancy and
it must not be taken while breast-feeding.

Reference:
Communication from the Cameroon National


Product Name: Paracetamol and pseudoephedrine
CAS Number:
Other Names:
Ghana 2009 The registration of oral paediatric formulations containing
ibuprofen and paracetamol as a fixed-dose combination has
been suspended as there is no scientific evidence to justify
the use of the combination in children as compared to using
the two components separately.
Reference:
Communication from the Ghana National Pharmacovigilance
Centre, June 2010.

Iraq May 2008 The combination should not contain less than 500 mg
paracetamol to be effective as a therapeutic dose and not
more than 30 mg of pseudoephedrine to decrease the risk of
adverse reactions.

Reference:
Centre, May 2010.

Product Name: Rhinoil
CAS Number:
Other Names: Vitamin A, Anise oil, Eucalipt oil, Mint oil, Camphor
authorization of Rhinoil, a combination medication for the local
treatment of nasal inflammation /infection because
combination was estimated as irrational and can cause
serious adverse reactions.

Reference:

Product Name: Tadimax
CAS Number:
Content: Crinum sp., Anemarrhena, Phellodendron sp., Leonurus,
Other Names:
Prunus, Alisma, Paeonia, Cinnamomum


authorization of Tadimax (complex of herbal extracts used as
a non-traditional herbal drug), due to inconsistencies between
the description of plant properties in monographs and
indications for medicinal use.

Reference:

Product Name: Vitrum Beauty Elite
CAS Number:
Content: Vitamins, minerals, microelements, enzymes, amino
Other Names:
acids, herbal extracts
authorization of Vitrum Beauty Elite due to the lack of data on
efficacy and safety.

Reference:

GROUP PRODUCTS 45

Product Name: Angiotensin converting enzyme inhibitors and
angiotensin II receptor antagonists
CAS Number:
Other Names:
Belarus March 2009 Products containing angiotensin converting enzyme (ACE)
inhibitors and angiotensin II receptor antagonists should not
be initiated during pregnancy, and are not recommended
during the first trimester of pregnancy. Patients planning
pregnancy should be changed to alternative antihypertensive
treatment and treatment should be stopped immediately when
pregnancy is diagnosed. Products are not recommended
during breastfeeding, especially while nursing a newborn or
preterm infant.

Reference:
Centre, April 2010.

UK 2009 ACE inhibitors (catopril, enalapril or quinapril) are not
recommended in the first few weeks after delivery because of
the possibility of profound neonatal hypotension; preterm
babies may be at particular risk. ACE inhibitors and
angiotensin II receptor antagonists should not be used at any
stage of pregnancy unless absolutely necessary. Angiotensin
II is essential for normal kidney development, and the use of
ACE inhibitors and angiotensin II receptor antagonists in late
pregnancy has been associated with adverse effects on the
kidney and other congenital anomalies.

Reference:
1. Drug Safety Update, MHRA, Volume 2, Issue 10, May 2009
(www.mhra.gov.uk).

Product Name: Nasal sprays
CAS Number:
Other Names:
Norway 19 November Nasal spray (oxymethazoline, xylomethazoline,
2008 ipratropiumbromide) use is restricted for children younger
than 2 years of age.

Reference:
Communication from the Norway National Pharmacovigilance

46 GROUP PRODUCTS

Centre, April 2010.

Product Name: Codeine and dihydrocodeine-containing
medicines
CAS Number:
Other Names:
UK 2009 The MHRA announced a package of measures to minimize
the risk of overuse and addiction associated with over-the-
counter medicines containing codeine and dihydrocodeine
(DHC). The Patient Information leaflet and labels will state
that these products can cause addiction or overuse headache
if used continuously for more than three days. All indications
related to colds, flu, coughs and sore throats, and references
to minor painful conditions will be removed. The package size
and advertising will be also regulated.

Reference:
1. Safety warnings and messages for medicines, MHRA,
2 September 2009 (www.mhra.gov.uk).

Product Name: Cough and cold medicines
CAS Number:
Other Names:
Barbados April 2009 Prescription is needed for cold medicines for children under
six years of age.

Reference:
Communication from the Barbados National

Belarus September Use of cough and cold medicines is contraindicated in
2009 children under 6 years of age due to unfavourable risk/benefit
ratio. For children aged 6 to 12 years, a strengthened warning
and requirement for child resistant packaging were
introduced.

Reference:
Centre, April 2010.

Canada 2009 Health Canada has advised the public that certain over-the-
counter cough and cold medicines should not be used in
children under 6 years of age, following a review of available
data. The Agency also says that cough and cold medicines
marketed for use in children will require enhanced labeling
and packaging.

Reference:
1. Canadian Adverse Reaction Newsletter Volume 19,
Issue 2, Health Canada, April 2009 (www.hc-sc.gc.ca).

Kenya 2009 The Kenya Pharmacy and Poisons Board (PPB) stated that
the following OTC cough and cold medicines are not
recommended in children under 6 years of age:
- antitussives (dextromethorphan and pholcodine)
- expectorants (guaifenesin and ipecacuanha)
- nasal decongestants (ephedrine, oxymetazoline,
phenylephrine, pseudoephedrine and xylometazoline)
- antihistamines (brompheniramine, chlorpheniramine,
diphenhydramine, doxylamine, promethazine and tripolidine)
Cough and cold medicines containing these ingredients will
be available for children between ages 6 to 12 years, but only
in pharmacies.

Reference:
1. Statement on cough and cold medicines, Frequently Asked
Questions, PPB, 13 March 2009.

Malaysia April 2009 Any oral liquid cough and cold preparations containing
antihistamines, antitussives, expectorants and decongestants
as a single ingredient or in combination should include the
following warning in the label and package insert:
- Not to be used in children less than 2 years old
- To be used with caution and doctor’s advice in children 2 to
6 years of age.

Reference:
Pharmacovigilance Centre, May 2010.

New Zealand 2010 Cough and cold medicines containing the following
substances are contraindicated for use in children under 6
years of age: brompheniramine, chlorpheniramine,
dextromethorphan, diphenhydramine, doxylamine,
guaifenesin, ipecacuanha, phenylephrine, pholcodine,
promethazine, pseudoephedrine and triprolidine.
This decision is based on the conclusion of the Cough and
Cold Review Group (CCRG) that the risk-benefit balance of

48 GROUP PRODUCTS

cough and cold medicines is unfavourable in children under 6
years of age.

Reference:
1. Prescriber Update Volume. 31, No.1, February 2010

UK 2009 The MHRA has recommended that parents and carers should
no longer use over-the-counter cough and cold medicines in
children under 6 years of age, because there is no evidence
that these medicines work and can cause side effects such as
allergic reactions, effects on sleep or hallucinations. For 6 to
12 year-old children, these medicines will continue to be
available but only in pharmacies.

Reference:
1. Safety information, MHRA, 28 February 2009.

USA 2008 The US FDA recommends that OTC cough and cold
medicines should not be given to children under 4 years of
age. Many pharmaceutical companies have voluntarily
changed the labeling for OTC cough and cold medicines in
order to minimize the risk of dosing errors and accidental
ingestions.

Reference:
1. Media Release, US FDA, 8 October 2008 (www.fda.gov).
2. WHO Pharmaceuticals Newsletters No. 5 & No. 6, 2008.

Product Name: Ergot-derived dopamine agonists
CAS Number:
Other Names:
EU 2008 The EMA has recommended revising the product information
for ergot-derived dopamine agonists with new warnings and
contraindications relating to the risk of fibrosis. Although the
development of fibrosis symptoms is a known adverse effect
of ergot-derived dopamine agonists, new data have
suggested that fibrosis may start long before the onset of
symptoms. The EMA affirmed that marketing authorizations
should be maintained, but that new warnings and
contraindications should be added to the relevant product
information
- Bromocriptine and dihydroergocryptine is contraindicated for
patients with pre-existing valve problems.

- The maximum dose of bromocriptine is restricted to 30 mg
per day.
- Warning on the possible risk of fibrosis is required in patients
taking bromocriptine, dihydroergocryptine and lisuride for long
periods.

Reference:
1. Media Release, EMA, 26 June 2008 (www.ema.europa.eu).

Spain March 2008 Ergot-derived dopamine agonists are contraindicated in
patients with valvular heart diseases or fibrotic disorders.
These warnings do not apply to short-term treatments for the
inhibition/suppression of lactation or to treatment with lisuride.

Reference:
AEMPS, Alertas de Seguridad, 9 October 2008
(www.aemps.es/actividad/alertas/usoHumano/seguridad).

Product Name: Erythropoiesis-stimulating agents
CAS Number:
Other Names:
USA 2008 The US FDA has informed health-care professionals of
modifications to prescribing information for erythropoiesis-
stimulating agents (ESAs). The changes clarify the US FDA-
approved conditions for use of ESAs in patients with cancer
and revise directions for dosing to state the haemoglobin level
at which treatment with an ESA should be initiated.

Reference:
1. Follow up to the 3 January 2008 communication, US FDA
(www.fda.gov).

Product Name: Herbal cold and flu products
CAS Number:
Other Names:
Australia December The Australia Therapeutic Goods Administration (TGA) has
2008 announced the voluntary recall of two herbal cold and flu
medicines by the company, following reports of a number of
allergic and anaphylactic reactions. Those products (Nyal Day

50 GROUP PRODUCTS

& Night Cold & Flu Fighter tablets and Nyal Cold & Flu Fighter
tablets) contain the herbs Andrographis paniculata
(Andrographis), Sambucus nigra (Elderberry), Salix alba
(White willow) and Valeriana officinalis (Valerian).

Reference:
1. Health alert, TGA, 19 December 2008 (www.tga.gov.au).

Product Name: Inhalers with CFC propellants
CAS Number:
Other Names:
Iraq November Chloroflourocarbon (CFC) propellants for inhalers must be
2008 replaced with other propellants, for example, 1,1,1,2,-
tetrafluoroethane.

Reference:
Centre, May 2010.

Product Name: Long-acting beta-agonists
CAS Number:
Other Names:
USA February 2010 A revised medication guide on the use of long-acting beta-
agonists (LABAs) was issued based on studies showing an
increased risk of severe exacerbation of asthma symptoms,
leading to hospitalizations in paediatric and adult patients as
well as death in some patients using LABAs for the treatment
of asthma. The use of LABAs is contraindicated without the
use of an asthma controller medication such as an inhaled
corticosteroid. Due to insufficient data on whether using
LABAs with an inhaled corticosteroid reduces or eliminates
the risk of asthma-related death and hospitalizations, the
Agency is requiring the manufacturers of LABAs to conduct
studies evaluating the safety of LABAs when used in
conjunction with an inhaled corticosteroids.

Reference:
1. Safety Information, US FDA, 18 Feb 2010 (www.fda.gov).

Product Name: Oral preparations containing alcohol
CAS Number:
Other Names:
Iraq April 2008 The use of alcohol in oral preparations has been restricted to
no more than 10% in adults and up to 5% in children
(preferable without alcohol).

Reference:
Centre, May 2010.

Product Name: Salicylates
CAS Number:
Other Names:
UK 23 April 2009 Topical oral (oral gel) pain relief products containing salicylate
salts are contraindicated in children and young people under
the age of 16 years. Substantial systemic level of salicylate
could be reached from the overuse of salicylate-containing
topical oral gels, which could lead to salicylate toxicity
reactions that resemble Reye's syndrome. These products are
therefore contraindicated in children and young people under
the age of 16 years in line with other oral salicylate-containing
preparations.

Reference:
1. Safety warnings and messages for medicines, MHRA,
23 April 2009 (www.mhra.gov.uk).

Product Name: Short acting beta-agonists (SABAs)
CAS Number:
Other Names:
Belarus February 2010 These products are contraindicated as tocolytic agents in
patients with pre-existing ischaemic heart disease and in
those with significant risk factors for ischaemic heart disease.
For other patients who have undergone tocolytic therapy with

52 GROUP PRODUCTS

SABAs, a strengthened recommendation for cardiorespiratory
function supervision, including ECG monitoring, has been
issued. Treatment should be discontinued if signs of
myocardial ischaemia develop. Restrictions are based on the
available evidence that SABAs can increase the risk of
myocardial ischaemia.

Reference:
Centre, April 2010.

Product Name: Vitamins
CAS Number:
Other Names:
Iraq September The use of vitamin B complex injection (i.m or slow i.v) has
2008 been banned because it is not effective in either therapeutic
or preventive use.

Reference:
Centre, May 2010.

Iraq September Vitamin B12 is only to be used as hydroxycobalamine if used
2008 alone, and as cyanocobalamine if used in combination
products.

Reference:
Centre, May 2010.

Iraq January 2010 Vitamin A is not to be used in the first three months of
pregnancy because of its teratogenic potential, and preferably
not to be given to nursing mothers unless there is vitamin A
deficiency.

Reference:
Centre, May 2010.

Essential Medicines and Pharmaceutical Policies
Quality Assurance and Safety: Medicines
Health Systems and Services

World Health Organization
20 Avenue Appia
1211 Geneva 27
www.who.int/medicines

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