[e-farmacos] WHO Drug Information vol 20, num 3

["Madurga, Mariano" <mmadurga@agemed.es>]

Estimadas y estimados,

Acaba de salir el num 3 del vol 20 del WHO Drug Information.

Disponible en: 

http://www.who.int/druginformation

Un abrazo,

Mariano Madurga Sanz
Jefe de Servicio de Coordinacion del SEFV
Division de Farmacoepidemiologia y Farmacovigilancia
Agencia Espanhola de Medicamentos y Productos Sanitarios 
E-28022-Madrid
(Espanha)
Correo-e: mmadurga@agemed.es 
Internet: www.agemed.es

WHO DRUG INFORMATION, Volume 20 Number 3  

This issue of WHO DRUG INFORMATION opens with a feature article on the complexities of evaluating monoclonal antibodies and the resulting challenges for regulatory authorities and safety programmes. In the same section is a summary of presentations made during the meeting on Regulation of Biological Medicines held in Seoul prior to the International Conference of Drug Regulatory Authorities (ICDRA).

Other topics focus on access to medicines, the recent European Parliament resolution on counterfeits, and progress made in establishing IMPACT - the international task force on anticounterfeiting.

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 decisions from regulatory authorities, and particularly those having an impact on decision-taking. Volume 20 Number 3 also contains brief summaries of recent publications and information which may be of interest to readers and concludes with Recommended INN List 56.

CONTENTS 

Biomedicines and Vaccines 
Monoclonal antibodies: a special regulatory challenge?  165 
Improving world health through regulation of biologicals        173 

Safety and Efficacy Issues 
Global progress in monitoring immunization adverse events       180 
Intracranial haemorrhage in patients receiving tipranavir       180 
Infliximab: hepatosplenic T cell lymphoma               181 
Lamotrigine: increased risk of non-syndromic oral clefts        181 
Biphosphonates: osteonecrosis of the jaw                181 
Enoxaparin dosage in chronic kidney disease             182 
Terbinafine and life-threatening blood dyscrasias               183 
Adverse reactions in children: why report?              183 
Hepatitis B reactivation and anti-TNF-alpha agents              185 
Dolasetron mesylate and serious cardiovascular reactions        185 
Valproic acid and pancreatitis in a child               185 
Safety updates          186 
Concomitant ibuprofen and acetylsalicylic acid          188 

Topics of Current Interest 
Expert Committee on Drug Dependance: recommendations            190 
Lack of essential medicines for children                191 
Access to new medicines by developing countries         191 
Counterfeit taskforce launched          192 
Fake artesunate warning sheet           193 
Resolution on counterfeiting            193 

Regulatory Action and News 
Influenza virus vaccines for 2006-2007 northern hemisphere      196 
Trastuzumab approved for primary breast cancer          196 
Emergency contraception over-the-counter                197 
Ocular Fusarium infections: ReNu MoistureLoc® voluntary 
    withdrawal          197 
Saquinavir: withdrawal of soft gel capsule Fortovase®           197 
Latest list of prequalified products and manufacturers  198 
Clopidogrel: new medical use            199 
Dronedarone: withdrawal of marketing authorization      199 

Recent Publications, 
Information and Events 
MSF issues ninth antiretroviral price list              200 
Progress in HIV/AIDS medicines access           200 
Antiretroviral treatment failure and patient support            200 
Nanotechnology-based medicinal products         201 
Public health, innovation and intellectual property rights      202 

Recommended International Nonproprietary Names: 
   List 56              203