WHO Drug Information articles from March 2004

WHO Drug Information archives from March 2004

Stability testing for hot and humid climates.(Aspects of Quality Assurance)
March 22, 2004... In 1996, the WHO Expert Committee on Specifications for Pharmaceutical Preparations adopted the WHO Guidelines on Stability Testing (1). In 2000, the International Conference on Harmonization (ICH) Expert Working Group proposed a modification...

Efficacy of artesunate for emergency malaria treatment.(Safety and Efficacy Issues)
March 22, 2004... Plasmodium falciparum malaria causes hundreds of thousands of deaths annually, especially in children in sub-Saharan Africa. Many of those living in malaria-endemic areas do not have ready access to health facilities and for patients too ill...

Natural health products and drug interactions.(Safety and Efficacy Issues)
March 22, 2004... Canadian Natural Health Products Regulations came into force in January 2004, and will be implemented in stages over 6 years. As with other product lines, reporting of adverse reactions (AR) to natural health products is now mandatory for...

Valdecoxib: severe cutaneous reactions.(Safety and Efficacy Issues)
March 22, 2004... Valdecoxib (Bextra[TM]), a selective inhibitor of cyclo-oxygenase 2 (COX-2), is indicated for the treatment of acute and chronic signs and symptoms of adult rheumatoid arthritis and osteoarthritis as well as for the relief of pain associated...

An international role for nomenclature through INNs.(International Nonproprietary Names (INN))
March 22, 2004... The global pharmaceuticals market is characterized by the huge choice of medicinal preparations available to satisfy the demands of many diseases and conditions. As the range of preparations has expanded internationally, it has become...

SSRIs: behavioural and emotional changes and risk of self-harm.(Regulatory and Safety Action)
March 22, 2004... Canada -- Health Canada is advising that selective serotonin re-uptake inhibitors (SSRIs) and other new antidepressants now carry stronger warnings. These warnings indicate that patients of all ages taking these drugs may experience...

Proposed rule on combination products.(Regulatory and Safety Action)
March 22, 2004... United States of America -- The Food and Drug Administration (FDA) has announced a proposed rule to assign a lead centre with responsibility for premarket review and regulation of a combination product. Combination products are...

European Medicines Agency: new name and advisory role.(Regulatory and Safety Action)
March 22, 2004... European Union -- The European Agency for the Evaluation of Medicinal products (EMEA) has recently undergone a review based on experience gained during the six years since its establishment. EMEA will now be renamed The European Medicines...

Atypical antipsychotics warning.(Regulatory and Safety Action)
March 22, 2004... United States of America -- In 2003, the Food and Drug Administration (FDA) asked all manufacturers of atypical antipsychotic medications, to add a warning on the increased risk of hyperglycaemia and diabetes in patients taking these...

Tegaserod maleate: updated precautions.(Regulatory and Safety Action)
March 22, 2004... United States of America -- The manufacturer of tegaserod maleate tablets (Zelnorm[R]) has advised prescribers of an important drug warning and prescribing information. Tegaserod maleate is a serotonin 5-HT4 receptor partial agonist indicated...

Rotavirus vaccine ready for licensing.(Regulatory and Safety Action)
March 22, 2004... In 1999, the oral rotavirus vaccine, Rotasheld[R] was withdrawn from the market by the manufacturer following reports of intussusception (1, 2). The US National Institute of Allergy and Infectious Diseases (NIAID), part of the National...

Tenofovir approved for HIV.(Regulatory and Safety Action)
March 22, 2004... Canada -- Health Canada has issued a marketing authorization for tenofovir disoproxil fumarate (Viread[R]), a new nucleotide reverse transcriptase inhibitor which is conditional on the conduct of confirmatory studies to verify the clinical...

Rosuvastatin: revised package insert.(Regulatory and Safety Action)
March 22, 2004... United States of America -- The manufacturer of rosuvastatin (Crestor[R])) has released a revised package insert for use in 22 member countries of the European Union (EU). The changes to the European labeling are in response to post-marketing...

Sulphur hexafluoride: contraindicated in heart disease.(Regulatory and Safety Action)
March 22, 2004... European Union -- Severe allergy and heart problems have been reported as rare side effects occurring within minutes of of sulphur hexafluoride administration (Sonovue[R]), a diagnostic contrast medium for use with ultrasound imaging where...

Oxandrolone and warfarin.(Regulatory and Safety Action)
March 22, 2004... United States of America -- The manufacturer of oxandrolone (Oxandrin[R]) has provided new safety information when used concurrently with the oral anticoagulant warfarin for systemic anticoagulation. Oxandrolone, a synthetic derivative of...

Oseltamivir: new preclinical findings.(Regulatory and Safety Action)
March 22, 2004... Singapore -- Oseltamivir (Tamiflu[R], Roche) was recently licensed for the treatment of uncomplicated illness due to influenza infections in children one year of age and older who have been symptomatic for no more than 2 days. It has been...

Muromonab: nervous system complications.(Regulatory and Safety Action)
March 22, 2004... Canada -- The manufacturer of muromonab-CD3 (Orthoclone OKT*3[R]) has informed Canadian hospitals of important new safety information. Muromonab is used to treat acute rejection from liver, kidney, and heart transplants that do not respond to...

Domperidone and unapproved use.(Regulatory and Safety Action)
March 22, 2004... United States of America -- In response to reports that women may be using an unapproved drug, domperidone, to increase milk production (lactation), the Food and Drug Administration (FDA) is warning breastfeeding women not to use this product...

Combating counterfeit medicines *.(Safety of Medicines)
March 22, 2004... Substandard medicines are products whose composition and ingredients do not meet the correct scientific specifications and which may consequently be ineffective and often dangerous to the patient. Substandard products may occur as a result of...

New oral rehydration solution adopted by WHO and UNICEF.(Current Topics)
March 22, 2004... For more than 25 years, WHO and UNICEF have recommended a single formulation of glucose based oral rehydration solution to prevent or treat diarrhoeal dehydration, no matter from what cause or affected age group. This solution has played a...

A single oral rehydration solution for global use?(Current Topics)
March 22, 2004... Diarrhoeal diseases remain important causes of death and morbidity in developing countries, with an estimated 1.5 billion episodes and 1.5 million to 2.5 million deaths each year among children younger than 5 years (1-4). A critical factor in...

Principles for fixed-dose combination drug products.(Current Topics)
March 22, 2004... A statement has been issued by the Southern African Development Community (SADC), United Nations Joint Programme on HIV/AIDS (UN-AIDS), US Department of Health and Human Services (HHS) and the World Health Organization (WHO) on the scientific...

Mozambique issues compulsory license for HIV antiretrovirals.(Current Topics)
March 22, 2004... The HIV/AIDS pandemic constitutes a serious handicap in Mozambique's struggle against hunger, illness, underdevelopment and misery. High rates of morbidity and mortality have put Mozambique among the ten countries in Africa worst hit by HIV....

Improved use of medicines.(Current Topics)
March 22, 2004... Over 450 leading multi-disciplinary researchers, national and international policy makers, patient advocates and clinicians representing nearly 80 countries recently gathered in Thailand for the Second International Conference on Improving...

Rapid TB diagnostic test by 2005.(Current Topics)
March 22, 2004... The Foundation for Innovative New Diagnostics (FIND) has announced development of a rapid economical TB test aimed to provide tuberculosis results within 48 hours, rather than weeks. The new TB test is expected to be available in 2005. ...

Research bioethics training.(Current Topics)
March 22, 2004... The Johns Hopkins University Bloomberg School of Public Health and Bioethics Institute, in collaboration with the US National Institutes of Health (NIH), Department of Clinical Bioethics, are pleased to announce the availability of a one year...

The International Pharmacopoeia: monographs for antiretrovirals (second draft).(Consultation Document)
March 22, 2004... Within the framework of the Pilot Procurement Project for Quality and Sourcing of HIV Drugs (http://www.who.int/medicines), the International Pharmacopoeia is collaborating with manufacturers, independent analytical drug quality control...

ATC/DDD classification (Final).
March 22, 2004... The following final anatomical therapeutic chemical (ATC) classifications and defined daily doses (DDDs) were agreed at a meeting of the WHO International Working Group for Drug Statistics Methodology which took place in October 2003....

ATC/DDD classification (temporary).
March 22, 2004... The following temporary anatomical therapeutic chemical (ATC) classifications, defined daily doses (DDDs) and alterations were agreed at a meeting of the WHO International Working Group for Drug Statistics Methodology which took place on...

Recent publications and sources of information.
March 22, 2004... Specifications for pharmaceutical preparations The latest report from the WHO Expert Committee on Specifications for Pharmaceutical Preparations has now been published. The report contains recommendations on the quality assurance of...