WHO Drug Information articles from September 2007

WHO Drug Information archives from September 2007

Who celebrates thirty years of essential medicines.(Access to Essential Medicines)
September 22, 2007... Essential medicines are those medicines that address the priority health care needs of a given population. Selection is based on health relevance, quality, safety, efficacy and comparative cost-effectiveness. Essential medicines should be...

Estrogen therapy and symptoms of parkinsonism: a review using WHO's ADR data base.(Pharmacovigilance Focus)
September 22, 2007... It has long been known that fewer women are diagnosed with Parkinson disease than men. The seemingly protective effect offered to females against degenerative disease of the central nervous system may relate to estrogen, although the mechanism...

Perflutren injectable: serious cardiopulmonary reactions.(Safety and Efficacy Issues)
September 22, 2007... Canada -- Perflutren Injectable Suspension (Definity[R]) is an ultrasound contrast indicated for ultrasound imaging of cardiac structures (ventricular chambers and endocardial borders) and function (regional wall motion) in adult patients with...

Gefitinib: failure of overall survival vs docetaxel.(Safety and Efficacy Issues)
September 22, 2007... Canada -- The manufacturer of gefitinib (Iressa[R]) 250 mg tablets has informed healthcare professionals taking part in the Iressa[R] Patient Registry (IPR) of the failure to demonstrate non-inferiority in overall survival versus docetaxel. The...

Rituximab and progressive multifocal leukoencephalopathy.(Safety and Efficacy Issues)
September 22, 2007... Australia -- The Adverse Drug Reactions Advisory Committee (ADRAC) has received a report of the rare neurological disease, progressive multifocal leukoencephalopathy, associated with the use of rituximab (Mabthera[R]) (1). Rituximab is an...

Implanon[R]: interactions and contraceptive failure.(Safety and Efficacy Issues)
September 22, 2007... Australia -- Hepatic enzyme inducing medicines can reduce the efficacy of contraceptives, including implantable contraceptives, leading to unintended pregnancy. Medicare Australia data indicate that 370,173 etonogestrel-containing...

Atypical antipsychotic agents and extrapyramidal effects.(Safety and Efficacy Issues)
September 22, 2007... Australia -- It has been suggested that the atypical antipsychotic agents clozapine, risperidone, olanzapine, aripipazole and quetiapine may have lower propensity for causing extrapyramidal side effects (EPS) when compared with older...

Thiazolidinediones and reduced bone density.(Safety and Efficacy Issues)(Clinical report)
September 22, 2007... Australia -- Thiazolidinediones include rosiglitazone (Avandia[R] and Avandamet[R]) and pioglitazone (Actos[R]). These medicines act to increase insulin sensitivity and are widely prescribed to treat type II diabetes mellitus. Recent evidence...

Renal impairment with zoledronic acid.(Safety and Efficacy Issues)
September 22, 2007... Australia -- There is a well-known risk of deterioration in renal function with intravenous bi-sphosphonates administered at a rapid infusion rate. The Adverse Drug Reactions Advisory Committee (ADRAC) has received few reports of renal...

Epoetins: unexplained excess mortality.(Safety and Efficacy Issues)
September 22, 2007... European Union -- The European Medicines Agency (EMEA) has recently reviewed the safety of epoetins. These medicines are used for the treatment of anaemia in patients with chronic renal failure and for the treatment of patients with non-myeloid...

Contraindicated use of sibutramine and cardiovascular reactions.(Safety and Efficacy Issues)(Brief article)
September 22, 2007... Canada -- Sibutramine (Meridia[R]), a serotonin and norepinephrine reuptake inhibitor, is an antiobesity agent marketed in Canada since February 2001. Sibutramine is indicated as adjunctive therapy within a weight management programme for...

Gadolinium-containing contrast agents: nephrogenic systemic fibrosis.(Safety and Efficacy Issues)
September 22, 2007... Canada -- Gadolinium (Gd)-containing media are used to enhance the contrast of magnetic resonance images. Those authorized for sale in Canada include Magnevist[R], Omniscan[R], OptiMARK[R], Gadovist[R], ProHance[R], MultiHance[R] and Vasovist....

Swedish Adjustable Gastric Band: incidents leading to explantation.(Safety and Efficacy Issues)
September 22, 2007... Canada -- The Swedish Adjustable Gastric Band (SAGB) is an implantable, adjustable gastric band indicated for use in the treatment of morbid obesity in adults (1). It consists of a reinforced silicone gastric band fitted around the stomach and...

Influenza virus vaccines: Southern hemisphere 2008.(Regulatory Action and News)
September 22, 2007... World Health Organization--It is recommended that vaccines for use in the 2008 influenza season (Southern hemisphere winter) contain the following: * an A/Solomon Islands/3/2006 (H1N1)-like virus (A/Solomon Islands/3/2006 is a current...

Withdrawal of cough medicines containing clobutinol?(Regulatory Action and News)
September 22, 2007... European Union--Following a review of the safety of clobutinol-containing cough medicines (Silomat[R]), the European Medicines Agency (EMEA) has concluded that the risks of these medicines outweigh the benefits and has recommended that...

Rimonabant warning: psychiatric conditions.(Regulatory Action and News)(Brief article)
September 22, 2007... European Union--The European Medicines Agency (EMEA) has recommended contraindicating rimonabant (Acomplia[R]) in patients with ongoing major depression or who are being treated with antidepressants, because of the risk of psychiatric side...

United States of America--Rimonabant is a first in class cannabinoid receptor 1 (CB1) antagonist/inverse agonist for weight management.(Regulatory Action and News)(Brief article)
September 22, 2007... United States of America -- Rimonabant is a first in class cannabinoid receptor 1 (CB1) antagonist/inverse agonist for weight management. The Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee met on 13 June...

Lumiracoxib registration cancelled.(Regulatory Action and News)
September 22, 2007... Australia -- The Therapeutic Goods Administration (TGA) has cancelled the registration of the osteoarthritis drug, lumiracoxib (Prexige[R]) because of serious liver side effects associated with the use of the drug. Lumiracoxib is a cox-2...

Lumiracoxib: withdrawal of higher doses.(Regulatory Action and News)(Brief article)
September 22, 2007... New Zealand -- The Medicines and Medical Devices Safety Authority, Medsafe, has withdrawn supply of 200 mg and 400 mg tablets of the cox-2 anti-inflammatory medicine lumiracoxib (Prexige[R]). The decision has been reached after Medsafe...

Ixabepilone approved for advanced breast cancer.(Regulatory Action and News)
September 22, 2007... Unites States of America -- The Food and Drug Administration (FDA) has approved ixabepilone (Ixempra[R]), a new anti-cancer treatment, for use in patients with metastatic or locally advanced breast cancer who have not responded to certain other...

Second-generation smallpox vaccine approved.(Regulatory Action and News)
September 22, 2007... United States of America -- The Food and Drug Administration (FDA) has licensed a new vaccine to protect against smallpox, a highly contagious disease with the potential to be used as a deadly bioterror weapon. A worldwide vaccination...

Regulatory updates.(Regulatory Action and News)
September 22, 2007... European Union--A summary of recent regulatory developments is available from the European Commission. B.1.1.2 Notice to applicants for medicinal products for human use EudraLex Vol 2A, Chapter 3--Community Referral (for human medicinal...

Generic substitution in Jamaica: challenges to improved effectiveness.(Generic Medicines)
September 22, 2007... In 1993, an Amendment to the Pharmacy Act introduced generic substitution of innovator brands to Jamaica. Although the Amendment gives prescribers the opportunity to indicate "no substitution" on prescriptions, implementation of the generic...

Frequently asked questions about generic medicines.(Generic Medicines)
September 22, 2007... In Australia, generic products must be bioequivalent to the innovator brand name product, or the market leader, before they are approved. Australia has rigorous scientifically based evaluation procedures for generic medicines based on the...

Latest developments in ICH Quality.(Quality Assurance Update)(International Conference on Harmonisation )
September 22, 2007... The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) recently convened a Quality Satellite Roundtable at Rockville, Maryland, USA. During the Satellite, the Quality...

Oxytocinum Oxytocin.(International Pharmacopoeia)(Drug overview)
September 22, 2007... Draft proposal for the International Pharmocopoeia (September 2007). Please address any comments to Quality Assurance and Safety: Medicines, PSM, World Health Organization, 1211 Geneva 27, Switzerand. Fax +4122791 4730 or e-mail to rabhouansm...

Oxytocinum Injectio/Oxytocin Injection.(International Pharmacopoeia)
September 22, 2007... Draft proposal for the International Pharmocopoeia (October 2007). Please address any comments to Quality Assurance and Safety: Medicines, Medicines Policy and Standards, World Health Organization, 1211 Geneva 27, Switzerand. Fax +4122791 4730...

GMP for herbal medicines.(Recent Publications, Information and Events)
September 22, 2007... The safety and quality of herbal materials and finished herbal products have become a major concern for health authorities. Requirements and methods for quality control of finished herbal products are far more complex than for chemical drugs....

Quality of antiretrovirals in African countries.(Recent Publications, Information and Events)
September 22, 2007... In 2006, almost two-thirds of persons infected with HIV were living in Sub-Saharan Africa. Provision of antiretroviral treatment by both public and private sector facilities has increased tenfold between December 2003 and June 2006. The...

The Health Journey.(Recent Publications, Information and Events)(Brief article)
September 22, 2007... The Health Journey is a simple and useful participatory methodology for understanding the experiences of people living with HIV in trying to access and use health and other support services. It provides a starting point for planning and...

Human rights guidelines for pharmaceutical companies.(Recent Publications, Information and Events)
September 22, 2007... The UN Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, has launched for public consultation draft Human Rights Guidelines for Pharmaceutical Companies in relation to...

ARV price report from WHO.(Recent Publications, Information and Events)
September 22, 2007... The new summary report by the WHO/ AMDS Global Price Reporting Mechanism (GPRM) confirms that median prices of the most commonly prescribed antiretroviral medicines (ARVs) in fixed dose combination (stavudine 30 mg + lamivudine 150 mg +...

International Nonproprietary Names for Pharmaceutical Substances (INN)/Denominations communes Internationales des Substances Pharmaceutiques (DCI)/Denominaciones Comunes Internacionales para las Sustancias Farmaceuticas (DCI).
September 22, 2007... 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...

Amendments to previous lists/Modifications apportees aux listes anterieures/ Modificaciones a las listas anteriores.
September 22, 2007... Proposed International Non Proprietary Names (Prop. INN): List 56 (WHO Chronicle, Vol. 40, No. 5, 1986) p. 11 nebivololum nebivolol replace the CAS registry number by the following 118457-14-0 ...