WHO Drug Information articles from January 1 2009

WHO Drug Information archives from January 1 2009

WHO medicines prequalification: progress in 2008.(Quality of Medicines)(Report)
January 1, 2009... The WHO Prequalification Programme for Medicines (PQP) was initiated in 2001 as a service provided by the World Health Organization (WHO) to facilitate access to medicines that meet unified international standards of quality, safety and...

WHO Congress on Traditional Medicine and the Beijing declaration.(Herbal and Traditional Medicines)(Report)
January 1, 2009... Representatives of over 70 Member States attended the first WHO Congress on Traditional Medicine held on 7-9 November 2008 in Beijing, China. Satellite symposia were held to discuss related technical topics. Presentations were given by...

Global norms and standards for biological quality, safety and efficacy.(Biomedicines Update)(Company overview)
January 1, 2009... WHO Expert Committee on Biological Standardization Established in 1947, the Expert Committee on Biological Standardization (ECBS) is one of the longest standing World Health Organization (WHO) committees and has overall responsibility for...

The mobile laboratory: a new concept in medicines surveillance.(Safety of Medicines)
January 1, 2009... According to the World Health Organization (WHO), about 6 to 10% of medicines worldwide are counterfeit; a market worth 32 billion US dollars in annual sales. The phenomenon has grown in recent years due to methods of counterfeiting becoming...

Monitoring the safety of off-label medicine use.(Pharmacovigilance Focus)
January 1, 2009... Medicine labels contain important information on the conditions of use. These conditions typically include the indication, dosage, frequency of administration, and route of administration. Other important conditions of use can include the age...

Drotrecogin alfa: what relation to thrombosis?(Pharmacovigilance Focus)
January 1, 2009... Drotrecogin alfa (activated) is a recombinant form of human activated protein C that has antithrombotic, anti-inflammatory and profibrinolytic activities. It is used mainly in intensive care as a treatment for severe sepsis (sepsis associated...

Genetic basis of adverse drug events.(Safety and Efficacy Issues)(Report)
January 1, 2009... United States of America -- The first data offering health care professionals a better Look into the genetic basis of certain types of adverse drug events has been released by the Food and Drug Administration (FDA) and the International...

Anaesthetic infusion with pain pumps: articular chondrolysis.(Safety and Efficacy Issues)
January 1, 2009... Canada -- Postoperative pain pumps are infusion devices designed to continuously deliver controlled amounts of medication (1,2). They can be used to infuse local anaesthetic solutions directly into operative sites for pain management...

Atomoxetine: serious liver injury.(Safety and Efficacy Issues)
January 1, 2009... United States of America -- The Food and Drug Administration (FDA) continues to receive reports of serious liver injury in patients given atomoxetine. Atomoxetine received FDA approval on 26 November 2002 as the first non-stimulant medication...

Drotrecogin alfa: ongoing safety review.(Safety and Efficacy Issues)
January 1, 2009... United States of America -- The Food and Drug Administration (FDA) is aware of a retrospective study (1) which has reported an increased risk of serious bleeding events and death in patients with sepsis (a severe illness related to a...

Clopidogrel bisulfate: ongoing safety review.(Safety and Efficacy Issues)
January 1, 2009... United States of America -- The Food and Drug Administration (FDA) is aware of published reports that clopidogrel (Ptavix[R]) is less effective in some patients than it is in others. Differences in effectiveness may be due to genetic...

Modafinil: adverse skin and psychiatric reactions.(Safety and Efficacy Issues)
January 1, 2009... Australia -- Modafinil (Modavigil[R]) is a wakefulness promoting agent available since July 2002 for the treatment of patients with excessive daytime sleepiness associated with narcolepsy or chronic shift work sleep disorder and as adjunctive...

Levothyroxine update.(Safety and Efficacy Issues)
January 1, 2009... New Zealand -- Four brands of levothyroxine have Ministerial consent for distribution in New Zealand. These brands are Eltroxin[R], Synthroid[R], Goldshield Levothyroxine[R], and Eutroxsig[R]. Prescribers are reminded that the different...

Temsirolimus: hypersensitivity.(Safety and Efficacy Issues)
January 1, 2009... United Kingdom/European Union -- Hypersensitivity/infusion reactions (including some life-threatening and rare fatal reactions) have been associated with the administration of temsirolimus (Torisel[R]). These include but are not limited to...

Aliskiren: new contraindication and warning.(Safety and Efficacy Issues)(Brief article)
January 1, 2009... European Union -- The European Medicines Agency (EMEA) has recommended adding a contraindication to the product information for aliskiren, stating that it must not be used in patients who have experienced angioedema when taking aliskiren in...

Continued vaccination with Gardasil[R].(Safety and Efficacy Issues)
January 1, 2009... European Union -- The European Medicines Agency (EMEA) has reviewed the available information on the two cases of status epilepticus with myoclonus (repeated and prolonged seizures and loss of consciousness) reported in two girls vaccinated...

Erlotinib: use in hepatic impairment and advanced solid tumours.(Safety and Efficacy Issues)
January 1, 2009... Canada -- Erlotinib (Tarceva[R]) is a human epidermal growth factor receptor type 1/epidermal growth factor receptor (HER1/EGFR) tyrosine kinase inhibitor. It is authorized as monotherapy for the treatment of patients with locally advanced or...

Generic piperacillin and tazobactam: medication errors.(Safety and Efficacy Issues)
January 1, 2009... United Kingdom -- Generic versions of piperacillin/tazobactam are now available. These medicines have a different formulation and different compatibilities compared to the brand leader product (Tazocin[R]) which was reformulated last year....

Safety of artemisinin combination therapy for pregnant women.(Safety and Efficacy Issues)
January 1, 2009... A trial conducted in northwest Thailand has found that it is safe to use artemisinin combination therapy (ACT) to treat pregnant women with malaria, but that efficacy is inferior to single-drug artesunate treatment. The study, published in...

Efalizumab: suspension of marketing authorization.(Regulatory Action and News)
January 1, 2009... European Union -- The European Medicines Agency (EMEA) has recommended suspension of the marketing authorization for efalizumab (Raptiva[R]). The EMEA's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of...

Contusugene ladenovec: withdrawal of marketing application.(Regulatory Action and News)(Brief article)
January 1, 2009... European Union -- The European Medicines Agency (EMEA) has been formally notified by Gendux Molecular Limited of its decision to withdraw its application for a centralized marketing authorization for the medicinal product contusugene...

Paliperidone: withdrawal of application for extension of indication.(Regulatory Action and News)
January 1, 2009... European Union -- The European Medicines Agency (EMEA) has been formally notified by Janssen-Cilag International N.V. of its decision to withdraw its application for an extension of indication for the centrally authorized medicine...

First EMEA meeting of Committee for Advanced Therapies.(Regulatory Action and News)(Report)
January 1, 2009... European Union -- On 15 and 16 January, the European Medicines Agency (EMEA) held its first meeting of the new Committee for Advanced Therapies (CAT). The CAT is a multidisciplinary committee, gathering together some of the best available...

The International Pharmacopoeia.(Consultation Document)
January 1, 2009... OXYTOCINUM OXYTOCIN Draft proposal for the International Pharmacopoeia (January 2009). Please address any comments to Quality Assurance and Safety: Medicines, World Health Organization, 1211 Geneva 27, Switzerand. Fax +4122791...

Oxytocinum injectio oxytocin injection.(Consultation Document)
January 1, 2009... Draft proposal for the International Pharmocopoeia (January 2009). Please address any comments to Quality Assurance and Safety: Medicines, World Health Organization, 1211 Geneva 27, Switzerand. Fax +4122791 4730 or e-mail to...

Low availability, high prices keep essential medicines out of reach.(Recent Publications, Information and Events)
January 1, 2009... World Health Organization--An alarming lack of availability of essential medicines in the public sector drives patients to pay higher prices in the private sector or go without, according to a WHO study reported The Lancet. The results...

Sources and prices of selected medicines for children.(Recent Publications, Information and Events)
January 1, 2009... Formulations suitable for children (paediatric formulations) are often not available in the market place, for many reasons, including insufficient information on sources and prices. In May 2007 the World Health Assembly endorsed the WHO...

Two international summer courses in the Netherlands.(Recent Publications, Information and Events)
January 1, 2009... The Division of Pharmacoepidemiology and Pharmacotherapy at Utrecht University, the Netherlands, is offering two challenging international summer courses in Pharmacoepidemiology and Drug Safety and Pharmaceutical Policy Analysis (in...

Global politics of pharmaceutical monopoly.(Recent Publications, Information and Events)
January 1, 2009... This new book explains why the twin challenges of high medicines cost and the absence of appropriate or effective treatments for many of the diseases affecting patients are in fact two sides of the same coin. It analyses the latest mechanisms...

International Nonproprietary Names for pharmaceutical substances (INN)/Denominations communes internationales des Substances pharmaceutiques (DCI)/Denominaciones Comunes Internacionales para las Sustancias Farmaceuticas (DCI).
January 1, 2009... RECOMMENDED International Nonproprietary Names: List 61 Notice is hereby given that, in accordance with paragraph 7 of the Procedure for the Selection of Recommended International Nonproprietary Names for Pharmaceutical Substances [Off....