WHO Drug Information articles from January 2004

WHO Drug Information archives from January 2004

Drug regulatory authorities recommend action.(Regulatory Challenges)
January 1, 2004... The Eleventh International Conference of Drug Regulatory Authorities (ICDRA) took place in Madrid, Spain from 16 to 19 February 2004. The ICDRA was hosted by the Ministry of Health of Spain and the Spanish Agency for Medicines and Health...

Treating 3 million people living with HIV/AIDS by 2005.(Essential Medicines)
January 1, 2004... The World Health Organization (WHO) has launched a 3 by 5 strategy to treat three million people with HIV by 2005. The strategy will reflect the highest public health standards and will leverage resources and synergize action among interested...

AIDS medicines and diagnostics service.(Essential Medicines)
January 1, 2004... The AIDS medicines and diagnostics service (AMDS) is a mechanism created to expand access to quality, effective treatment for HIV/AIDS by facilitating the increased supply of antiretrovirals (ARVs) and diagnostics in developing countries. The...

Fixed-dose combination therapy.(Essential Medicines)
January 1, 2004... WHO's Prequalification Project has added three new generic products for first-line HIV treatment to its list of medicines meeting WHO standards of quality, safety and efficacy. The products are fixed-dose triple therapy combinations...

HIV antiretrovirals and diagnostics funding.(Essential Medicines)
January 1, 2004... The Global Fund to Fight AIDS, Tuberculosis and Malaria, the World Bank, UNICEF and the Clinton Foundation have announced agreements that will make it possible for developing countries to purchase high-quality AIDS medicines and diagnostics...

World Bank ARV procurement manual.(Essential Medicines)
January 1, 2004... The Technical guide for HIV/AIDS medicines and related supplies: Contemporary context and procurement has been published by the World Bank. The Technical Guide was developed to address the specific requirements and unique features of the...

Research on new HIV microbicides.(Essential Medicines)
January 1, 2004... New antiviral agents are being developed by scientists and HIV experts from the UK Medical Research Council (MRC) and the Department for International Development (DFID). The antiviral properties of potential microbicides could work in a...

Safety of HIV therapies targeted by new advisory committee.(Safety and Efficacy Issues)
January 1, 2004... An Advisory Committee on Medicinal Product Safety has been established under the auspices of WHO to respond promptly and efficiently to medicines safety issues of potential global importance. The first meeting of the Committee was held from...

The risks and benefits of HRT.(Safety and Efficacy Issues)
January 1, 2004... The Women's Health initiative (WHI) study, a large randomized trial comparing combination hormone replacement therapy (HRT) to placebo, found that the increase in risk associated with long term therapy exceeded the benefits (1). In particular...

Macrolides and warfarin interaction.(Safety and Efficacy Issues)
January 1, 2004... The Australian Drug Evaluation Committee (ADRAC) has received reports of interactions between warfarin and all four macrolide antibiotics (azithromycin, clarithromycin, erythromycin, and roxithromycin) (see table below) (1). Although most...

Statin risk factors: myopathy and rhabdomyolysis.(Safety and Efficacy Issues)
January 1, 2004... Four statins (HMG CoA inhibitors) are available in Australia for the treatment of hypercholesterolaemia: simvastatin, atorvastatin, pravastatin and fluvastatin. Each of the statins may cause myalgia or rhabdomyolysis. Cerivastatin was removed...

Serotonin syndrome.(Safety and Efficacy Issues)
January 1, 2004... Serotonin syndrome is caused by excessive central nervous system and peripheral serotonergic activity. It most commonly occurs with a combination of serotonergic agents, but may also occur with a single agent. A combination of agents...

Antidepressants: worsening depression and suicidal behaviour.(Safety and Efficacy Issues)
January 1, 2004... The US Food and Drug Administration (FDA) has asked manufacturers to include a warning statement recommending close observation for worsening depression or the emergence of suicidality of adult and paediatric patients treated with the...

Use of SSRI antidepressants in children and adolescents.(Safety and Efficacy Issues)
January 1, 2004... The Australian Adverse Drug Reactions Advisory Committee (ADRAC) has considered the safety and efficacy of selective serotonin reuptake inhibitor (SSRI) antidepressants in children and adolescents. There is international concern about a...

Repaglinide and gemfibrozil interaction.(Safety and Efficacy Issues)
January 1, 2004... An interaction between repaglinide a short-acting secretagogue and gemfibrozil a lipid-lowering agent used to great dyslipidaemia has been reported (1) in the Volume 29 of Current problems in Pharmacovigilance (Committee on Safety of...

World's biological experts establish standards.(Vaccines and Biomedicines)
January 1, 2004... The WHO Expert Committee on Biological Standardization met in Geneva from 17 to 21 November 2003. The technical specifications and reagents developed by the Committee define international regulatory expectations for the quality, safety and...

International reference materials.(Vaccines and Biomedicines)
January 1, 2004... A list of new or replacement reference materials is given in Table 1. Details of selected reference materials are given below to illustrate the range of issues considered by the Committee. Yellow fever vaccine Potency determination...

Quality, safety and efficacy of biological medicines.(Vaccines and Biomedicines)
January 1, 2004... Wild poliovirus contamination of oral poliomyelitis vaccine In the period November 2002 to February 2003, several cases of poliomyelitis were observed in one country after vaccination and the MEF-1 reference wild-type poliovirus type 2...

Regulation of Traditional Medicines in Africa.(Herbal Medicines)
January 1, 2004... The majority of African populations use traditional medicine for their health care needs which is often bought in places such as open markets and local stores. Although many traditional medicines are claimed to cure various diseases,...

Herbal medicines, patient safety and plant conservation.(Herbal Medicines)
January 1, 2004... WHO has published guidelines for good agricultural and collection practices for medicinal plants intended for national governments, to ensure production of herbal medicines is of good quality, sale, sustainable and poses no threat to people...

Nevirapine and hepatotoxicity.(Regulatory and Safety Action)
January 1, 2004... Canada -- The manufacturer of nevirapine (Viramune[R]) has provided new safety information clarifying risk factors for severe, life-threatening and fatal hepatotoxicity. Nevirapine, a non-nucleoside reverse transcriptase inhibitor, is...

Antidepressants in adults and children.(Regulatory and Safety Action)
January 1, 2004... United States of America -- The Food and Drug Administration (FDA) has cautioned health care professionals and patients about the need to closely monitor adults and children treated for depression following reports suggesting an increased...

Recommended influenza vaccines: 2004-2005.(Regulatory and Safety Action)
January 1, 2004... World Health Organization -- The composition of influenza vaccines for the Northern hemisphere 2004-2005 Winter season has been determined as follows: * an A/New Caledonia/20/99(H1N1)-like virus * an A/Fjian/411/2002(H3N2)-like...

Olanzapine and cerebrovascular events.(Regulatory and Safety Action)
January 1, 2004... Canada -- The manufacturer of olanzapine (Zyprexa[R]) has circulated information pertaining to cerebrovascular adverse events that have occurred in elderly patients with dementia-related psychosis treated with olanzapine in clinical trials....

Olanzapine: hyperglycaemia and diabetes.(Regulatory and Safety Action)
January 1, 2004... United States of America --The Food and Drug Administration (FDA) has asked all manufacturers of atypical antipsychotic medications to add a warning statement describing the increased risk of hyperglycaemia and diabetes. The atypical...

Better labelling for ingredient sensitivities.(Regulatory and Safety Action)
January 1, 2004... United States of America -- The Food and Drug Administration (FDA) has published new rules on content labeling (amount present per dosage unit) and warning labeling for over-the-counter (OTC) drugs that contain levels of calcium, magnesium,...

The International Pharmacopoeia--monographs for antiretrovirals.(Consultation Document)
January 1, 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...

Indinavir sulfas indinavir sulfate.(Consultation Document)
January 1, 2004... Molecular formula: [C.sub.36][H.sub.49][N.sub.5][O.sub.8]S or [C.sub.36][H.sub.47][N.sub.5][O.sub.4], [H.sub.2][O.sub.4]S Relative molecular mass. 711.9 Graphic formula: [ILLUSTRATION OMITTED] Chemical name: (2S)-1-[(2S,...

Nelfinavir mesilas nelfinavir mesilate.(Consultation Document)
January 1, 2004... Molecular formula: [C.sub.32][H.sub.45][N.sub.3][O.sub.4]S, C[H.sub.4][O.sub.3]S Relative molecular mass: 663.9 Graphic formula: [ILLUSTRATION OMITTED] Chemical name:...

Nevirapinum anhydricum Nevirapine anhydrous.
January 1, 2004... Molecular formula: [C.sub.15][H.sub.14][N.sub.4]O Relative molecular mass: 266.30 Graphic formula: [ILLUSTRATION OMITTED] Chemical name: 11-cyclopropyl-4-methyl-5,11-dihydro-6H-dipyrido[3,2-b.2',3'-e] [1,4]diazepin-6-one CAS...

Proposed International Nonproprietary Names: list 90.(International Nonproprietary Names for Pharmaceutical Substances (INN))
January 1, 2004... 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...

Recommended International Nonproprietary Names: list 51.(International Nonproprietary Names for Pharmaceutical Substances (INN))
January 1, 2004... Notice is hereby given that, in accordance with paragraph 7 of the Procedure for the Selection of Recommended International Nonpropdetary Names for Pharmaceutical Substances [Off. Rec. W/d Health Org., 1955, 60, 3 (Resolution EB15.R7); 1969,...