Le bulletin d'information sur le médicament de l'oms (WHO drug information) souligne les sujets d'actualité, les décisions réglementaires récentes et les activités liées à l'établissement de standards, avec un accent particulier sur les processus qui lient l'activité de régulation à la pratique thérapeutique.
Il présente des contributions présentants des points de vue variés de différentes disciplines et sciences pharmaceutiques.
Le WHO DRUG INFORMATION est accessible à l'adresse suivante, en anlgais :
http://www.who.int/druginformation
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WHO DRUG INFORMATION, Volume 22, Number 2
This issue of WHO DRUG INFORMATION opens with a progress report from the
WHO Prequalification Programme for medicinal products, a service
provided by the World Health Organization (WHO) to facilitate access to
medicines that meet international unified standards of quality, safety and
efficacy for HIV/AIDS, malaria, tuberculosis and reproductive
health.
A feature article on International Nonproprietary Names for Monoclonal
Antibodies summarizes the IFPMA proposal presented to the 46th
Consultation on International Nonproprietary Names (INNs) for
Pharmaceutical Substances held at WHO in Geneva in April 2008. The
proposal was developed by the IFPMA (International Federation of
Pharmaceutical Manufacturers & Associations) Biotech Working Group, which
includes twenty companies, two regional and three national
associations located in Europe, Japan and USA.
An article is also included on the Role of the International
Pharmacopoeia in quality assurance and describes the history and related
activities, with a special focus on regulatory aspects and use.
The section on Safety and Efficacy highlights the recent concerns
involving contamination of certain heparin products and follows with
information on signals and reports of adverse drug reactions, with other
news from around the world, including labeling changes. This section 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 Proposed list number 99 of International Nonproprietary
Names (INN).
Access to Medicines
WHO prequalification: progress in 2007 79
Safety and Efficacy Issues
Update on safety of heparin
84
Nicorandil-associated ulceration
85
Topiramate and other drugs causing glaucoma 86
Varenicline: serious psychiatric reactions 86
Montelukast : safety review
88
Neurocognitive effects of chemotherapy 89 New
MMRV vaccine recommendations
89
Oseltamivir label updated with neuropsychiatric warning 90
Ketoconazole tablets: risk of hepatotoxicity 90
Alemtuzumab: infection-related deaths 91
Mycophenolate mofetil: progressive multifocal
leukoencephalopathy 91
Modafinil: serious rash and psychiatric symptoms 92
Moxifloxacin: serious hepatic and skin reactions 92
Rimonabant: depression; psychiatric reactions 93
Exenatide: risk of acute pancreatitis 94
Zanamivir: neuropsychiatric events
94
Inosine ponophosphate dehydrogenase inhibitors:
congenital anomalies 94
Strontium ranelate: life-threatening allergic reactions 95
Lapatinib and hepatoxicity
96
Telbivudine and peripheral neuropathy 96
International Nonproprietary Names
International Nonproprietary Names for monoclonal
antibodies: IFPMA proposal 97
Regulatory Action and News
Dydrogesterone withdrawn for commercial reasons 108
Enoxaparin contamination: batches recalled 109
Recombinant antihemophilic factor approved 110
Rotavirus vaccine approved
111
New version of genetically engineered Factor VIIa approved 111
International Pharmacopoeia
Role of The International Pharmacopoeia in quality
assurance
113
Proposed International Nonproprietary Names: List 99 121