WHO Drug Information articles from September 2008

WHO Drug Information archives from September 2008

ICDRA: medicines agencies decide future action.(International Harmonization)
September 22, 2008... The Thirteenth International Conference of Drug Regulatory Authorities (ICDRA) held in Berne, Switzerland, from 16 to 19 September 2008 has once again provided drug regulators with a unique opportunity to meet and discuss the particular...

ICH-Q11 appears on the horizon: development and manufacture of drug substances.(International Harmonization)(Conference news)
September 22, 2008... The US Food and Drug Administration (FDA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) hosted an ICH Quality satellite round table in Rockville, Maryland, USA 27-28 September 2007. The objectives of the meeting were: ...

Strategies for developing pharmacovigilance: an international focus.(Pharmacovigilance Update)(Conference news)
September 22, 2008... The 8th International Society of Pharmacovigilance (ISoP) conference, Strategies for developing Pharmacovigilance, held in Buenos Aires, Argentina, in October 2008 was hosted by the Argentine Society of Pharmacovigilance. This was the first...

Harmonization and pharmacovigilance.(Pharmacovigilance Update)
September 22, 2008... The international harmonization of pharmacovigilance has an impact on drug licensing and utilization and on the health and disease burden worldwide, but its impact is greatest within trade alliances, like Mercosur or the European Union. The...

Counterfeit and substandard medicines.(Pharmacovigilance Update)
September 22, 2008... The ISoP session Counterfeit Medicines and i/legitimate Drugs tackled the growing problem of counterfeit and substandard medicines. The World Health Organization defines a counterfeit medicine as "a medicine which is deliberately and...

Better medicines for children: the way forward.(Access to Medicines)(Conference news)
September 22, 2008... Every second year, the World Health Organization (WHO) convenes the International Conference of Drug Regulatory Authorities (ICDRA). The ICDRAs provide drug regulatory authorities with a regulators-only forum to meet and discuss ways to...

Erlotinib: hepatic failure and hepatorenal syndrome.(Safety and Efficacy Issues)
September 22, 2008... United States of America -- Healthcare professionals have been informed of cases of hepatic failure and hepatorenal syndrome, including fatalities, reported during use of erlotinib (Tarceva[R]), particularly in patients with baseline hepatic...

Botulinum toxin type A and distant toxin spread.(Safety and Efficacy Issues)
September 22, 2008... Canada -- Botulinum toxin health products have recently been the subject of safety notices because of their suspected association with the potential spread of the toxin to sites in the body distant from the sites of administration (distant or...

Safety review of bisphosphonates.(Safety and Efficacy Issues)
September 22, 2008... United States of America -- On 1 October 2007, the Food and Drug Administration (FDA) announced that it was reviewing safety data on a potential increased risk for atrial fibrillation in patients treated with a bisphosphonate drug (1). ...

Ergot-derived dopamine agonists: fibrotic reactions.(Safety and Efficacy Issues)
September 22, 2008... United Kingdom/European Union -- The European Medicines Agency (EMEA) has recommended new warnings and contraindications for ergot-derived dopamine agonists as a result of the risk of fibrosis, particularly cardiac fibrosis, associated with...

Use of antibiotics in premature labour.(Safety and Efficacy Issues)(Brief article)
September 22, 2008... United Kingdom -- In the ORACLE Children Study (a 7-year follow-up of a large randomized, placebo controlled trial to investigate the effects of erythromycin and co-amoxiclav in premature labour) parents reported small increases in the number...

Intravenous immune globulin: transfusion-related lung injury.(Safety and Efficacy Issues)
September 22, 2008... Canada -- Transfusion-related acute lung injury (TRALI) is a clinical syndrome that presents as acute hypoxaemia and noncardiogenic pulmonary oedema during or within 6 hours after blood transfusion (1,2). TRALI is an important cause of...

Alemtuzumab: infection-related deaths.(Safety and Efficacy Issues)
September 22, 2008... Canada -- Health Canada has informed health-care professionals of important safety information regarding the use of alemtuzumab (Mabcampath[R]) as consolidation therapy following combination treatment with other chemotherapeutic or biologic...

Theophylline: narrow therapeutic index and potential for misuse.(Safety and Efficacy Issues)
September 22, 2008... United Kingdom -- Several products that contain theophylline or aminophylline are available as pharmacy medicines that can be dispensed without a prescription. Theophylline--a bronchodilator--interacts with several medicines and has a narrow...

Cesium chloride and ventricular arrhythmias.(Safety and Efficacy Issues)
September 22, 2008... Canada -- Nonradioactive cesium chloride (CsCI) is used orally as a natural health product. Although not authorized for therapeutic use in Canada, unauthorized cesium products are accessible for purchase (e.g., on the Internet) and are used for...

Drug-induced hyponatraemia.(Safety and Efficacy Issues)
September 22, 2008... Australia -- The Australian Adverse Drug Reactions Committee (ADRAC) continues to receive reports of hyponatraemia (1) in association with various medicines. Severe hyponatraemia is a potentially devastating condition that can develop rapidly...

Slimming health products adulterated with sibutramine.(Safety and Efficacy Issues)
September 22, 2008... Singapore -- In recent months, the Pharmacovigilance Branch of the Health Sciences Agency has received three reports of adverse drug reactions (ADR) associated with two slimming health products. On further investigation, the products namely,...

Phenytoin and fosphenytoin: serious skin reactions.(Safety and Efficacy Issues)
September 22, 2008... United States of America -- The Food and Drug Administration (FDA) is investigating new preliminary data regarding a potential increased risk of serious skin reactions including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis...

Etoricoxib: hypertension risks.(Safety and Efficacy Issues)
September 22, 2008... United Kingdom/European Union -- Health-care professionals have previously been informed of the risk of hypertension-related adverse events associated with use of etoricoxib, and of the contraindication for use of etoricoxib in patients with...

Efalizumab: updated labelling.(Safety and Efficacy Issues)
September 22, 2008... United States of America -- The Food and Drug Administration (FDA) has announced labelling changes to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), with the use of efalizumab...

Oseltamivir: hepatic and skin disorders.(Safety and Efficacy Issues)
September 22, 2008... World Health Organization -- The antiviral agent oseltamivir is a selective inhibitor of influenza virus A and B neuraminidase. It is indicated for the treatment and prophylaxis of influenza virus infection types A and B although vaccination is...

Rimonabant: suspension of marketing authorization.(Regulatory Action and News)(Brief article)
September 22, 2008... United Kingdom/European Union -- The European Medicines Agency (EMEA) has completed a review of rimonabant (Acomplia[R]), a treatment for obesity, after concerns about its psychiatric safety. The review has found that the benefits of rimonabant...

Vaccines for use in the 2009 influenza season.(Regulatory Action and News)
September 22, 2008... World Health Organization--It is recommended that vaccines for use in the 2009 influenza season (southern hemisphere winter) contain the following: * an A/Brisbane/59/2007 (H1N1)-like virus [A/South Dakota/6/2007 (an A/Brisbane/...

Australian Adverse Drug Reaction Committee (ADRAC) to be replaced.(Regulatory Action and News)
September 22, 2008... Australia -- The Australian Adverse Drug Reaction Committee (ADRAC) is to be abolished and a new committee set up to take a more pro-active approach to drug safety and post-marketing surveillance of medicines. ADRAC will be replaced by a...

50th orphan medicine receives positive opinion.(Regulatory Action and News)
September 22, 2008... European Union -- Efforts in combating rare diseases reached a new milestone this October, with the 50th positive opinion on an orphan medicine being adopted by the EMEA's Committee for Medicinal Products for Human Use (CHMP). To date, a...

Telavancin: withdrawal of marketing authorization application.(Regulatory Action and News)(Brief article)
September 22, 2008... European Union -- The European Medicines Agency (EMEA) has been formally notified of the decision to withdraw the application for a centralized marketing authorization for the medicinal product telavancin (Vibativ[R]) 15 mg/ml powder for...

Docetaxel: no extension of indication.(Regulatory Action and News)
September 22, 2008... European Union -- The European Medicines Agency (EMEA) has been notified by the manufacturer of its decision to withdraw the application for an extension of indication for the centrally authorized medicines containing docetaxel (Taxotere[R] 20...

Ciclosporin eye drops: withdrawal of marketing authorization application.(Regulatory Action and News)
September 22, 2008... European Union -- The European Medicines Agency (EMEA) has been formally notified by the manufacturer of withdrawal of the application for a centralized marketing authorization for the medicine ciclosporin 0.05% eye drops (Vekacia[R])....

Positive opinions on paediatric investigation plans.(Regulatory Action and News)
September 22, 2008... European Union -- A paediatric investigation plan (PIP) sets out a programme for the development of a medicine in the paediatric population. The PIP aims to generate the necessary quality, safety and efficacy data through studies to support the...

Biosimilar products: a regulatory update.(Regulatory Action and News)
September 22, 2008... Singapore -- A biosimilar medicine is a medicinal product which is similar to a biological medicine that has already been registered with a drug regulatory authority and is submitted for medicinal product registration by an independent...

ATC/DDD classification (temporary).(ATC/DDD Classification)(anatomical therapeutic chemical)(defined daily doses )(Table)
September 22, 2008... ATC/DDD Classification (Temporary) The following anatomical therapeutic chemical (ATC) classifications and defined daily doses (DDDs) were agreed by the WHO International Working Group for Drug Statistics Methodology in 27-28 October...

ATC/DDD classification (final).(ATC/DDD Classification)(anatomical therapeutic chemical)(defined daily doses )(Table)
September 22, 2008... ATC/DDD Classification (Final) The following anatomical therapeutic chemical (ATC) classifications and defined daily doses (DDDs) were agreed by the WHO International Working Group for Drug Statistics Methodology in March 2008. They...

FIP and the future of hospital pharmacy.(Recent Publications, Information and Events)
September 22, 2008... The Global Conference on the Future of Hospital Pharmacy was convened as part of the 68th Annual Congress of the International Pharmaceutical Federation (FIP). Hospital pharmacists from around the world met 30-31 August 2008 in Basel,...

Assessing, monitoring and evaluating pharmaceutical situations.(Recent Publications, Information and Events)
September 22, 2008... Pharmaceutical sector assessment allows the monitoring and evaluation of access to essential medicines, safety, effectiveness and good quality, and proper use. The WHO Operational package for assessing, monitoring and evaluating country...

European Pharmaceutical Forum success.(Recent Publications, Information and Events)
September 22, 2008... The final report of the Pharmaceutical Forum was presented on 18 October 2008 in Brussels setting out principles and recommendations on three key challenges in the pharmaceutical sector. Firstly, how to improve information on diseases and...

Procurement and supply management toolbox.(Recent Publications, Information and Events)
September 22, 2008... Since the Procurement & Supply Management Toolbox web site went live in December 2007, 27 new tools have been added making a total of 116 English tools. A separate toolbox has now been developed in French and contains 27 tools. The...

Report on essential medicines for children.(Recent Publications, Information and Events)
September 22, 2008... A draft report of the meeting of the Second Subcommittee on Selection and Use of Essential Medicines for Children, including the draft second Model List of Essential Medicines for Children has now been published as an agenda paper for the March...

Uganda's antimalarials market.(Recent Publications, Information and Events)(Brief article)
September 22, 2008... The Medicines for Malaria Venture (MMV) has just released a new report mapping the antimalarials market in Uganda. The report highlights a new focus in gathering an evidence base about the structure and size of the antimalarials market in order...

Right to access to medicines.(Recent Publications, Information and Events)
September 22, 2008... A resolution calling on the African Commission on Human and Peoples' Rights to recognize the human right to access for needed medicines was passed at a meeting of African Human Rights organizations in Abuja, Nigeria, on 10 November 2008. ...

New issue of WHO/HAI pricing bulletin.(Recent Publications, Information and Events)
September 22, 2008... In September, the United Nations Millennium Development Goals (MDG) Gap Task Force reported that medicines are too costly and availability is often poor. The lead article in the WHO/HAI Pricing Bulletin outlines key findings in the UN report,...

International Nonproprietary Names for Pharmaceutical Substances (INN)/Denominations communes internationales des Substances pharmaceutiques (DCI)/Denominaciones Comunes Internacionales para las Sustancias Farmaceuticas (DCI).
September 22, 2008... 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...

Proposed International Nonproprietary Names: List 100/Denominations communes internationales proposees: Liste 100/Denominaciones Comunes Internacionales Propuestas: Lista 100.
September 22, 2008... Comments on, or formal objections to, the proposed names may be forwarded by any person to the INN Programme of the World Health Organization within four months of the date of their publication in WHO Drug Information, i.e., for List 100 ...

Procedure for the selection of recommended international nonproprietary names for pharmaceutical substances/Procedure a suivre en vue du choix de denominations communes internationales recommandees pour les substances pharmaceutiques/Procedimiento de seleccion de denominaciones comunes internacionales recomendadas para sustancias farmaceuticas.(Annex 1)
September 22, 2008... The following procedure shall be followed by the World Health Organization (hereinafter also referred to as "WHO") in the selection of recommended international nonproprietary names for pharmaceutical substances, in accordance with...

General principles for guidance in devising international nonproprietary names for pharmaceutical substances/Directives generales pour la formation de denominations communes internationales applicables aux substances pharmaceutiques/Principios generales de orientacion para formar denominaciones comunes internacionales para sustancias farmaceuticas.(ANNEX 2)
September 22, 2008... 1. International Nonproprietary Names (INN) should be distinctive in sound and spelling. They should not be inconveniently long and should hot be liable to confusion with names in common use. 2. The INN for a substance belonging to a group...