WHO Drug Information articles from June 2002

WHO Drug Information archives from June 2002

Drug and therapeutics committees: a Swedish experience. (Feature Article).
June 22, 2002... The development of drug and therapeutics committees (DTCs) in hospitals and for primary health care varies markedly from one country to another within Europe (1) but has been particularly strong in the Nordic countries. Since 1997, Swedish law...

Recommendations from the Tenth International Conference of Drug Regulatory Authorities. (Current Topics).
June 22, 2002... Herbal medicines 1. Member States, together with WHO, should define criteria and standards for herbal medicines, health or functional foods, and dietary supplements. WHO should continue to develop guidelines on the assessment of safety,...

The Parenteral Society.
June 22, 2002... The Parenteral Society is a non-profit organization established to promote and advance the practice and science of parenteral drug therapy in the interests of public health and to preserve and improve the integrity and standards of the...

Adverse reactions to natural health products. (Safety Information).
June 22, 2002... Over 50% of Canadians now use natural health products in the form of traditional herbal products, vitamin and mineral supplements, traditional Chinese, Ayurvedic and other medicines and homeopathic preparations. However, there seems to be an...

Leflunomide: haematologic, hepatic and respiratory reactions. (Safety Information).
June 22, 2002... Treatment of rheumatoid arthritis has shifted toward earlier and more aggressive therapy with disease-modifying antirheumatic drugs (DMARDs) (1, 2). Leflunomide (Arava[R]), a newer immunomodulatory DMARD, is indicated for the treatment of...

Herbal mixture and palpitations. (Safety Information).
June 22, 2002... A 30-year-old man who had taken Aphrodite[R] tablets (a herbal mixture of dry extracts of Tribulus terrestris (40 mg), Cinnamomum zeylanicum (11 mg), Zingiber officinal (12 mg) and Crocus sativus (3 mg)) for his impotence problem (one tablet...

Indapamide and hyponatraemia. (Safety Information).
June 22, 2002... An article recently published in the Medical Journal of Australia describes hyponatraemia in association with the non-thiazide diuretic, indapamide. Marketed in the mid-1980s in Australia, indapamide is the most commonly reported cause of...

Epoetin alfa: pure red cell aplasia. (Regulatory and Safety Action).
June 22, 2002... United Kingdom -- Epoetin alfa (Eprex[R]) is indicated for the treatment of anaemia associated with chronic renal failure, cancer chemotherapy, autologous blood donation, and during major elective orthopaedic surgery. There have been 40...

Ergot-derived dopamine receptor agonists: fibrotic reactions. (Regulatory and Safety Action).
June 22, 2002... United Kingdom -- Pergolide, bromocriptine, cabergoline, and isuride are ergot-derived dopamine receptor agonists indicated for the management of Parkinson's disease. Fibrotic reactions are recognized adverse events of ergot derivatives. ...

Buprenorphine approved for opiate dependence. (Regulatory and Safety Action).
June 22, 2002... United States of America -- The Food and Drug Administration has approved buprenorphine hydrochloride (Subutex[R]) and buprenorphine hydrochloride and naloxone hydrochloride (Suboxone[R]), for the treatment of opiate dependence. These products...

Human tissue recalled. (Regulatory and Safety Action).
June 22, 2002... United States of America -- The Food and Drug Administration has ordered Cryolife Inc. to recall distributed human tissue processed since 3 October 2001, since the FDA has determined that Cryolife cannot ensure that the tissue is free from...

Lepirudin and fatal anaphylactic reactions. (Regulatory and Safety Action).
June 22, 2002... European Union -- The European Medicines Evaluation Agency (EMEA) has been informed of 7 reports of severe anaphylactic reactions in patients receiving lepirudin (Refludan[R]). In 6 of these cases, the reaction occurred after re-exposure and 5...

Valdecoxib: new warnings. (Regulatory and Safety Action).
June 22, 2002... United States of America -- The Food and Drug Administration, together with the manufacturer of valdecoxib (Bextra[R]) are advising health care professionals about new warnings and information in the product labelling. Valdecoxib is a drug...

Parecoxib/valdecoxib: serious hypersensitivity reactions. (Regulatory and Safety Action).
June 22, 2002... European Union -- The European Medicines Evaluation Agency (EMEA) has received information on reports of serious hypersensitivity reactions (anaphylaxis and angio-oedema) and serious skin reactions (Stevens-Johnson syndrome, toxic epidermal...

Mefloquine labelling strengthened. (Regulatory and Safety Action).
June 22, 2002... United States of America -- Healthcare professionals have been notified that mefloquine hydrochloride (Lariam[R]) tablets are contraindicated in patients with known hypersensitivity to mefloquine or related compounds. It should not be...

Glucowatch for diabetes. (Regulatory and Safety Action).
June 22, 2002... United States of America -- The Food and Drug Administration (FDA) has approved a wrist-watch-like glucose monitoring device for use by children and adolescents with diabetes. The device, which was approved for adult use in March 2001, provides...

Generic omeprazole approved. (Regulatory and Safety Action).
June 22, 2002... United States of America -- The Food and Drug Administration has approved 10 and 20 mg omeprazole delayed-release capsules for the treatment of certain gastro-intestinal conditions. The generic drug is identical to the brand name drug in dosage...

Oxaliplatin for colorectal cancer. (Regulatory and Safety Action).
June 22, 2002... United States of America -- The Food and Drug Administration has approved oxaliplatin injection (Eloxatin[R]) for use in combination with infusional 5-fluorouracil and leucovorin for the treatment of patients with colorectal cancer whose...

Ergotamine and ischaemia. (Regulatory and Safety Action).
June 22, 2002... United States of America -- Recent changes have been announced to the prescribing information for ergotamine tartrate and caffeine (Cafergot[R]) suppositories arid tablets, which include a new warning on interactions with potent CYP 3A4...

Acetylsalicylic acid and Reye's syndrome. (Regulatory and Safety Action).
June 22, 2002... United Kingdom -- Reyes syndrome is a very rare but often fatal disease characterized by encephalopathy and fatty degeneration of the liver. It has mostly affected children aged less than 5 years but also occurs in older children and teenagers....

Sertraline interactions. (Regulatory and Safety Action).
June 22, 2002... United States of America -- A change in the prescribing information for sertraline hydrochloride tablets and oral concentrate (Zoloft[R]) has been announced by the manufacturer. This change was made at the request of the Food and Drug...

Inhaled corticosteroids and adrenal suppression. (Regulatory and Safety Action).
June 22, 2002... United Kingdom -- The Committee on Safety of Medicines (CSM) has reminded prescribers that adrenal suppression is a well-established adverse reaction of all inhaled corticosteroids. There have been rare reports of adrenal suppression leading to...

Re-introduction of urokinase. (Regulatory and Safety Action).
June 22, 2002... United States of America -- The Food and Drug Administration recently approved the re-introduction of urokinase (Abbokinase[R]) onto the market. Urokinase has been used for more than 20 years by an estimated four million patients. As a...

Ezetimibe approved for cholesterol-lowering. (Regulatory and Safety Action).
June 22, 2002... United States of America -- The Food and Drug Administration has approved ezetimibe (Zetia[R]), a new class of lipid-lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols. Ezetimibe...

A historical overview of the ATC/DDD methodology. (ATC/DDD Classification).
June 22, 2002... Marit Ronning, WHO Collaborating Centre for Drug Statistics Methodology, Norway Drug utilization research has attracted increased attention since its early beginnings in the 1960s. A breakthrough study on drug consumption during the period...

Drug utilization statistics and health policy. (ATC/DDD Classification).
June 22, 2002... Anne Kari Lande Hasle, Secretary General, Norwegian Ministry of Health Drug utilization statistics are an indispensable tool to fulfil goals outlined in health policy. Pharmaceuticals are recognized as playing a major role in maintaining...

Trends in drug utilization research in developing countries. (ATC/DDD Classification).
June 22, 2002... Hans V. Hogerzeil, Policy, Access and Rational Use, Department of Essential Drugs and Medicines Policy, World Health Organization The price of essential medicines is growing. For example, gonorrhoea is increasingly resistant to penicillin:...

Drug utilization data constraints in developing countries. (ATC/DDD Classification).
June 22, 2002... Tariq Iqbal Bhutta, Professor of Paediatrics, Nishtar Medical College, Pakistan Private expenditure on pharmaceuticals in developing countries typically accounts for 50-90% of all spending on drugs. Even for rural populations and the urban...

The future of ATC/DDD and drug utilization research. (ATC/DDD Classification).
June 22, 2002... D. J. Birkett, Professor and Head, Department of Cilnical Pharmacology, Flinders University and Flinders Medical Centre, Adelaide, Australia and Chair, WHO International Working Group for Drug Statistics Methodology The ATC/DDD drug...

International ethical guidelines for biomedical research involving human subjects. (Recent Publications and Sources of Information).
June 22, 2002... This is the third in the series of international ethical guidelines for biomedical research involving human subjects issued by the Council for International Organizations of Medical Sciences (CIOMS) since 1982. Its scope and preparation reflect...

Surveying and Evaluating Ethical Review Practices. (Recent Publications and Sources of Information).
June 22, 2002... Ethical review provides essential guidance on conducting research and protection of trial subjects. The purpose of Surveying and Evaluating Ethical Review Practices is to facilitate and support procedures for quality and transparency in ethical...

The importance of pharmacovigilance. (Recent Publications and Sources of Information).
June 22, 2002... This document sets out to present the case for the importance of pharmacovigilance, to record its growth and potential as a discipline within medical science, and to describe its impact on patient welfare and public health. It presents a...

Effective drug regulation. (Recent Publications and Sources of Information).
June 22, 2002... Drugs play a crucial role in saving lives, restoring health and preventing diseases and epidemics. But they also need to be safe, efficacious, of good quality and used rationally. Their production, import, export, storage, supply and...

Dialogue in pharmacovigilance. (Recent Publications and Sources of Information).
June 22, 2002... In 1997, the Verona Initiative aimed to improve communication of drug safety information to the benefit of patients, health professionals, drug regulators, the pharmaceutical industry, educators, researchers, the media and legal profession. ...

Good storage practices. (Recent Publications and Sources of Information).
June 22, 2002... The Guide to Good Storage Practices for Pharmaceuticals was approved at the Thirty-seventh meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations held on 22-26 October 2001 in Geneva. The guide is intended for...