WHO Drug Information articles from January 2002

WHO Drug Information archives from January 2002

International reference materials for Creutzfeldt-Jakob disease. (Vaccines and Biomedicines).
January 1, 2002... Transmissible spongiform encephalopathies (TSEs) include bovine spongiform encephalopathy (BSE) in cattle, scrapie in sheep, and Creutzfeldt-Jakob disease (CJD) in humans. TSEs are characterized by spongiform degeneration of the brain and the...

WHO position on rabies vaccine. (Vaccines and Biomedicines).
January 1, 2002... Rabies is a viral zoonoses carried by carnivores and many bat species. Globally, in terms of human disease, dogs represent the most important reservoir of infection. More than 2.5 billion people live in regions where rabies is endemic and it is...

WHO international drug monitoring: cerivastatin and gemfibrozil. (Safety Information).
January 1, 2002... Cerivastatin was first approved for use in the United Kingdom in 1997 and was authorized in all European Union countries through the mutual recognition procedure. Subsequently, it was approved for use in at least 16 other countries throughout...

International Conference on Harmonization (ICH): pharmacovigilance activities. (Safety Information).
January 1, 2002... The International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) was established in 1990 to improve the harmonization of developing and registering new medicinal products in...

The COX-2 inhibitors. (Safety Information).
January 1, 2002... COX-2 inhibitors were initially heralded as a breakthrough class of drugs. However, concerns have been expressed about cardiovascular toxicity (1). The issue has potential implications for physicians and patients far beyond this class of drugs....

Amiodarone and pulmonary toxicity. (Safety Information).
January 1, 2002... Amiodarone (Aratac[R], Cardinorm[R], Cordarone X[R] is an anti-arrythmic agent for the treatment of severe cardiac arrhythmia. The Australian Adverse Reactions Advisory Committee (ADRAC) regularly receives reports of suspected adverse reactions...

Alendronate: link with pancreatitis? (Safety Information).
January 1, 2002... Six case reports of pancreatitis associated with alendronic acid have been received by the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) between December 1995 and August 2001. However, it is difficult to establish a causal...

Endocrinotoxicity induced by Coriandrum sativa: a case report. (Safety Information).
January 1, 2002... Ebrahim Zabihi and Mohammad Abdollahi, Drug and Poisoning Information Center (DPIC), Food and Drug Organization, Ministry of Health & Medical Education, Islamic Republic of Iran A 28 year old woman had taken an extract of Coriandrum sativa...

Haemolysis after consumption of Viola tricolor. (Safety Information).
January 1, 2002... Yasna Behmanesh and Mohammad Abdollahi, Drug and Poisoning Information Center (DPIC), Food and Drug Organization, Ministry of Health & Medical Education, Islamic Republic of Iran A case of hemolysis caused by ingestion of watery extraction...

Lipodystrophy syndrome under-reported. (Safety Information).
January 1, 2002... Antiretroviral therapy (ART)-related lipodystrophy syndrome is highly under-reported in Canada (1). The case definition of lipodystrophy syndrome is described as at least one metabolic abnormality and at least one clinical feature, in addition...

Progress in pharmacogenetics and pharmacogenomics *. (Current Topics).
January 1, 2002... Recent progress in unravelling the secrets of the human genome has led to increased knowledge of genetics in many fields of medicine and supports the promising development of two new branches of science -- pharmacogenetics and pharmacogenomics....

Internet sales and reimbursement by insurance companies. (Current Topics).
January 1, 2002... A Bavarian health insurance company has recently set up a contract with a Dutch internet pharmacy shop and has advised its 1.8 million members to order cheaper drugs via the internet. This would enable the company to reimburse prescriptions at...

Nevirapine: comments on HIVNET 012 from the manufacturer. (Current Topics).
January 1, 2002... Questions have been raised regarding reporting and documentation in a study conducted in Uganda for prevention of the transmission of HIV from mother-to-child during birth, called HIVNET 012. The study, sponsored by the National Institute of...

Review of HIVNET 012. (Current Topics).
January 1, 2002... Since 1997, funding from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), supported a trial known as HIVNET 012, conducted by co-investigators at Makerere University in Kampala, Uganda, and...

Mother to child transmission of HIV: WHO statement. (Current Topics).
January 1, 2002... As stated, the manuacturer of nevirapine has requested the Food and Drug Administration to withdraw the NDA status for the mother-to-child transmission (MTCT) indication of nevirapine. The World Health Organization and UNAIDS continue to...

Enoxaparin sodium Injection: new safety warnings. (Regulatory and Safety Action).
January 1, 2002... United States of America -- The manufacturer of enoxaparin sodium Injection (Lovenox[R]) has made the following additions to the warnings and precautions sections of the prescribing information. In the warnings section, the following...

Ziprasidone hydrochloride: labelling clarifications. (Regulatory and Safety Action).
January 1, 2002... United States of America -- The manufacturer of ziprasidone HCI capsules (Geodon[R]) has circulated a letter to inform healthcare professionals about clarifications to the labelling. Ziprasidone capsules were approved on 5 February 2001. Since...

Kava kava products and potential liver injury. (Regulatory and Safety Action).
January 1, 2002... United States of America -- The Food and Drug Administration has circulated a letter to health care professionals and has advised consumers concerning the potential risk of severe liver injury and rare hepatic failure associated with use of...

Kava kava: investigations into liver injury. (Regulatory and Safety Action).
January 1, 2002... New Zealand, Ireland, Canada -- Further to precautionary warnings issued by the regulatory authorities in Germany, Switzerland, UK and USA the following actions have been recorded on the use of Kava. 16 January 2002: The New Zealand...

Rofecoxib interaction with warfarin. (Regulatory and Safety Action).
January 1, 2002... Australia -- The Australian Drug Reactions Advisory Committee (ADRAC) has previously published a report on the interaction between celecoxib and warfarin (1). It now appears that rofecoxib (Vioxx[R]) and warfarin may also sometimes interact to...

Zolpidem and neurological reactions. (Regulatory and Safety Action).
January 1, 2002... Australia -- Zolpidem (Stilnox[R]) was marketed in Australia in late 2000 for the short-term treatment of insomnia. It is structurally unrelated to the benzodiazepines, but has a similar pharmacological action. In 2001, the Australian Drug...

Paroxetine: severe withdrawal symptoms. (Regulatory and Safety Action).
January 1, 2002... United States of America -- The Food and Drug Administration has published a product warning for paroxetine regarding severe withdrawal symptoms of the kind that could lead to dependence. Withdrawal symptoms such as bad dreams, paraesthesia and...

Hua Fo: unknown substance. (Regulatory and Safety Action).
January 1, 2002... Canada -- Health Canada is warning consumers not to use Hua Fo tablets after they were found to contain an unauthorized substance similar, but not identical to, sildenafil. Sildenafil is a prescription drug approved for male erectile...

Sibutramine safety review. (Regulatory and Safety Action).
January 1, 2002... Canada/Italy/European Union -- In light of recent international regulatory action and numerous reports of adverse reactions in Canada and elsewhere, Health Canada is conducting a safety review of the prescription drug Meridia[R] (sibutramine)....

Cyproterone with ethinylestradiol: risk of venous thromboembolism. (Regulatory and Safety Action).
January 1, 2002... New Zealand -- Cyproterone-containing estrogen pills are used to treat androgen-dependent diseases and polycystic ovary syndrome. They also provide oral contraception. In a letter to doctors, midwives and pharmacists, the Medicines Adverse...

Alfa interferons: labelling change. (Regulatory and Safety Action).
January 1, 2002... United States of America -- The manufacturer of interferon alfa 2b (Intron A[R]) has issued a letter to health professionals informing them of safety related labelling changes to the product information for alfa interferons. The change includes...

Nefazodone: rare cases of liver failure. (Regulatory and Safety Action).
January 1, 2002... United States of America - Due to reports of rare cases of liver faiiure leading to transplant and/or death, a black box warning has been added to the product information for nefazodone (Serzone(r)). The warning is based on postmarketing...

Acarbose, zafirlukast and vincristine: revised precautions. (Regulatory and Safety Action).
January 1, 2002... Japan -- The Ministry of Health, Welfare and Labour has ruled that the package inserts for acarbose, zafirlukast and vincristine sulfate should be appropriately revised to reflect the serious adverse drug reactions (ADRs) being reported with...

Clozapine and myocarditis. (Regulatory and Safety Action).
January 1, 2002... Post marketing surveillance data from Australia, Canada, United Kingdom, and United States of America that employ haematological monitoring of clozapine-treated patients has revealed 15 reports of myocarditis with 5 fatalities in 8000...

Methotrexate: interactions. (Regulatory and Safety Action).
January 1, 2002... India -- A variety of adverse reactions and drug interactions recently reported in association with methotrexate have prompted the revision of prescribing and treatment indications. Skin and soft tissue necrosis has been reported when...

Stavudine: neuromuscular weakness. (Regulatory and Safety Action).
January 1, 2002... Canada/United States of America -- A 'Dear Healthcare Professional' letter has been issued by the manufacturer of stavudine (Zerit[R]) advising that reports have been received of rare occurrences of rapidly ascending neuromuscular weakness,...

Recommended influenza virus vaccine composition. (Regulatory and Safety Action).
January 1, 2002... World Health Organization -- It is recommended that the influenza virus vaccines for the 2002-2003 northern hemisphere winter season contain: * an A/New Caledonia 20/99 (H1N1)-like virus * an A/moscow/10/99 (H3N2)-like virus (such as...

Sodium phosphate oral solution: electrolyte balance disturbance. (Regulatory and Safety Action).
January 1, 2002... Canada -- Sodium phosphate oral solution has been marketed in Canada since 1987 as a laxative for the relief of occasional constipation. The product is also used as part of a bowel-cleansing regimen in preparing patients for surgery or for...

Correction.
January 1, 2002... In WHO Drug In formation, volume 15, No. 2, 2001, an error was made on page 77 in the summarized information: Terbinafine and hepatic failure. The brand name product in question is Lamisil[R] (and not Lamictal[R] as stated).

Pilot Procurement Project for quality and sourcing (pre-qualification) of HIV/AIDS drugs. (Quality Assurance Issues).
January 1, 2002... In October 2000, WHO, UNICEF, UNFPA, and UNAIDS, supported by the World Bank, invited manufacturers of drugs for treatment of HIV infection (antiretrovirals) and HIV-related illnesses (anti-infectives, anticancer drugs, and pain killers) to...

WHO Guidelines on stability testing. (Recent Publications and Sources of Information).
January 1, 2002... Work on stability of pharmaceutical products was initiated by WHO in 1988 and the WHO Guidelines on stability testing were adopted in 1998 by the WHO Expert Committee on Specifications for Pharmaceutical Preparations following extensive...

WHO Model Formulary now available. (Recent Publications and Sources of Information).
January 1, 2002... In 1995, the WHO Expert Committee on the Use of Essential Drugs recommended development of a WHO Model Formulary to complement the WHO Model List of Essential Drugs. It was considered that this would be a useful resource for countries wishing...

Direct to consumer advertising. (Recent Publications and Sources of Information).
January 1, 2002... The Council of the Royal Pharmaceutical Society of Great Britain has today decided its position on the issue of direct-to-consumer advertising (DCTA) of prescription medicines. The Council recognises that further developments in DTCA are...

The information gap: new resource for developing countries. (Recent Publications and Sources of Information).
January 1, 2002... www.scidev.net was launched last week to bridge the divide between knowledge-rich developed countries and the knowledge-poor developing world. Sponsored by the journals Nature and Science, the site was created on the premise that "those who...

International Nonproprietary Names for Pharmaceutical Substances (INN).
January 1, 2002... 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 list on the following pages are under...

International Nonproprietary Names for Pharmaceutical Substances (INN).
January 1, 2002... RECOMMENDED International Nonproprietary Names (Rec. INN): List 47 Notice is hereby given that, in accordance with paragraph 7 of the Procedure for the Selection of Recommended International Nonproprietary Names for Pharmaceutical...