WHO Drug Information articles from January 2003

WHO Drug Information archives from January 2003

Women's Health Initiative Study. (Reports on Individual Drugs).
January 1, 2003... The Women's Health Initiative Study (WHI) was sponsored by the US National Institutes of Health to evaluate the effects of hormone replacement therapy (HRT). Results of the study have now been reviewed in many countries, and some highlights are...

Menopausal combined hormone therapy update: Canada. (Reports on Individual Drugs).
January 1, 2003... The Women's Health Initiative (WHI) trial is a striking example of how scientific evidence can improve prescribing practice (1). Evidence on hormone replacement therapy in 1999 showed that long-term estrogen/progestin therapy to prevent...

Women's Health Initiative data review: USA. (Reports on Individual Drugs).
January 1, 2003... The Food and Drug Administration (FDA) has advised of new safety changes to labelling of all estrogen and estrogen/progestin products for use by postmenopausal women. These changes reflect an analysis of data from the Women's Health Initiative...

Future of hormone replacement therapy: Australia. (Reports on Individual Drugs).
January 1, 2003... The premature cessation of one arm of the ongoing US Women's Health Initiative study (WHI) undoubtedly caused more media than scientific alarm (1). The study is very important, as it was one of only two studies of long-term hormone replacement...

Hormone replacement therapy recommendations: New Zealand. (Reports on Individual Drugs).
January 1, 2003... At its meeting of 11 September 2002, the New Zealand Medicines Adverse Reactions Committee (MARC) reviewed studies examining the safety of hormone replacement therapy (HRT). On completion of its review, the MARC concluded that HRT provides a...

Quality assurance and safety of biologicals. (Vaccines and Biomedicines).
January 1, 2003... In order to assure the quality and safety of biological medicines and in vitro diagnostic procedures, the WHO Expert Committee on Biological Standardization provides guidance and technical specifications through the establishment of...

Direct-to-consumer drug advertising: survey results. (Current Topics).
January 1, 2003... The US Food and Drug Administration (FDA) has released results of its survey on direct-to-consumer (DTC) advertising for prescription drugs among 500 physicians. The results show that DTC advertising, when carried out correctly, can serve...

Race and ethnicity data in clinical trials. (Current Topics).
January 1, 2003... The United States Food and Drug Administration (FDA) has published a draft Guidance for Industry to recommend categories for collecting effectiveness and safety data during clinical trials for ethnic and racial demographic groups. FDA...

HIV vaccine update. (Current Topics).
January 1, 2003... Preliminary results of a large-scale trial of a candidate AIDS vaccine (AIDSVAX[R]) have been announced by the biotechnology company VaxGen. The trial was a three year, multinational randomized, double-blind placebo controlled Phase III trial...

Drug bar code regulation proposed. (Current Topics).
January 1, 2003... In an effort to improve patient safety in the hospital setting by reducing medication errors, the Food and Drug Administration (FDA) has published a proposed rule entitled Bar Code Label Requirements for Human Drug Products and Blood. Medical...

Terminology in pharmacogenetics. (Current Topics).
January 1, 2003... As a result of the development within the areas of genetics and genomics, changes are likely to occur in the way drug development is currently being conducted and the way medicines will be used. The use of terms that are harmonized and widely...

New tool to boost access to quality medicines and detect counterfeits. (Current Topics).
January 1, 2003... To improve the quality and efficacy of medicines, facilitate control of counterfeit and substandard drugs and address problems of drug resistance, the World Health organization has released a new edition of The International Pharmacopoeia (see...

WHO Drug Dictionary: new structure - new focus. (Safety Issues).
January 1, 2003... For those working in pharmacology and drug safety, the WHO Drug Dictionary (WHO-DD) has been an international consolidated reference source of drug names and related information for over 20 years. During that time, the Drug Dictionary has...

Tramadol - safety experience. (Safety Issues).
January 1, 2003... Tramadol (Tramal[R]) is a centrally acting analgesic which has been available in Australia for four years. Although chemically unrelated to the opiates, it stimulates opioid receptors and inhibits noradrenaline and serotonin uptake. The...

Minocycline and intracranial hypertension. (Safety Issues).
January 1, 2003... Benign intracranial hypertension, also known as pseudotumour cerebri, involves a persistent rise in cerebrospinal fluid pressure. It is characterized by headache, nausea, vomiting and papilloedema with occasional sixth-nerve palsy. It is...

Neuropsychiatric events: celecoxib and rofecoxib. (Safety Issues).
January 1, 2003... Acute neuropsychiatric reactions are known to occur with the nonselective NSAIDs, and are mentioned in the product information for these medicines, It appears that they may also be a class effect for the selective COX-2 inhibitors, including...

Linezolid: peripheral neuropathy. (Safety Issues).
January 1, 2003... Linezolid (Zyvox[R]) is a new antibiotic indicated for the treatment of suspected or proven infections due to organisms resistant to multiple classes of antibiotics. The Australian Adverse Drug Reactions Committee (ADRAC) has received 4 reports...

Zonisamide and visual hallucinations. (Safety Issues).
January 1, 2003... Zonisamide is a broad-spectrum anti-epileptic drug used to treat various types of seizures. Although visual hallucinations have not been reported as an adverse effect of this agent, the following article extracted from Pharmacotherapy (1)...

Salmeterol study halted. (Safety Issues).
January 1, 2003... United States of America -- The Food and Drug Administration (FDA) has announced an interim analysis of a large safety study of the approved asthma drug salmeterol xinafoate (Serevent[R] Inhalation Aerosol), a [beta.sub.2]-receptor agonist. It...

Labelling and manufacturing of dietary supplements. (Safety Issues).
January 1, 2003... The Food and Drug Administration has proposed a new regulation to require current good manufacturing practices (cGMPs) in manufacturing, packing and holding of dietary supplements. The proposed rule would establish standards to ensure that...

Dietary supplements containing ephedra. (Safety Issues).
January 1, 2003... The US Department of Health and Human Services (HHS) has announced a series of measures concerning dietary supplements containing ephedra. On the basis of new evidence in the medical literature and adverse event reports, there are reasons...

Topical use of Lindane. (Safety Issues).
January 1, 2003... The US Food and Drug Administration (FDA) has issued a Public Health Advisory concerning the use of topical formulations of Lindane[R] lotion and lindane[R] shampoo (gamma-hexachlorocyclohexane) for the treatment of scabies and lice. In...

Use of praziquantel in pregnant and lactating women. (Essential Medicines).
January 1, 2003... Praziquantel, the drug of choice for the treatment of all types of schistosomiasis, was first released under a patent by Bayer (Leverkusen, Germany) in 1979 and at that time underwent the mandatory toxicology testing. However, despite few data...

Benzimidazoles: use in children. (Essential Medicines).
January 1, 2003... The prevalence and intensity of infection with soil-transmitted helminths tends to be low in children aged less than 24 months. Nevertheless, there is growing evidence that infection detrimentally affects their growth and development. This age...

Praziquantel 'dose pole' for large scale deworming. (Essential Medicines).
January 1, 2003... The usefulness of dose poles, used to decide the appropriate drug dose on the basis of people's height instead of their weight, has been demonstrated in the Onchocerciasis Control Programme in West Africa, where it has been used extensively for...

Poor access to praziquantel at the peripheral health care level. (Essential Medicines).
January 1, 2003... The price of anthelminthic drugs has plummeted over the past few years and this is particularly true for praziquantel. Praziquantel can now be delivered to patients in peripheral health care structures for less than US$ 0.10 per 600 mg tablet,...

New class of HIV treatment approved. (Regulatory and Safety Action).
January 1, 2003... United States of America -- The Food and Drug Administration (FDA) has announced the accelerated approval of enfuvirtide (Fuzeon[R]) for use in combination with other anti-HIV medications to treat advanced HIV-1 infection in adults and children...

Influenza vaccine composition: Northern hemisphere. (Regulatory and Safety Action).
January 1, 2003... World Health organization -- It is recommended that vaccines to be used in the 2003/2004 Winter season contain the following strains: * an A/New Caledonia/20/99 (H1N1)-like strain * an A/Moscow/10/99/(H3N2)-like strain (A widely-used...

New labelling for conjugated estrogens. (Regulatory and Safety Action).
January 1, 2003... United States of America -- The manufacturer of conjugated estrogens/medroxyprogesterone acetate (Prempro[TM]) (Premphase[R]), and conjugated estrogens tablets (Premarin[R]) has informed health care professionals of new labelling changes. These...

Fibrinolytics in diabetic patients. (Regulatory and Safety Action).
January 1, 2003... European Union -- The following Position Statement has been published by the Committee for Proprietary Medicinal products (CPMP) on use of fibrinolytics in diabetic patients. Intravenous (iv) fibrinolytic agents are indicated for the...

Precautions for blood and urine--derived products. (Regulatory and Safety Action).
January 1, 2003... United Kingdom -- The Committee on Safety of Medicines (OSM) has advised that gonadotropin [Metrodin High Purity (HP)[R]] should no longer be used. Gonadotropin is used predominantly for strong stimulation of the ovary in women undergoing in...

Gefitinib: safety measures. (Regulatory and Safety Action).
January 1, 2003... Japan -- The Pharmaceutical Affairs Bureau has announced safety measures to be taken for use of gefitinib (Iressa[R]) following the announcement of deaths associated with use (1). Gefitinib is the first in a new class of epidermal growth...

Nefazodone withdrawal. (Regulatory and Safety Action).
January 1, 2003... Spain -- Nefazodone, an antidepressant, has been marketed in Spain since 1997. Recently, as a consequence of rare but serious hepatotoxic adverse reactions reported in Spain and elsewhere, the Committee on Safety of Human Use Medicines has...

Amifostine: serious reactions. (Regulatory and Safety Action).
January 1, 2003... Spain -- The Spanish Medicines Agency, in coordination with other European Union regulatory authorities, has modified the labelling and package insert for amifostine (Ethyl[R]) (1). Amifostine is used as a chemotherapeutic agent to (i) protect...

Sirolimus: not recommended in lung transplant. (Regulatory and Safety Action).
January 1, 2003... United States of America -- The manufacturer of sirolimus (Rapamune[R]), which is indicated for the prophylaxis of organ rejection in patients receiving renal transplants, has received post-marketed reports of bronchial anastomotic dehiscence,...

Interferon beta-1 a: strengthened labelling. (Regulatory and Safety Action).
January 1, 2003... United States of America -- The manufacturer of interferon beta-1a (Avonex[R]) has informed healthcare professionals of several changes to the prescribing information. The clinical studies section of the labelling for interferon beta-1a...

Palivizumab: prescribing information changes. (Regulatory and Safety Action).
January 1, 2003... United States of America -- At the time Palivizumab (Synagis[R]) was licensed, there wen no observed cases of anaphylaxis. However, because of the protein nature of the product, such reactions could be anticipated and was presented as a...

Epigallocatechin gallate marketing suspension. (Regulatory and Safety Action).
January 1, 2003... France -- The French Agency for Safety of Medicines has suspended the marketing authorization for Epigallocatechin gallate (Exolise[R]), a particularly strong phytotherapeutic extract of green tea (Camellia sinensis). It is indicated as an...

Pergolide mesilate: strengthened warning. (Regulatory and Safety Action).
January 1, 2003... United States of America -- During post-marketing surveillance of pergolide mesilate (Permax[R]), a small number of individuals have been identified as developing cardiac valvulopathy involving one or more valves. Pergolide is indicated as...

WHO's new bookshop. (Recent Publications and Sources of Information).
January 1, 2003... The World Health Organization is now providing an electronic bookshop facility on http://www.who.int/dsa. An on- line electronic catalogue gives information on WHO publications and other information support systems such as CD-ROM and video. It...

WHO monographs on medicinal plants. (Recent Publications and Sources of Information).
January 1, 2003... Volume Two of Monographs on Selected Medicinal Plants has now been published by WHO and includes an additional collection of 30 monographs to complement those of Volume 1. The monographs provide scientific information on the safety, efficacy...

International Pharmacopoeia: Volume 5. (Recent Publications and Sources of Information).
January 1, 2003... The latest edition of The International Pharmacopoeia: Tests and General Requirements for Dosage Forms. Quality Specifications for Pharmaceutical Substances and Tablets describes methods and procedures for the quality control of pharmaceutical...

HIV treatment newsletter. (Recent Publications and Sources of Information).
January 1, 2003... HIV and AIDS Treatment in Practice is a free-of-charge e-mail newsletter which has been launched for doctors, nurses and health care workers. The newsletter is published by a UK information charity. A voluntary advisory panel consisting of...

Fixed-dose combinations for tuberculosis drugs. (Recent Publications and Sources of Information).
January 1, 2003... Ensuring that people with tuberculosis complete a full course of treatment is one of the major challenges of TB control. The risk is that uninformed patients or doctors may change the regimen, avoiding one or more of the drugs they believe are...

Malaria: interactive self-assessment. (Recent Publications and Sources of Information).
January 1, 2003... The malaria educational site at the Royal Perth Hospital, Australia, is available in French, English and Spanish. The site contains sections on diagnosis, prophylaxis, treatment and history of malaria as well as an interactive self assessment...

International Nonproprietary Names for Pharmaceutical Substances (INN).
January 1, 2003... 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...