WHO Drug Information articles from January 2005

WHO Drug Information archives from January 2005

Pharmacogenetics: towards improving treatment with medicines.(Current Topics)
January 1, 2005... Increasingly, sponsors of new drugs are integrating pharmacogenetics in their drug development programmes. The outcome of this integration will present challenges to the traditional paradigms for drug development, regulatory evaluation of...

The role of pharmacovigilance in medicines safety.(Safety and Efficacy Issues)
January 1, 2005... Modern medicines have changed the way in which diseases are managed and administered. Despite obvious benefits, evidence continues to accrue that adverse reactions to medicines are a common--and often preventable--cause of illness, disability...

National Centres discuss new safety monitoring methods.(Safety and Efficacy Issues)
January 1, 2005... The Twenty-seventh meeting of National Centres participating in the WHO Programme for International Drug Monitoring took place in Dublin, Ireland, in October 2004. The meeting focused on identification of new methods of pharmacovigilance,...

Signalling and safety problems.(Safety and Efficacy Issues)
January 1, 2005... One of the most important tasks of the WHO Programme for International Drug Monitoring is to identify signals of drug safety problems as early as possible. The WHO database, which is maintained by the WHO Collaborating Centre for...

Third meeting of the Signal Review Panel.(Safety and Efficacy Issues)
January 1, 2005... On 13 and 14 December 2004, 25 members of the Signal Review Panel met together in Uppsala, Sweden in order to exchange experiences on their work and to learn how to make best use of the information in the WHO database. Discussions focused on...

COX-2 inhibitors: overview.(Safety and Efficacy)
January 1, 2005... On 30 September 2004, Merck & Co., Inc. announced a voluntary withdrawal of rofecoxib (Vioxx[R]) from the worldwide market due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients on...

Telithromycin and warfarin: suspected interaction.(Safety and Efficacy Issues)
January 1, 2005... Telithromycin (Ketek[R]) is a novel antimicrobial that belongs to a new chemical family, the ketolides (1). Ketolides are recent additions to the macrolide-lincosamide streptogramin class and are designed to treat macrolide-resistant...

Penicillin: information strengthened.(Safety and Efficacy Issues)(Brief Article)
January 1, 2005... The manufacturer of penicillin G benzathine and penicillin G procaine (Bicillin[R]) products has advised of important labelling changes to ensure that these products are used and administered appropriately. Penicillin G benzathine...

Linezolid and neuropathy.(Safety and Efficacy Issues)
January 1, 2005... Linezolid (Zyvoxam[R]), a synthetic antibacterial agent in a new class of antibiotics, the oxazolidinones, has been marketed in Canada since 2001 (1). Linezolid is active against methicillin-and vancomycin-resistant Gram-positive...

Ceftriaxone and immune haemolytic anaemia in children.(Safety and Efficacy Issues)
January 1, 2005... Ceftriaxone (Rocephin[R]), marketed in Canada since 31 December 1987, is a third-generation cefalosporin indicated for the treatment of susceptible strains of bacteria, as well as for prophylaxis against infections in patients undergoing...

Ethinylestradiol/cyproterone: increased risk of thrombosis.(Safety and Efficacy Issuesv)(Brief Article)
January 1, 2005... The Norwegian Medicines Control Agency (NMCA) has issued a reminder that ethinylestradiol/cyproterone (Diane[R]) is associated with an increased risk of thrombosis. The NMCA has received 26 reports of adverse reactions associated with...

Influenza virus vaccine: interactions.(Safety and Efficacy Issues)(Brief Article)
January 1, 2005... Prescribers are advised to be alert for signs of toxicity following influenza vaccination in patients receiving anti-epileptic drugs or warfarin. Medsafe, New Zealand, notes that, in addition to published reports of warfarin, phenytoin and...

Rosiglitazone and pioglitazone: dangers of off-label use.(Safety and Efficacy Issues)(Brief Article)
January 1, 2005... Rosiglitazone and pioglitazone are contraindicated in combination with insulin and in patients with cardiac failure or a history of cardiac failure Evidence from United Kingdom reports and usage data indicate that rosiglitazone and...

Naproxen and celecoxib suspended in Alzheimer prevention trial.(Safety and Efficacy Issues)(Brief Article)
January 1, 2005... The National Institutes of Health (NIH) has announced that investigators have suspended the use of two drugs, naproxen (220 mg twice a day) and celecoxib (200 mg twice a day), in a large, three-arm, national Alzheimer disease prevention trial...

Heparin contraindicated in severe renal impairment.(Safety and Efficacy Issues)(Brief Article)
January 1, 2005... Monitoring anti-factor Xa activity may be helpful in patients receiving low molecular weight heparins (LMWH) who are at risk of bleeding or are actively bleeding. Bemiparin, certoparin, dalteparin, enoxaparin, reviparin and tinzaparin...

Flucloxacillin: serious hepatic disorders.(Safety and Efficacy Issues)(Brief Article)
January 1, 2005... Flucloxacillin treatment is very rarely associated with an increased risk of hepatic disorders, namely, hepatitis and cholestatic jaundice. In some patients, almost always those with serious underlying disease, these adverse reactions have...

Bevacizumab and arterial thromboembolic events.(Safety and Efficacy Issues)(Brief Article)
January 1, 2005... The manufacturer of bevacizumab (Avastin[R]) has drawn attention to an increased risk of arterial thremboembolic events associated with the use of bevacizumab in combination with chemotherapy. These events included cerebral infarction,...

Amiodarone toxicity concerns.(Safety and Efficacy Issues)
January 1, 2005... The US Food and Drug Administration (FDA) has required pharmacists and other health care professionals who dispense medication to distribute Medication Guides to patients for certain products, including amiodarone tablets. Amiodarone HCI...

Darbepoetin alfa: adverse outcomes.(Safety and Efficacy Issues)(Brief Article)
January 1, 2005... Darbepoetin alfa (Aranesp[R]) is indicated for the treatment of chemotherapy-induced anaemia in patients with nonmyeloid malignancies. The manufacturer has updated the safety information to reflect results from two recent investigational...

Latest developments in biological standardization.(Vaccines and Biomedicines)
January 1, 2005... The WHO Expert Committee on Biological Standardization met in Geneva from 15 to 18 November 2004 to establish biological reference standards (International Standards), guidance on production and quality control of biological products, and to...

Northern hemisphere influenza vaccine composition 2005/2006.(Regulatory Action)(Brief Article)
January 1, 2005... World Health Organization--The following influenza virus vaccine composition has been recommended for the forthcoming winter in the northern hemisphere. * an A/New Caledonia/20/99(H1N1)-like virus; * an A/California/7/2004(H3N2)-like...

Valdecoxib: severe skin reactions and cardiovascular risk.(Regulatory Action)(Brief Article)
January 1, 2005... United States of America -- The Food and Drug Administration (FDA) has announced important new information on side effects associated with the use of valdecoxib (Bextra[R]), a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID) which...

COX-2 inhibitors: review plans.(Regulatory Action)(Brief Article)
January 1, 2005... European Union--Following the worldwide withdrawal of rofecoxib (Vioxx), the European Medicines Agency (EMEA) has been asked by the European Commission to conduct a review of all cyclo-oxygenase-2 (COX-2) inhibitor medicines. The Agency's...

Co-proxamol products withdrawn.(Regulatory Action)(Brief Article)
January 1, 2005... United Kingdom -- The Committee on Safety of Medicines (CSM) has recently reviewed the risks and benefits of co-proxamol (paracetamol/ dextropropoxyphene). The efficacy of co-proxamol is poorly established and the risk of toxicity in...

Cisapride licences voluntarily cancelled.(Regulatory Action)(Brief Article)
January 1, 2005... United Kingdom -- The marketing authorizations for cisapride-containing products were suspended in July 2000, following advice from the Committee on Safety of Medicines (CSM), due to the risk of cardiac side effects. CSM advised that the...

Tentative approval for generic co-packaged antiretrovirals.(Regulatory Action)(Brief Article)
January 1, 2005... United States of America -- The Food and Drug Administration (FDA) has announced the tentative approval of a co-packaged antiretroviral drug regimen manufactured in South Africa for the treatment of HIV-1 infection in adults. The agency's...

Natalizumab approved for multiple sclerosis.(Regulatory Action)(Brief Article)
January 1, 2005... United States of America -- The Food and Drug Administration (FDA) has licensed a new biologic approach to treat patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of symptom flare-ups or exacerbations of the...

Pegaptanib for age-related macular degeneration.(Regulatory Action)(Brief Article)
January 1, 2005... United States of America -- The Food and Drug Administration (FDA) has approved pegaptanib sodium injection (Macugen[R]), a new therapy to slow vision loss in people with the eye disease neovascular (wet) age-related macular degeneration...

Amphetamine salts suspended.(Regulatory Action)
January 1, 2005... Canada -- Health Canada has suspended marketing of amphetamine salts (Adderall XR[R]) for attention deficit hyperactivity disorder (ADHD) with effect 9 February 2005. The decision to withdraw amphetamine salts is founded on very rare,...

Tolcapone: return to market.(Regulatory Action)
January 1, 2005... United Kingdom -- Tolcapone (Tasmar[R]) is a catechol-O-methyltransferase (COMT)inhibitor medicine developed for use in Parkinson disease. In February 1999, the Committee on Safety of Medicines reported the withdrawal of tolcapone...

Patient reporting and public access to safety data.(Regulatory Action)(published data on drug safety)(Brief Article)
January 1, 2005... United Kingdom -- Patients and researchers will be able to access data on the safety of different medicines as a move to further improve the drug side effect reporting system--the Yellow Card Scheme--used to monitor the safety of medicines in...

Australia and Canada agree mutual recognition.(Regulatory Action)(Brief Article)
January 1, 2005... The Governments of Australia and Canada have signed a Mutual Recognition Agreement (MRA) that enables both countries to accept each other's good manufacturing practice (GMP) audits and inspection of the makers of prescription and over the...

Didanosine-tenofovir interaction: safety concerns.(Regulatory Action)(Brief Article)
January 1, 2005... France -- The Agency for Health Products Safety (AFSSAPS), in collaboration with the European Medicines Agency (EMEA), has carried out a review of available data with regard to reporting of increased reactions and lack of efficacy following...

Prequalification of medicines.
January 1, 2005... Improving medicines quality through prequalification WHO, UNICEF and other organizations are involved in the procurement of pharmaceutical products for use in public health programmes, such as those to combat HIV/AIDS, malaria and...

ATC/DDD classification (final).(anatomical therapeutic chemical)(defined daily doses)
January 1, 2005... ATC/DDD Classification (Final) The following final anatomical therapeutic chemical (ATC) classifications and defined daily doses (DDDs) were agreed at a meeting of the WHO International Working Group for Drug Statistics Methodology...

ATC/DDD classification (temporary).(anatomical therapeutic chemical)(defined daily doses)
January 1, 2005... ATC/DDD Classification (temporary) The following anatomical therapeutic chemical (ATC) classifications and defined daily doses (DDDs) were agreed at a meeting of the WHO International Working Group for Drug Statistics Methodology which...

The international pharmacopoeia.
January 1, 2005... Monographs for antiretrovirals Within the framework of the Procurement, Quality and Sourcing Project for HIV, Tuberculosis and Malaria (http://www.who.int/prequal), The International Pharmacopoeia is collaborating with manufacturers,...

International Nonproprietary Names for pharmaceutical substances (INN).
January 1, 2005... RECOMMENDED International Nonproprietary Names: List 53 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....