WHO Drug Information articles from June 2006

WHO Drug Information archives from June 2006

Monoclonal antibodies: a special regulatory challenge?(Biomedicines and Vaccines)
June 22, 2006... Use of monoclonal antibodies is an important development in the search for new therapeutic agents. Monoclonal antibody (mAb) technology allows production of large amounts of pure antibodies which are potentially more effective than conventional...

Improving world health through regulation of biologicals.(Biomedicines and Vaccines)
June 22, 2006... On the occasion of the International Conference of Drug Regulatory Authorities (ICDRA) held in Seoul, Republic of Korea, 3-6 April 2006, a pre-meeting was organized on improving world health through regulation of biologicals. Discussion...

Global progress in monitoring immunization adverse events.(Safety and Efficacy Issues)
June 22, 2006... A WHO consultation on Global Monitoring of Adverse Events following Immunization was held from 9 to 10 January 2006 in Geneva. The meeting was held in response to greater political interest in patient safety and the importance of...

Intracranial haemorrhage in patients receiving tipranavir.(Safety and Efficacy Issues)
June 22, 2006... Canada -- The manufacturer of tipranavir (Aptivus[R]) has informed health care professions of important new safety information. Tipranavir co-administered with low-dose ritonavir is indicated for combination antiretroviral treatment of HIV-1...

Infliximab: hepatosplenic T cell lymphoma.(Safety and Efficacy Issues)
June 22, 2006... Canada -- The manufacturers of infliximab (Remicade[R]) have informed health care professionals of important new safety information. Infliximab is a chimeric IgG monoclonal antibody known as a biological response modifier that is directed...

Lamotrigine: increased risk of non-syndromic oral clefts.(Safety and Efficacy Issues)
June 22, 2006... Canada -- The manufacturer of lamotrigine (Lamictal[R]) has informed health care professionals of important new safety information. Emerging data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry suggest an association...

Bisphosphonates: osteonecrosis of the jaw.(Safety and Efficacy Issues)(Clinical report)
June 22, 2006... Australia -- The Australian Adverse Drug Reactions Advisory Committee (ADRAC) has previously drawn attention to the problem of osteonecrosis of the jaw (maxilla or mandible) occurring in the context of treatment with bisphosphonates (1) and...

Enoxaparin dosage in chronic kidney disease.(Safety and Efficacy Issues)
June 22, 2006... Australia -- Although low molecular weight heparins (LMWH) are a convenient and effective alternative to unfractionated heparins, it is important to remember that LMWH, such as enoxaparin, also have associated risks. LMWH have a longer half...

Terbinafine and life-threatening blood dyscrasias.(Safety and Efficacy Issues)
June 22, 2006... Australia -- Oral terbinafine (Lamisil)[R] is indicated for severe ringworm unresponsive to topical treatment and onychomycosis in adults. Prescribers should be aware that there are three serious, albeit rare, reactions associated with oral...

Adverse reactions in children: why report?(Safety and Efficacy Issues)
June 22, 2006... Canada -- Like other patients using health products, children are at risk of adverse reactions (ARs). In 2005, 7.3% of the domestic AR reports received by Health Canada described ARs associated with health products in patients 18 years and...

Hepatitis B reactivation and anti-TNF-alpha agents.(Safety and Efficacy Issues)
June 22, 2006... Singapore -- Three anti-tumour necrosis factor alpha (anti-TNF[alpha]) agents are registered in Singapore--etanercept (Enbrel[R]) adalimumab (Humira[R]) and infliximab (Remicade[R]). These products are indicated for the treatment of rheumatoid...

Dolasetron mesylate and serious cardiovascular reactions.(Safety and Efficacy Issues)
June 22, 2006... Canada -- The label for dolasetron mesylate products has carried warnings about QTc prolongation and the description of serious cardiovascular adverse reactions since approval in 1997. Although dolasetron has never been indicated for use in...

Valproic acid and pancreatitis in a child.(Safety and Efficacy Issues)
June 22, 2006... Malaysia -- The Malaysia Adverse Drug Reactions Advisory Committee (MADRAC) has received a report of a 3 year-old girl who who was suspected to have developed pancreatitis as a result of the use of sodium valproate which was prescribed to...

Safety updates.(Safety and Efficacy Issues)
June 22, 2006... Singapore -- The Health Sciences Agency (HSA) has approved the following package insert changes as aa result of safety updates from January to March 2006. They are also listed at http://www.hsa.gov.sg/cda/ labelchanges. Please note that there...

Concomitant ibuprofen and acetylsalicylic acid.(Safety and Efficacy Issues)
June 22, 2006... United States of America -- Healthcare professionals should be aware of interaction between low dose acetylsalicylic acid/aspririn (81 mg per day) and Ibuprofen which might render acetylsalicylic acid less effective when used for its...

Expert Committee on Drug Dependence: recommendations.(Topics of Current Interest)
June 22, 2006... WHO's Expert Committee on Drug Dependence (ECDD) provides advice to the United Nations Commission on Narcotic Drugs concerning substances controlled under the Single Convention on Narcotic Drugs (1961) and the Convention on Psychotropic...

Lack of essential medicines for children.(Topics of Current Interest)
June 22, 2006... The first international Expert Consultation on Paediatric Essential Medicines, organized by WHO and UNICEF, 9-10 August 2006, has delivered a plan to boost access to essential medicines for children. Ten million children die every year, many of...

Access to new medicines by developing countries.(Topics of Current Interest)
June 22, 2006... In May 2006, the World Health Assembly adopted a resolution that could change the concept of drug research and development and offer greater access to medicines. This urges Member States to make research and development of medicines a public...

Counterfeit taskforce launched.(Topics of Current Interest)
June 22, 2006... The World Health Organization (WHO) has launch a Taskforce to fight a thriving multimillion-dollar illegal trade in counterfeit drugs, vaccines and other medical products. The International Medical Products Anti-Counterfeiting Taskforce...

Fake artesunate warning sheet.(Topics of Current Interest)(Brief article)
June 22, 2006... Fourteen different types of counterfeit artesunate tablets have been identified in South-East Asia labelled as made by Guilin Pharmaceutical Co. Ltd. A warning sheet that lists the types containing small amounts of artesunate, and a new Type 13...

Resolution on counterfeiting.(Topics of Current Interest)
June 22, 2006... The European Parliament has adopted a non-binding resolution calling on the creation of an international convention to fight counterfeiting of medicines. The European Union (EU) is urged to play a key role in the creation of a specific criminal...

Influenza virus vaccines for 2006-2007 northern hemisphere.(Regulatory Action and News)
June 22, 2006... World Health Organization--It is recommended that vaccines to be used in the northern hemisphere 2006-2007 contain the following: * an A/New Caledonia/20/99(H1N1)-like virus; * an A/Wisconsin/67/2005 (H3N2)-like virus. Candidate vaccine...

Trastuzumab approved for primary breast cancer.(Regulatory Action and News)
June 22, 2006... New Zealand--Trastuzumab (Herceptin[R]) has been provisionally approved for the treatment of some women with early stage breast cancer by Medsafe, the Medicines and Medical Devices Safety Authority. Medsafe is the first medicines regulatory...

Emergency contraception over-the-counter.(Regulatory Action and News)
June 22, 2006... United States of America -- The Food and Drug Administration (FDA) has announced approval of Plan B[R], a contraceptive containing 0.75 mg levonorgestrel, as an over-the-counter (OTC) option for women aged t 8 and older. Like other birth...

Ocular Fusarium infections: ReNu MoistureLoc[R] voluntary withdrawal.(Regulatory Action and News)
June 22, 2006... United Kingdom -- An increase in ocular Fusarium infections has occurred in Hong Kong, Singapore and the USA. A root cause for these infections has not been found, but a disproportionate number of those infected used ReNu MoistureLoc[R]....

Saquinavir: withdrawal of soft gel capsule Fortovase[R].(Regulatory Action and News)
June 22, 2006... European Union -- On 20 August 1998 the European Commission issued a marketing authorization for the medicinal product saquinavir (Fortovase[R]), soft gel capsules, intended for the treatment of HIV-1 infected adult patients. Fortovase[R]...

Latest list of prequalified products and manufacturers.(Regulatory Action and News)
June 22, 2006... World Health Organization -- The objective of the Prequalification Programme, is to assess the acceptability in principle of HIV/ AIDS, tuberculosis and malaria medicines and diagnostics for procurement by UN Agencies. The assessment...

Clopidogrel: new medical use.(Regulatory Action and News)(Brief article)
June 22, 2006... United States of America -- The Food and Drug Administration (FDA) has approved the use of clopidogrel bisulfate (Plavix[R]) for patients who have had a type of heart attack called acute ST-segment elevation myocardial infarction (STEMI) and...

Dronedarone: withdrawal of marketing authorization.(Regulatory Action and News)
June 22, 2006... European Union -- The European Medicines Agency (EMEA) has been formally notified of the manufacturer's decision to withdraw the application for a centralized marketing authorization for the medicinal product dronedarone hydrochloride...

MSF issues ninth antiretroviral price list.(Recent Publications, Information and Events)
June 22, 2006... Untangling the Web of Price Reductions. a Pricing Guide for the Purchase of ARVs for Developing Countries was first published by Medecins Sans Frontieres (MSF) in October 2001 in response to the lack of transparent and reliable information...

Progress in HIV / AIDS medicines access.(Recent Publications, Information and Events)
June 22, 2006... The World Health Organization (WHO) continues its work in pharmaceuticals and technologies to promote access to safe, effective medicines and equipment of assured quality for the treatment, diagnosis and monitoring of HIV/AIDS. The Health...

Antiretroviral treatment failure and patient support.(Recent Publications, Information and Events)
June 22, 2006... A new report was presented by the World Health Organization at the Toronto International AIDS Conference held in August 2006. It shows that access to antiretrovirals is only part of the treatment equation. Without targeted patient support, the...

Nanotechnology-based medicinal products.(Recent Publications, Information and Events)(Brief article)
June 22, 2006... The scope of Nanotechnology-based-medicinal products for Human Use reflects current thinking and initiatives taken by the European Medicines Agency (EMEA) following recent developments in development of nanotechnology-based medicinal products....

Public health, innovation and intellectual property rights.(Recent Publications, Information and Events)
June 22, 2006... In May 2003, WHO Member States agreed to set up a body to consider the relationship between intellectual property rights and innovation and their impact on public health. A Commission was established in February 2004 and has now published its...

International Nonproprietary Names for pharmaceutical substances (INN).
June 22, 2006... RECOMMENDED international nonproprietary names: List 56 Notice is hereby given that, in accordance with paragraph 7 of the Procedure for the Selection of Recommended International Nonproprietary Names for Pharmaceutical Substances [Off....