WHO Drug Information articles from June 2003

WHO Drug Information archives from June 2003

Prescribing information in 26 countries.(Rational Use of Drugs)
June 22, 2003... Pharmaceutical products approved for marketing are generally accompanied by information targeted to health care prescribers and patients. The International Comparative Study on Drug Information (ICSODI) Collaborative Group has recently...

Virologic non-response in HIV drugs.(Safety and Efficacy Issues)
June 22, 2003... A high rate of early virologic non-response has been observed in a clinical study of therapy-naive adults receiving once-daily three-drug combination therapy with lamivudine (Epivir[R]), abacavir (Ziagen[R]) and tenofovir (Viread[TM]) (1). ...

Hyponatraemia with SSRIs.(Safety and Efficacy Issues)
June 22, 2003... The Australian Adverse Reactions Advisory Committee (ADRAC) has received a total of 311 reports of hyponatraemia involving serotonin selective reuptake inhibitors (SSRIs) and venlafaxine. In 67 of these reports, it was indicated that the...

Salmeterol labelling changes.(Safety and Efficacy Issues)
June 22, 2003... The Food and Drug Administration (FDA) has announced new safety information and warnings to be added to the labelling for drug products containing the long-acting bronchodilator, salmeterol, used to treat asthma and chronic obstructive...

Pregnancy during depot medroxyprogesterone use.(Safety and Efficacy Issues)
June 22, 2003... The Australian Adverse Reactions Advisory Committee (ADRAC) has received 27 reports of women becoming pregnant despite using depot medroxyprogesterone products (Depo-Provera[R], Depo-Ralovera[R]) for contraception. In ten of the cases, the...

Etonogestrel and vaginal bleeding.(Safety and Efficacy Issues)
June 22, 2003... Since August 2001, the Australian Adverse Reactions Advisory Committee (ADRAC) has received 130 adverse reaction reports for Implanon[R] (subdermal etonogestrel contraceptive implant), including 37 reports of vaginal bleeding, most of which...

Hepatic reactions with minocycline.(Safety and Efficacy Issues)
June 22, 2003... Minocycline is an effective long-term treatment for severe acne, but is associated with serious adverse reactions, including rare cases of hepatic dysfunction. In one study, the incidence of hepatic reactions in new users was one case/10 000...

Hepatobiliary reactions with the newer antidepressants.(Safety and Efficacy Issues)
June 22, 2003... Health Canada continues to monitor suspected hepatobiliary adverse reactions (ARs) associated with the newer antidepressants that exert an effect on serotonin neurotransmission. These include citalopram (Celexa[R]), fluoxetine (Prozac[R]),...

Convulsions with newer-generation antihistamines.(Safety and Efficacy Issues)
June 22, 2003... Antagonists of histamine [H.sub.1] receptors are commonly classified as first-generation or new-generation antihistamines based on their frequent sedating effect at therapeutic doses. The "newer-generation" antihistamines, also known as second-...

Rifampicin and pyrazinamide not to be used for latent tuberculosis infection.(Safety and Efficacy Issues)
June 22, 2003... The Centers for Disease Control (CDC) has reported severe liver injury in patients treated for latent tuberculosis infection (LTBI) with a daily and twice-weekly 2-month regimen of rifampicin (US: rifampin) with pyrazinamide (RZ). On the basis...

The role of statins in primary prevention.(Individual Drugs)
June 22, 2003... Two important questions regarding statin therapy are: * What is the overall health impact when statins are prescribed for primary prevention? * Should the dose of statin be titrated to achieve target lipid levels? Throe new...

A strategy to reduce cardiovascular disease by more than 80%?(Individual Drugs)
June 22, 2003... Heart attacks, stroke, and other preventable cardiovascular diseases kill or seriously affect many populations. Western diet and lifestyle increase levels of risk factors and their combined effects have made these diseases common....

Pre-qualification of HIV drugs.(Aspects of Quality Assurance)
June 22, 2003... The Pilot Procurement, Quality and Sourcing Project for HIV Drugs was created in October 2000 by WHO, UNICEF, UNFPA, and UNAIDS, with support from the World Bank. Its objective is to pre-qualify manufacturers of medicines for HIV...

Access to generic antiretrovirals.(Aspects of Quality Assurance)
June 22, 2003... In 2002, the number of people living with HIV/ AIDS reached 42 million, with 5 million newly infected cases annually (1). Addressing this crisis demands not only rapid expansion of HIV/AIDS prevention, but also scaling up of treatment and care,...

List of pre-qualified products: 20 August 2003.(Aspects of Quality Assurance)
June 22, 2003... List of pre-qualified products: 20 August 2003 INN strength dosage supplier form abacavir 300 mg tablet GlaxoSmithKline abacavir ...

The International Pharmacopoeia--monographs for antiretrovirals.(Consultation Document)
June 22, 2003... Within the framework of the Pilot Procurement Project for Quality and Sourcing of HIV Drugs, the International Pharmacopoeia is collaborating with manufacturers, independent analytical drug quality control laboratories, national and regional...

Didanosinum: didanosine.(Consultation Document)
June 22, 2003... Description: White to almost-white powder. Solubility: Sparingly soluble in water; slightly soluble in methanol R and ethanol (-750 g/l) TS. Category: Antiretroviral (nucleoside reverse transcriptase inhibitor). Storage:...

Nimesulide temporarily suspended.(Regulatory and Safety Action)
June 22, 2003... Finland -- The National Agency for medicines, together with the manufacturer, has decided to suspend the distribution, sale and supply of nimesulide (Nimed[R]) pending a review. Nimesulide is an anti-inflammatory analgesic approved for...

Topiramate: revised prescribing information.(Regulatory and Safety Action)
June 22, 2003... United States of America/Canada -- The manufacturer of topiramate (Topamax[R]) has updated the product information based on clinical trial and post-marketing experience in more than 2 million patients worldwide. Rare reports, primarily...

Omalizumab for allergy-related asthma.(Regulatory and Safety Action)
June 22, 2003... United States of America -- The Food and Drug Administration (FDA) has approved the first biotechnology product to treat patients with allergy-related asthma. Omalizumab (Xolair[R]), is a monoclonal antibody shown to be safe and effective for...

Co-packaged treatments for cerebrovascular events.(Regulatory and Safety Action)
June 22, 2003... United States of America -- The Food and Drug Administration (FDA) has approved Pravigard PAC[R] (co-packaged pravastatin sodium and buffered aspirin tablets) for use when treatment is appropriate. Pravachol and buffered aspirin are indicated...

OTC omeprazole approved for heartburn.(Regulatory and Safety Action)
June 22, 2003... United States of America -- The Food and Drug Administration (FDA) has approved omeprazole (Prilosec OTC[R]), the first over-the-counter treatment for frequent heartburn. Unlike the two classes of currently marketed over-the-counter...

Recombinant antihaemophilic factor licensed.(Regulatory and Safety Action)
June 22, 2003... United States of America -- The Food and Drug Administration (FDA) has licensed a new recombinant DNA-derived clotting factor to treat people with haemophilia A. This new anti-haemophilic human factor VIII product is the first produced without...

New diabetes device approved.(Regulatory and Safety Action)
June 22, 2003... United States of America -- The Food and Drug Administration (FDA) has cleared the first device for diabetics which integrates a glucose meter and insulin pump with a dose calculator. The new device could be the first step in the development of...

Recombinant somatropin approved for short stature.(Regulatory and Safety Action)
June 22, 2003... United States of America -- The Food and Drug Administration (FDA) has approved a new indication for somatropin, rDNA origin, for injection (Humatrope[R]), a brand of growth hormone, for the long-term treatment of children with idiopathic short...

Diagnostic test for West Nile virus.(Regulatory and Safety Action)
June 22, 2003... United States of America -- The Food and Drug Administration (FDA) has approved the first test for use in the clinical laboratory diagnosis of West Nile virus infection. West Nile Virus IgM Capture ELISA[R] is intended for use in patients with...

Etanercept for ankylosing spondylitis.(Regulatory and Safety Action)
June 22, 2003... United States of America -- The Food and Drug Administration (FDA) has approved an application for etanercept (Enbrel[R]), a genetically-engineered protein, for a new indication for treatment of patients with active ankylosing spondylitis (AS),...

Porfimer sodium approved for Barrett oesophagus.(Regulatory and Safety Action)
June 22, 2003... United States of America -- The Food and Drug Administration (FDA) has approved porfimer sodium Injection (Photofrin[R]) for the ablation of precancerous lesions (high-grade dysplasia) in Barrett oesophagus patients who do not undergo surgery...

New drug approved for lowering cholesterol.(Regulatory and Safety Action)
June 22, 2003... United States of America -- The Food and Drug Administration (FDA) has approved a new HMG-CoA reductase inhibitor, rosuvastatin (Crestor[R]), to lower cholesterol. Rosuvastatin was approved based on multiple trials of at least 6 weeks'...

Regulation of fixed-dose combination products.(Regulatory Challenges)
June 22, 2003... Internationally, there is an increasing trend to license fixed-dose combination products for the market. In less well-resourced countries, fixed-dose combination products (FDCs) hold a particular attraction in the treatment of communicable...

ATC/DDD classification (final).
June 22, 2003... ATC/DDD Classification (final) 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...

ATC/DDD classification (temporary).
June 22, 2003... ATC/DDD Classification (temporary) 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...

International Nonproprietary Names for Pharmaceutical Substances (INN).
June 22, 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...