WHO Drug Information articles from March 2000

WHO Drug Information archives from March 2000

Generic drugs: the hidden issues of quality and cost.
March 22, 2000... Jean- Yves Videau, Centrale humanitaire medicopharmaceutique(CHMP), France, (http://www.chmp.org) in collaboration with Bonnie Fundafunda, Echo International Health Services, United Kingdom (http://www.echohealth.org.uk) As we move into...

Pharmaceutical policies and regulatory control.
March 22, 2000... In an ideal world, all countries would have abundant medicines which are safe, effective and of good quality and regulated by a competent national drug regulatory authority respected for its expertise, professionalism, efficiency, independence,...

Reports on Individual Drugs.
March 22, 2000... New use for artemether in schistosomiasis Evidence suggests that artemether could have a major impact on the control of schistosomiasis. Since the early 1990s, evidence has been accumulating to support the prophylactic use of the...

Clopidogrel and thrombotic thrombocytopenic purpura.
March 22, 2000... The antiplatelet drug clopidogrel is a new thienopyridine derivative with a mechanism of action and chemical structure similar to ticlopidine. The estimated incidence of ticlopidine-associated thrombotic thrombocytopenic purpura is 1 per 1600...

Statins: benefit in cardiovascular disease extended to bone fracture.
March 22, 2000... Two population-based, case-control studies were carried out to determine the risk of fractures and risk of hip fractures in elderly patients following exposure to lipid-lowering drugs. The results showed that women and men taking any kind of...

Cholera: can rehydration therapy be improved?
March 22, 2000... Diarrhoeal diseases rank high among the leading causes of mortality in African, Eastern Mediterranean and South-East Asian countries causing annually more than 2.5 million deaths [1]. It is estimated that at least 4 billion episodes of...

Antibiotics, E. coil and haemolytic-uraemic syndrome.
March 22, 2000... The pathogenesis of the haemolytic-uraemic syndrome that is associated with infection with entero-haemorrhagic Escherichia coil is not well understood. The organisms apparently colonize the intestine after being ingested in contaminated food or...

Orlistat associated with hypertension.
March 22, 2000... The latest drug for weight reduction, orlistat, was approved for use in Sweden in July 1998, and by September 1999 13 million defined daily doses (360 mg per defined daily dose) had been sold. Steatorrhoea and other gastrointestinal disorders...

The WHO-UNAIDS Care and Support Strategy.
March 22, 2000... Building on the work of UNAIDS, and in collaboration with co-sponsors and partners worldwide, a new initiative is under way to enhance the health capacity of countries and increase access to HIV care and treatment. The principle objective of...

Interagency Task Team on Access to HIV-Related Drugs.
March 22, 2000... Problems in assuring the availability, affordability, quality, and rational use of drugs are universal, but access to HIV-related drugs in developing countries and underprivileged communities presents particular challenges. In many cases, HIV...

Pneumococcal vaccine: recommendations for use.
March 22, 2000... United States of America -- The Federal Advisory Committee on Immunization Practices has recommended administration of pneumococcal vaccine during the 2000-2001 flu season. The vaccine has a demonstrated effectiveness of almost 70% in...

Valaciclovir: neuropsychiatric reactions.
March 22, 2000... Australia -- Valaciclovir is an antiviral prodrug of aciclovir used in the treatment of herpes infections. The Adverse Drug Reactions Advisory Committee has received 69 reports of minor reactions including headache, nausea, rash, dizziness....

Zanamivir: revisions to labelling.
March 22, 2000... The manufacturer of zanamivir (Relenza [R] Glaxo Wellcome Inc.), has circulated an important warning on revisions to the safety labelling of the product, which was approved in 1999 for the treatment of uncomplicated acute illness due to...

Celecoxib: adverse reaction reports.
March 22, 2000... Australia -- Since October 1999 the Adverse Drug Reaction Advisory Committee has received 919 reports of suspected adverse reactions to celecoxib the first in the class of COX-2 inhibitors to be marketed. In 869 reports, celecoxib was the only...

Olanzapine: serious reactions.
March 22, 2000... Canada -- Olanzapine, an atypical antipsychotic, was first marketed in July 1996 for treatment of schizophrenia and related psychotic disorders. A total of 153 reports of suspected adverse drug reactions associated with olanzapine have so far...

Infliximab approved for rheumatoid arthritis.
March 22, 2000... European Union -- The European Commission has granted marketing authorization for infliximab, (Remecade [R]) for use in combination with methotrexate in the reduction of signs and symptoms of rheumatoid arthritis in patients with active...

Tenecteplase: the first "clot buster".
March 22, 2000... United States of America -- The Food and Drug Administration has approved tenecteplase for the reduction of mortality associated with acute myocardial infarction. The product is a single-bolus thrombolytic agent having the potential to simplify...

Bupropion: a new approach to smoking cessation.
March 22, 2000... United Kingdom -- Bupropion, (Zyban [R]) the first non-nicotine prescription medicine for use as an aid to smoking cessation has been launched. It acts as a dopamine and noradrenaline reuptake inhibitor to break the cycle of addiction: dopamine...

Doxorubicin for ovarian cancer.
March 22, 2000... European Union/United States of America -- The Committee for Proprietary Medicinal Products (CPMP) has recommended approval of pegylated liposomal doxorubicin hydrochloride (Caelyx [R]) for the treatment of advanced ovarian cancer in women who...

Linezolid: the first oxazolide antimicrobial approved.
March 22, 2000... United States of America -- The Food and Drug Administration has approved linezolid, (Zyvox[R]), the first antibacterial drug of the new oxazolidines class to treat infections associated with vancomycin-resistant Enterococcus faecium, including...

Guidance for adverse reactions labelling.
March 22, 2000... United States of America -- The Food and Drug Administration has issued a draft guidance for the development of the adverse reactions section of labelling for human prescription drugs and biologicals. The document, which was published in June,...

Legislation adopted in Europe on orphan drugs.
March 22, 2000... European Union -- In a bid to encourage the pharmaceutical industry to invest in developing treatments for diseases which are rare or not economically viable, legislation has been adopted to stimulate new treatment options for patients....

More drug safety measures planned in Japan.
March 22, 2000... Japan -- The Ministry of Health and Welfare will propose new drug safety measures, including standardization of safety measures. The Ministry will continue to study ways to improve drugs and medical devices that are liable to be misused or...

"Street drug alternatives" are not dietary supplements.
March 22, 2000... United States of America -- The Food and Drug Administration has made a review of 140 reports of adverse drug reactions linked to the use of dietary supplements containing ephedrine alkaloids. The FDA has called for additional information...

Tamsulosin: syncope now reported.
March 22, 2000... Japan -- Tamsulosin was marketed in 1993 for dysuria due to prostatic hypertrophy. Based on reports received during the first phase of postmarketing surveillance, hypotension was added to the precautions section of the labelling in 1994. Cases...

Dapsone hypersensitivity syndrome.
March 22, 2000... Singapore -- A 22-year-old serviceman on an oversees training exercise in Brunei, received 100 mg dapsone and 12.5 mg pyrimethamine (Maloprim [R]) weekly as antimalarial chemoprophylaxis. Two weeks later, he developed fever which was...

Kava extract linked to hepatitis.
March 22, 2000... Switzerland -- The Intercantonal Office for the Control of Medicines has received information on a case of hepatitis following administration of Kava extract (Piper methysticum). Physicians and pharmacists are reminded that symptoms such as...

Gene therapy and patient protection.
March 22, 2000... United States of America -- The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have announced two initiatives to strengthen safeguards for individuals enrolled in clinical studies involving gene therapy. The...

WHO Model Prescribing Information.
March 22, 2000... Streptococcal pharyngitis and prevention of rheumatic fever Rheumatic fever and rheumatic heart disease are the delayed consequence of an untreated group A beta-haemolytic streptococcal infection of the upper respiratory tract. The disease...

BENZATHINE BENZYLPENICILLIN.
March 22, 2000... Powder for injection 1.44 g (2.4 million IU) in 5-ml vial Benzylpenicillin is a natural substance derived from Penicillium notatum. It is a bactericidal agent against streptococci, neisseriae, many anaerobes and spirochaetes. After...

PHENOXYMETHYLPENICILLIN.
March 22, 2000... Tablet, 250 mg, 500 mg (as potassium) Powder for oral suspension, 250 mg, 125 mg (as potassium salt)/5 ml Phenoxymethylpenicillin is a semisynthetic derivative of penicillin for oral use. It is active against a wide variety of Gram-positive...

ERYTHROMYCIN.
March 22, 2000... Enteric coated tablets, 250 mg (as stearate or ethylsuccinate) Oral suspension, 125 mg (as stearate or ethylsuccinate)/5 ml Erythromycin is a macrolide antimicrobial produced by Streptomyces erythreus. It has selective bacteriostatic...

SULFADIAZINE or SULFISOXAZOLE.
March 22, 2000... Tablet, 500 mg Injection, 250 mg (sodium salt) Sulfadiazine and sulfisoxazole are intermediate-acting sulfonamides with broad spectrum activity against a wide range of Gram-positive and Gram-negative organisms. They are readily...

Emergency contraception.
March 22, 2000... Emergency contraception will only have an impact on reducing unwanted pregnancies if women are provided with information and access to the methods available before they are needed. Emergency Contraception: A Guide for Service Delivery sets out...

UN Consolidated List: restrictions in use and availability.
March 22, 2000... An update of the pharmaceutical section of the Sixth Issue of the United Nations Consolidated List of Products whose Consumption and/or Sale have been Banned, Withdrawn, Severely Restricted or Not Approved by Governments has now been compiled....

New antituberculosis drug development.
March 22, 2000... Only one new antituberculosis drug has come to the market in the last 28 years despite nearly 2 million deaths from the disease occurring each year. A new report from the UNDP/World Bank/WHO Special Programme for Research and Training in...

Carcinogenic risks from antiviral and antineoplastic drugs.
March 22, 2000... The Seventy-Sixth volume of the International Agency for Research on Cancer (IARC) Monographs comprises evaluations of pharmaceutical agents which include antivirals (aciclovir, zidovudine, zalcitabine and didanosine), some DNA topoiso-merase...

HIV preventive vaccine research: ethical considerations.
March 22, 2000... The HIV pandemic is characterized by unique biological, social and geographical factors that affect the balance of risks and benefits for individuals and communities who participate in HIV vaccine development activities. These factors may...

International Nonproprietary Names for Pharmaceutical Substances (INN).
March 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 list on the following pages are under...