WHO Drug Information articles from September 2000

WHO Drug Information archives from September 2000

General Policy Issues.
September 22, 2000... Consumer reporting of adverse drug reactions Effective use of medicines depends on the availability of reliable information. Where adverse reactions and interactions of drugs are concerned, existing systems of adverse drug reaction...

Vaccines and Biomedicines.
September 22, 2000... Quality assurance and safety of biologicals Because of their unique origin, biological products derived from normal or genetically-modified living organisms offer particular challenges concerning requirements for quality, safety and...

General Information.
September 22, 2000... Thirty-second Expert Committee on Drug Dependence The WHO Expert Committee on Drug Dependence fulfils a fundamental role within the framework of the international drug control system of the UN Conventions. The WHO Expert Committee is...

Etanercept: serious heamatological reactions.
September 22, 2000... European Union -- The European Agency for the Evaluation of Medicinal Products (EMEA) has received information of 10 cases of serious blood dyscrasias, some with fatal outcome, in rheumatoid arthritis patients treated with etanercept...

Infliximab: safety restrictions.
September 22, 2000... European Union -- The European Agency for the Evaluation of Medicinal Products (EMEA) has issued a public statement regarding tuberculosis or other opportunistic infections following infliximab (Remicade[R]) therapy. Infliximab is a new...

Phenylpropanolamine withdrawn from drug products.
September 22, 2000... United States of America -- Steps have been taken by the Food and Drug Administration to remove phenylpropanolamine from all products because of the risk of haemorrhagic stroke. Manufacturers have been requested to discontinue marketing...

Labelling revision for phenylpropanolamine.
September 22, 2000... Japan -- The Ministry of Health and Welfare has instructed domestic manufacturers and wholesalers of drugs containing phenylpropanolamine (PPA), a drug linked to haemorrhagic stroke in the United States, to revise the precautions statement of...

Phenylpropanolamine advisory to consumers.
September 22, 2000... Canada -- Health Canada has issued an advisory concerning phenylpropanolamine (PPA) concerning a reported association with haemorrhagic stroke. PPA is widely used as a nasal decongestant in prescription and non-prescription cough and cold,...

Phenylpropanolamine: strengthening of patient information.
September 22, 2000... United Kingdom -- The Committee on Safety of Medicines (CSM) has considered new evidence from the Haemorrhagic Stroke Project. During its meeting on 8 November 2000, it concluded that the evidence of a link between haemorrhagic stroke and...

Levacetylmethadol and cardiac disorders.
September 22, 2000... European Union -- The European Agency for the Evaluation of Medicinal Products (EMEA) has received information on 10 case reports of life-threatening cardiac disorders including ventricular rhythm disorders such as torsades de pointes in...

Bovine-derived materials and vaccines: US recommendations.
September 22, 2000... United States of America -- The Center for Biologics Evaluation and Research (CBER) convened a meeting in July 2000 of the Transmissible Spongiform Encephalopathy Advisory Committee and the Vaccines and Related Biological Products Advisory...

Products containing human albumin.
September 22, 2000... Portugal -- An evaluation carried out by the Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) has concluded that the risk of transmission of variant Creutzfeldt-Jakob...

Stavudine and didanosine: pregnancy advisory.
September 22, 2000... The manufacturer of stavudine (Zerit[R]) and didanosine (Videx[R]) has warned health care professionals that pregnant women may be at increased risk of fatal lactic acidosis when prescribed these HIV drugs with other antiretrovirals. ...

Methysergide and cardiac valvulopathy.
September 22, 2000... Australia -- Methysergide is an ergot alkaloid used in the prophylaxis of migraine. Its most serious known adverse effect is retroperitoneal fibrosis. It has also been reported to be associated with fibrotic changes to other organs including...

Greater control for cisapride.
September 22, 2000... United Arab Emirates -- After studying reports of rare but serious ventricular arrhythmias caused by the gastrointestinal motility drug cisapride, the UAE Ministry of Health has made cisapride a Registered Prescription (RP) drug. An RP drug can...

New combination drug for HIV.
September 22, 2000... United States of America -- The Food and Drug Administration (FDA) has approved Trizivir[R] alone or in combination with other antiretroviral agents, for the treatment of HIV infection in adults and adolescents. Trizivir[R] is a combination of...

Tacrolimus for atopic dermatitis.
September 22, 2000... United States of America -- The Food and Drug Administration has approved a new treatment for eczema, tacrolimus ointment 0.1% and 0.03% for adults and 0.03% for children 2 years and under. It is indicated for patients with moderate to severe...

Letrozole approved for advanced breast cancer.
September 22, 2000... United States of America -- The Food and Drug Administration has approved letrozole (Femara[R]) as a first-line treatment for postmenopausal women with hormone receptor positive or hormone receptor unknown, advanced or metastatic breast cancer....

Alosetron withdrawn.
September 22, 2000... United States of America -- The manufacturer of alosetron (Lotronex[R]), has informed the Food and Drug Administration (FDA) that it has voluntarily withdrawn this product from the market [1]. Alosetron is a prescription medication approved to...

Basiliximab: hypersensitivity reactions.
September 22, 2000... The manufacturer of basiliximab (Simulect[R]), has informed health care providers of 17 cases of severe acute hypersensitivity reactions, including anaphylaxis, occurring in patients following the administration of basiliximab. The onset of...

Budipine: cardiac reactions.
September 22, 2000... Germany -- The manufacturer of the antiParkinson agent, budipine (Parkinsan[R]), has revised the contraindications in the product information to include patients with cardiomyopathy, myocarditis and AV block II and III as well as patients with...

Capecitabine: revised data sheet.
September 22, 2000... The manufacturer of the antineoplastic drug, capecitabine (Xeloda[R]), has informed prescribers of important safety-related changes to the labelling to include contraindications in patients with severe renal impairment. In addition, for...

Benzathine penicillin: fatal mega-unit injections.
September 22, 2000... Zimbabwe -- The Medicines Control Authority has received 3 reports of death associated with benzathine penicillin injections from 3 different manufacturers. Prior to these reports -- from 1993 to 1999 -- the Authority has received only one...

Disulfiram: hepatic reactions.
September 22, 2000... Sweden -- Disulfiram is prescribed as an adjunct in the treatment of chronic alcoholism inhibiting the enzyme, aldehyde dehydrogenase. The combination of alcohol and disulfiram leads to an accumulation of acetaldehyde which induces classic...

Isoniazid and rifampicin: severe skin reactions.
September 22, 2000... Zimbabwe -- The Medicines Control Authority has recently received four adverse reaction reports of burn-like lesions on the whole body and mucosal ulcerations" associated with isoniazid and rifampicin. None of the four patients were taking...

Omeprazole-induced interstitial nephritis.
September 22, 2000... New Zealand -- Acute renal impairment caused by interstitial nephritis is a rare complication of treatment with omeprazole. The New Zealand Centre for Adverse Reaction Monitoring (CARM) has received 7 reports of acute renal failure due to...

Ozagrel sodium: kidney function disorder.
September 22, 2000... Japan -- Ozagrel sodium, a thromboxane synthesis enzyme inhibitor is indicated for the improvement of postoperative cerebrovascular contraction and accompanying cerebral ischaemia and for improvement of motility disturbance due to acute...

Drug information to the public.
September 22, 2000... Japan -- The Health Policy Bureau of the new Ministry of Health, Labour and Welfare plans to create a council responsible for the provision of easy-to-understand information to the general public on indications, adverse reactions, and prices of...

Northern hemisphere influenza vaccine composition.
September 22, 2000... World Health Organization -- The composition for the northern hemisphere influenza season (2001-2002) has been decided and communicated to vaccine manufacturers. It is recommended that the influenza vaccine should contain the following three...

Herbal Medicines.
September 22, 2000... Research and evaluation of traditional and herbal medicines The expanding use of traditional and herbal medicines is gaining recognition globally. Not only do herbal medicines continue to be used in primary health care in developing...

The safety of herbal medicines.
September 22, 2000... The use of herbal medicines poses sensitive challenges to drug regulatory authorities responsible for the safety, efficacy and quality of medicines both nationally and internationally. An informative presentation on these issues was made by the...

Bridging the digital divide.
September 22, 2000... Public and private partners have teamed up to facilitate the flow of health information via the Internet. Major awards for electronic communication in science have been approved for four centres in Africa and five centres in central Asia and...

India publishes ethical guidelines for biomedical research.
September 22, 2000... The Indian Council of Medical Research has issued ethical guidelines for biomedical research on human subjects. The foreword sets the tone of the guidelines by drawing attention to the exciting and awesome breakthroughs in science being...

International Nonproprietary Names for Pharmaceutical Substances (INN).
September 22, 2000... Notice is hereby given that, in accordance with article 3 of the Procedure for the Selection of Recommended International Nonproprietary Names for Pharmaceutical Substances, the names given in the listen the following pages are under...