[e-med] WHO DRUG INFORMATION VOL 22, NUMBER 1

["remed" <remed@remed.org>]

[un document de référence pour améliorer l'usage des médicaments et qui malheureusement n'est plus traduit en français depuis une dizaine d'année...CB]

De : WHO Druginformation [mailto:DRUGINFORMATION@WHO.INT] De la part de
Encrenaz, Christine
Envoyé : vendredi 23 mai 2008 14:10
À : DRUGINFORMATION@WHO.INT
Objet : WHO DRUG INFORMATION VOL 22, NUMBER 1


WHO DRUG INFORMATION highlights topics of current concern, 
recent regulatory decisions and standard-setting activities, 
with a focus on the processes linking regulatory activity 
to therapeutic practice. It presents selected contributions 
portraying a variety of viewpoints from different disciplines and 
pharmaceutical sciences. WHO DRUG INFORMATION can be viewed at: 

http://www.who.int/druginformation 

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WHO DRUG INFORMATION, Volume 22, Number 1  

Our first issue of WHO DRUG INFORMATION for 2008 opens with a feature
article on new regulatory systems being devised to address the growing
market of biosimilar products.

Pharmacovigilance Focus presents a report from the Annual Meeting of the WHO
Programme for International Drug Monitoring held in Buenos Aires, Argentina,
and proposes some interesting solutions for data base reporting of adverse
drug reactions.

The Current Topics section provides information on new licensing mechanisms
for vaccines in the Americas, a report on counterfeit artesunate in
South-east Asia and the ort of a meeting on medicines pricing held with
Ministers from the Eastern Mediterranean countries. 

The section on Safety and Efficacy gives the latest information on signals
and reports of adverse drug reactions, with other news from around the
world, including labeling changes. This is complemented by Regulatory Action
and News which provides the most recent developments from regulatory
authorities, and particularly those having an impact on decision-taking.

Several informational documents and events are reviewed and the journal
concludes with Recommended list number 59 of International Nonproprietary
Names (INN).

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Table of Contents

Challenges in Biotherapeutics 
Regulatory pathways for biosimilar products     3 
Pharmacovigilance Focus 
WHO Programme for International Drug Monitoring: annual meeting         6 
Safety and Efficacy Issues 
Recall of heparin products extended             10 
Contaminated heparin products recalled  10 
DacartTM development terminated and LapdapTM recalled   11 
Varenicline and suicide attempts                        11 
Norelgestromin-ethynil estradiol: infarction and thromboembolism 12 
Emerging cardiovascular concerns with rosiglitazone             12 
Disclosure of transdermal patches                                       13 
Statement on safety of HPV vaccine                                      13 
IVIG: myocardial infarction, stroke and thrombosis              14 
Erythropoietins: lower haemoglobin levels                               15 
Erythropoietin-stimulating agents               15 
Pregabalin: hypersensitivity reactions  16 
Cefepime: increased mortality?                  16 
Mycophenolic acid: pregnancy loss and congenital malformation   17 
Carbamazepine and skin reactions                        17 
Canada Vigilance: a new name and database                               18 
Desmopressin and hyponatraemia                  18 
Regulatory Action and News 
Influenza virus vaccines: northern hemisphere winter    19 
Lumiracoxib-containing medicines: withdrawal                    19 
Thalidomide approved for multiple myeloma       19 
New genetic test for breast cancer              20 
Natalizumab for moderate-to-severe Crohn disease                20 
First test to detect and identify 12 respiratory viruses        21 
Miglustat: withdrawal by manufacturer           21 
Voluntary withdrawal of clobutinol cough syrup                  22 
Current Topics 
Proposed harmonized requirements: licensing vaccines in the Americas    23 
Sixteen types of counterfeit artesunate circulating in South-east Asia  24 
Eastern Mediterranean Ministers tackle high medicines prices
24 
ATC/DDD Classification 
ATC/DDD Classification (temporary)              26 
ATC/DDD Classification (final)                  28 
Consultation Document 
International Pharmacopoeia 
Cycloserine                                                     30 
Cycloserine capsules                                    33 
Recent Publications, Information and Events 
Assessing the quality of herbal medicines: contaminants and residues    36 
Launch of procurement and supply management website             36 
Malaria research collection published                                   36 
New pricing bulletin                                    37 
How to improve the use of medicines by consumers                37 
Model quality assurance system for procurement agencies         38 
Training courses in management and supply       38 
Pharmacists work to improve use of generics                     39 
Recommended International Nonproprietary Names: 
List 59                                                                 41