WHO Drug Information articles from September 2003

WHO Drug Information archives from September 2003

Medical device regulation: a model framework.(Regulatory Challenges)
September 22, 2003... The term "medical devices" covers a vast array of products from simple tongue depressors to magnetic resonance equipment. The intended primary mode of action of a medical device on the human body, in contrast with that of medical products, is...

Maternal use of SSRIs and neonatal effects.(Safety and Efficacy Issues)
September 22, 2003... Maternal use of selective serotonin reuptake inhibitors (SSRIs) during or after pregnancy may result in adverse effects in newborn babies, due to a withdrawal effect following intra-uterine exposure, or a toxic effect from ingestion of an SSRI...

ACE inhibitor, diuretic and NSAID: a dangerous combination.(Safety and Efficacy Issues)
September 22, 2003... The control of hypertension by ACE inhibitors and diuretics and their beneficial effects in heart failure are antagonized by NSAIDs*. Concurrent use of NSAIDs and diuretics is associated with a twofold increase in the risk of hospitalization...

Serious gastrointestinal effects with celecoxib and rofecoxib.(Safety and Efficacy Issues)
September 22, 2003... The Australian Adverse Drug Reactions Advisory Committee (ADRAC) has received a significant number of reports of peptic ulcer (with and without perforation or haemorrhage) and of gastrointestinal (GI) haemorrhage with celecoxib (Celebrex[R])...

Bisphosphonates and ocular disorders.(Safety and Efficacy Issues)
September 22, 2003... Bisphosphonates inhibit bone resorption. Indications for their use vary according to the individual products, but they are used primarily to prevent or treat osteoporosis, Paget disease of bone, tumour-induced hypercalcaemia and conditions...

Fluticasone and adrenal suppression.(Safety and Efficacy Issues)
September 22, 2003... Inhaled corticosteroids are highly effective for the control of asthma and the prevention of exacerbations (1). However, there have recently been several reports worldwide of adrenal insufficiency in adults and children using inhaled...

Adhesion prevention solutions in gynecological procedures.(Safety and Efficacy Issues)
September 22, 2003... Intergel[TM] Adhesion Prevention Solution (0.5% ferric hyaluronate gel) has been indicated in Canada for use as an intraperiteneal instillate for the reduction of adhesiens follewing peritoneal cavity surgery (1). It provides a transient,...

Treatment study for West Nile virus.(Safety and Efficacy Issues)
September 22, 2003... A clinical trial evaluating an experimental treatment for patients infected with West Nile virus (WNV) has begun enrolling volunteers at 36 sites In the USA. This study is part of a larger effort by the National Institutes of Allergy and...

Blue discoloration and death from FD&C Blue No. 1.(Safety and Efficacy Issues)
September 22, 2003... The US Food and Drug Administration (FDA) has advised that several reports of toxicity, including death, have been associated with the use of FD&C Blue No. 1 (Blue 1) in enteral feeding solutions. In these reports, Blue 1 was intended to help...

Atazanavir and tenofovir combination cautioned.(Safety and Efficacy Issues)
September 22, 2003... The manufacturer of atazanavir has informed clinicians of new pharmacokinetic (PK) data concerning coadministration of atazanavir sulfate (Reyataz[R]) with tenofovir disoproxil fumarate (DF) (Viread[R]). Two studies have been conducted to...

Rofecoxib, celecoxib and cardiovascular risk.(Safety and Efficacy issues)
September 22, 2003... In a randomized controlled trial of the efficacy of rofecoxib in rheumatoid arthritis (the VIGOR study) the incidence of myocardial infarction was significantly greater with rofecoxib than with the comparator drug, naproxen (0.4% vs 0.1%) (1)....

Convulsions and blood dyscrasias with mirtazapine.(Safety and Efficacy issues)
September 22, 2003... Mirtazapine (Remeron[R], Avanza[R], Mirtazon[R]), an antidepressant, antagonizes central [alpha.sub.2] adrenoceptors to cause an increase in noradrenaline and serotonin release. It is also a histamine [H.sub.1] receptor antagonist, causing...

Anti-epileptic drugs, pregnancy and fetal malformations.(Safety and Efficacy issues)
September 22, 2003... For seine decades, an association has been recognized between maternal epilepsy and an increased risk of fetal malformation. Although inadequately controlled epilepsy is associated with dangers to mother and fetus, anti-epileptic drugs (AEDs)...

Supplying quality medicines for filariasis elimination.(Aspects of Quality Assurance)
September 22, 2003... Lymphatic filariasis is a disfiguring, disabling disease transmitted by infected mosquitoes. It is caused by threadlike parasitic filarial worms which lodge in the lymphatic system and live for four to six years, producing millions of immature...

Recommended influenza vaccine for 2004 (Southern hemisphere).(Regulatory and Safety Action)
September 22, 2003... World Health Organization--National Authorities are responsible for recommendations regarding the use of influenza vaccine and should approve the specific vaccine viruses used in each country. It is recommended that influenza virus vaccines...

Daclizumab: safety alert.(Regulatory and Safety Action)
September 22, 2003... North America -- Two new warning statements have been added to the prescribing information for daclizumab (Zenapax[R]) indicated for for the prevention of graft rejection. These include increased mortality in a cardiac transplant study and...

Nefazodone discontinued.(Regulatory and Safety Action)
September 22, 2003... Canada -- In consultation with Health Canada, the manufacturer of nefazodone (Serzone-[5HT.sub.2][R]) has decided to discontinue sales of the product from the market in Canada effective 27 November 2003. Nefazodone has been associated with...

Levomethadyl discontinued.(Regulatory and Safety Action)
September 22, 2003... United States of America -- The sale and distribution of levomethadyl hydrochloride acetate (Orlaam[R]) oral solution, 10 mg/mL will be discontinued after the current inventory is depleted in the first quarter of 2004. Since the introduction of...

Daptomycin: new class of antibiotic approved.(Regulatory and Safety Action)
September 22, 2003... United States of America -- The Food and Drug Administration (FDA) has announced the approval of daptomycin (Cubicin[R]) injection for the treatment of complicated skin and skin structure infections, including major abscesses, post-surgical...

Tetrahydrogestrinone: grave risks to health.(Regulatory and Safety Action)
September 22, 2003... United States of America -- Tetrahydrogestrinone (THG) is reportedly used by athletes to improve their performance. The Food and Drug Administration (FDA) has determined that THG is an unapproved new drug and is working with other Federal law...

Coronary stents and thrombosis.(Regulatory and Safety Action)
September 22, 2003... United States of America -- The Food and Drug Administration (FDA) has informed physicians that more than 290 reports of thrombosis (clotting) have occurred one to 30 days after the procedure to implant a Cordis Corporation's Cypher Coronary...

Bicalutamide: do not use in localized prostate cancer.(Regulatory and Safety Action)
September 22, 2003... Canada -- In November 2002, bicalutamide (Casodex[R]) 150 mg, was conditionally approved in Canada for patients with localized prostate cancer inappropriate for surgery or radiation therapy. Approval was based on the promising nature of...

Recombinant antihaemophilic factor: dose monitoring required.(Regulatory and Safety Action)
September 22, 2003... Canada -- Recombinant antihaemophilic factor [BDDrFVIII] (ReFacto[R]) has been licensed in Canada since 2002, and is indicated for the control and prevention of haemorrhagic episodes and for routine and surgical prophylaxis in patients with...

Nimesulide-containing products reevaluated.(Regulatory and Safety Action)
September 22, 2003... European Union -- Nimesulide, is a COX-2 inhibitor first launched in Italy in 1985. Since then, it has been marketed in about 50 countries throughout the world. Reports of adverse drug reactions, including hepatic reactions and a report of...

Memantine approved for Alzheimer disease.(Regulatory and Safety Action)
September 22, 2003... United States of America -- The Food and Drug Administration (FDA) has approved memantine (Namenda[R]), for the treatment of moderate to severe Alzheimer disease. Alzheimer disease is a degenerative condition affecting memory, judgment and...

Virologic non-response in more HIV combinations.(Regulatory and Safety Action)
September 22, 2003... Spain -- Lamivudine (Epivir[R]) and didanosine (Videx[R]) in combination with tenofovir (Viread[TM]), should not be used as a triple antiretroviral therapy when considering a new treatment regimen for naive or pre-treated HIV-1 infected...

Placebo or active control? Either, as long as it is in the patient's interest *.(Personal Perspectives)
September 22, 2003... The appropriate use of placebo in controlled clinical trials is still debated. This article briefly reviews different conditions of applicability of the placebo dilemma in the light of patients' interests and needs. We also test out assumptions...

WHO review of NICE in the United Kingdom.(Current Topics)
September 22, 2003... The National Institute of Clinical Excellence (NICE) is responsible for providing guidance to the National Health Service in England and Wales on the clinical-and cost-effectiveness of medicines and medical technologies. In 2002, NICE...

New advice on hormone replacement therapy.(Current Topics)
September 22, 2003... The Million Women Study has been carried out within the United Kingdom and involves around one million women aged 50 years of age and over. The main focus of the study relates to the effects of hormone replacement therapy use, but the large...

Direct-to-consumer advertising and patients.(Current Topics)
September 22, 2003... Direct-to-consumer advertising (DTCA) of prescription drugs has increased rapidly in the United States during the last decade, yet little is known about its effects on prescribing decisions in primary care. From 1996 to 2000, spending on...

Action against counterfeit medicines in Asia and Africa.(Current Topics)
September 22, 2003... The World Health Organization (WHO) has launched an action plan against substandard and counterfeit medicines in six countries from the Greater Mekong sub-region. The plan follows similar initiatives begun in Africa and will continue to expand...

Neglected diseases.(Essential Medicines)
September 22, 2003... The newly created Drugs for Neglected Diseases Initiative (DNDi) plans to spend around $250 million over the next 12 years to develop treatments to combat three killer diseases threatening a combined 350 million people every year: Chagas...

International nonproprietary names for pharmaceutical substances (INN).
September 22, 2003... RECOMMENDED International Nonproprietary Names: List 50 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 Rec....