[disponible en anglais seulement http://www.who.int/druginformation CB]
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 21 Number 2
This issue of WHO DRUG INFORMATION provides readers with the complete WHO Model List of Essential Medicines agreed during the Expert Committee meeting held in Geneva in March 2007.
Activities involving neglected tropical diseases are gaining in strength and number, while an open access database has recently been established to facilitate research involving new product development.
The section on Safety and Efficacy gives the latest information on signals and reports of adverse reactions, with other news from around the world, including labeling changes and alerts. This is complemented by Regulatory Action and News which provides the most recent decisions from regulatory authorities, and particularly those having an impact on decision-taking.
International Pharmacopoeia monographs for pharmaceuticals included in the WHO Model List continue to be developed and the latest drafts on artemether/lumefantrine, magnesium sulfate, and paediatric zinc sulfate are proposed for comment.
Finally, many interesting publications and activities are reviewed and the journal concludes with the latest list of Proposed International Nonproprietary Names (INN).
Table of Contents
Safety and Efficacy Issues
Entecavir: not for use in HIV/HBV co-infection 87
Deferasirox: acute renal failure and cytopenias 87
Safety of oseltamivir 87
Fluticasone: reports of behavioural changes 88
Quetiapine: pancreatitis and thrombocytopenia 88
Aprotinin: hypersensitivity reactions and renal dysfunction 89
Metoclopramide in children: extrapyramidal symptoms 90
Drug-eluting stents: to be used with caution 90
Darbepoetin alfa and epoetin alfa: update for non-myeloid malignancies 91
Ayurvedic and Chinese medicines: heavy metals 91
ADHD drugs: cardiovascular and psychiatric events 92
Clozapine can impair motility of the entire GI tract 93
Essential Medicines
15th Model List of Essential Medicines 94
Model List of Essential Medicines, 15th Edition, revised March 2007 95
Regulatory Action and News
Tegaserod: marketing suspension 112
Pergolide: voluntary withdrawal of products 112
Aliskiren approved for hypertension 113
Lapatinib approved for breast cancer 114
Adalimumab approved for Crohn disease114
Rapid test for meningitis cleared for marketing 114
Eculizumab approved for paroxysmal nocturnal haemoglobinuria 115
Access to Medicines
Neglected tropical diseases 116
Open access database for neglected medicines development 116
Consultation Document
International Pharmacopoeia
Artemether and lumefantrine capsules 118
Magnesium sulfate injection 123
Zinc sulfate 124
Paediatric zinc sulfate tablets 125
Paediatric zinc sulfate oral solution 127
Recent Publications, Information and Events
Informed consent for research in resourcepoor settings 129
Lessons learned in home management of malaria 129
Developing drug information centres in India 130
First-in-man clinical trials for high risk products 130
Pakistan Pharmacists Society discussion forum 130
New quality assurance compendium 130
Pharmacological management of human H5N1 infection 131
Proposed International Nonproprietary Names:
List 97 133