WHO Drug Information articles from March 2006

WHO Drug Information archives from March 2006

Drug regulation in 2006: vision and challenges.(Regulatory Issues)(International Conference of Drug Regulatory Authorities)
March 22, 2006... The Twelfth International Conference of Drug Regulatory Authorities (ICDRA) held in Seoul, Republic of Korea, from 3 to 6 April 2006 has once again provided drug regulators with a unique opportunity to meet and discuss the particular...

Tenofovir and nonsteroidal anti-inflammatories: acute renal failure.(Safety and Efficacy Issues)
March 22, 2006... Canada -- Tenofovir disoproxil fumarate (Viread[R]) is an antiretroviral indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents in patients 18 years of age and older (1). Tenofovir was marketed on 15...

Update on status of contraceptive skin patch.(Safety and Efficacy Issues)
March 22, 2006... Canada -- The results of two studies looking at the risk of serious side effects when using the Ortho Evra[R] contraceptive patch marketed in the United States are currently being reviewed. The version of Evra[R] marketed in Canada is...

SSRI antidepressants linked to lung disorder in newborns.(Safety and Efficacy Issues)
March 22, 2006... Canada -- Generally, selective serotonin reuptake inhibitor (SSRI) treatment should only be continued during pregnancy if the benefits to the individual patient are thought to outweigh the risks to the unborn child, while also considering the...

ACE inhibitors and birth defects.(Safety and Efficacy Issues)
March 22, 2006... Use of angiotensin-converting--enzyme (ACE) inhibitors during the second and third trimesters of pregnancy is contraindicated because of their association with an increased risk of fetopathy. In contrast, first-trimester use of ACE inhibitors...

ACE inhibitors and pregnancy.(Safety and Efficacy Issues)
March 22, 2006... United States of America -- The New England Journal of Medicine (see above) has published an article reporting that infants whose mothers had taken an angiotensin-converting enzyme inhibitor (ACE inhibitor) during the first trimester of...

Gadolinium-containing contrast agents and nephrogenic systemic fibrosis.(Safety and Efficacy Issues)
March 22, 2006... United States of America -- The Food and Drug Administration (FDA) is evaluating important safety information about gadolinium-containing contrast agents and a disease known as nephrogenic systemic fibrosis or nephrogenic fibrosing dermopathy...

Gatifloxacin and blood glucose disturbances.(Safety and Efficacy Issues)
March 22, 2006... Singapore -- The Health Sciences Agency (HSA) would like to draw the attention of healthcare professionals to the known adverse effects of hypoglycaemia and hyperglycaemia associated with gatifloxacin (Tequin[R]), a fluoroquinolone...

WHO Model List of Essential Medicines and developed countries: a comparison with the Lothian Joint Formulary.(Essential Medicines)
March 22, 2006... Essential medicines lists and formularies are valuable public health tools which balance consideration of need, efficacy, safety and cost. The WHO Model List of Essential Medicines has been widely adopted or adapted in over 150 countries, and...

Adherence to WHO's Model List of Essential medicines in two European countries.(Essential Medicines)
March 22, 2006... The concept of Essential Medicines is one of the most important tools available for improving public health in developing countries and key elements include the WHO Model List of Essential Medicines (1,2). It has been proposed that developed...

Transgenic antithrombin alfa approved.(Regulatory Action and News)
March 22, 2006... European Union -- The European Medicines Agency (EMEA) has adopted the first positive opinion for a medicinal product derived from transgenic biotechnology. ATryn[R], contains antithrombin alfa, a recombinant-DNA human anti-clotting blood...

EMEA Management Board moves for greater transparency.(Regulatory Action and News)(European Medicines Agency)(Brief article)
March 22, 2006... European Union -- Transparency was the main topic for discussion of the European Medicines Agency's Management Board at its 6 June 2006 meeting. The Board agreed in principle to publish its meeting agendas and minutes, together with all...

Bupropion approved for seasonal depression.(Regulatory Action and News)
March 22, 2006... United States of America -- The Food and Drug Administration (FDA) today approved bupropion HCL extended release tablets (Wellbutrin XL[R] for prevention of major depressive episodes in patients with a history of seasonal affective disorder...

Decitabine approved for myelodysplastic syndromes.(Regulatory Action and News)
March 22, 2006... United States of America -- The Food and Drug Administration (FDA) has approved decitabine (Dacogen) injection for the treatment of myelodysplastic syndromes (MDS). Dacogen is a new molecular entity that has received orphan drug status. ...

Medical device innovation initiative.(Regulatory Action and News)
March 22, 2006... United States of America -- The Food and Drug Administration (FDA) is launching the Medical Device Innovation Initiative to make new medical devices available more quickly for patients. This broad initiative will promote early interaction...

Topotecan/cisplatin for late-stage cervical cancer.(Regulatory Action and News)
March 22, 2006... United States of America -- The Food and Drug Administration (FDA) has approved a combination of topotecan hydrochloride (Hycamtin[R]) and cisplatin for use as the first drug treatment for women with late-stage cancer of the cervix when a...

Rapid approval of vaccine for prevention of cervical cancer.(Regulatory Action and News)
March 22, 2006... United States of America -- The Food and Drug Administration (FDA) has announced the approval the first vaccine developed to prevent cervical cancer, precancerous genital lesions and genital warts due to human papillomavirus (HPV). The...

Rasagiline approved for Parkinson disease.(Regulatory Action and News)
March 22, 2006... United States of America -- The Food and Drug Administration has approved rasagiline (Azilect[R]), a new molecular entity, for the treatment of Parkinson disease. The drug is a monoamine oxidase type--B (MAO-B) inhibitor that blocks the...

Fluoxetine approved for children and adolescents.(Regulatory Action and News)
March 22, 2006... European Union -- The European Medicines Agency (EMEA) has recommended to extend the indication for fluoxetine (Prozac[R]) and associated names to include the treatment of children of 8 years of age or older who suffer from moderate to...

Withdrawal of marketing application for Surfaxin[R].(Regulatory Action and News)(Brief article)
March 22, 2006... European Union -- The European Medicines Agency has been formally notified by the manufacturer of the orphan medicinal product Surfaxin[R] of their decision to withdraw the application for a centralized marketing authorization. The active...

Resumed marketing of natalizumab.(Regulatory Action and News)
March 22, 2006... United States of America -- The Food and Drug Administration (FDA) has approved an application for resumed marketing of natalizumab (Tysabri[R]) subject to a special restricted distribution programme. Natalizumab is a monoclonal antibody used...

EU regulation on compulsory licensing published.(Regulatory Action and News)(licensing patents of pharmaceutical products)(Brief article)
March 22, 2006... The European Union regulation text on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems was published in the Official Journal of the EU on 9 June 2006....

Tissue infectivity and transmissible spongiform encephalopathies.(Emerging Diseases)
March 22, 2006... A variant form of a fatal brain disease, Creutzfeldt-Jakob disease (vCJD), was first identified in the mid-1990s as a result of suspected bovine spongiform encephalopathy (BSE) transmission to humans in the United Kingdom. Since then, cases...

ATC/DDD classification (temporary).(ATC/DDD Classification)(anatomical therapeutic chemical classifications and defined daily doses )(Chart)
March 22, 2006... 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 22-23 March 2006....

ATC/DDD classification (final).(ATC/DDD Classification)(anatomical therapeutic chemical classifications and defined daily doses )(Chart)
March 22, 2006... 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 October 2005 They...

Interagency emergency health kit 2006.(Recent Publications, Information and Events)
March 22, 2006... Over the years, the concept of the emergency health kit has been adopted by many organizations and national authorities as a reliable, standardized and quickly available source of essential medicines and medical devices (renewables and...

Therapeutic guidelines for rheumatology.(Recent Publications, Information and Events)(Brief article)
March 22, 2006... The Therapeutic Guidelines range has become well known internationally. The guidelines are independent, peer reviewed and regularly updated. Therapeutic Guidelines: Rheumatology, have just been released covering management of a wide range of...

Specifications for pharmaceutical preparations.(Recent Publications, Information and Events)(reports from WHO Expert Committee on Specifications for Pharmaceutical Preparations)(Brief article)
March 22, 2006... The WHO Expert Committee on Specifications for Pharmaceutical Preparations meets every two years. The following is a list of reports and guidelines included in the Fortieth report of the Expert Committee recently published by WHO. Annex...

New guidance for pharmacists on counterfeit medicines.(Recent Publications, Information and Events)
March 22, 2006... The Medicines and Healthcare Products Regulatory Agency (MHRA) and the Royal Pharmaceutical Society of Great Britain (RPSGB) have published new guidance for pharmacists which explains the causes and consequences of counterfeiting and provides...

Marketed unapproved drugs--policy guide.(Recent Publications, Information and Events)
March 22, 2006... For historical reasons, some drugs are available in the United States that lack required FDA approval for marketing. The new drug approval and OTC drug monograph processes play an essential role in ensuring that all drugs are both safe and...

WHO guidelines on avian influenza.(Recent Publications, Information and Events)
March 22, 2006... WHO guidelines on avian influenza have been developed based on a rapid review of available evidence. These are available on the WHO Website. Feedback on their usefulness would be very much appreciated, as they have been developed based...

WHO analgesic ladder.(Recent Publications, Information and Events)
March 22, 2006... An appraisal of the WHO Analgesic Ladder is the focus of the current issue of Cancer Pain Release, the publication of the WHO Pain and Palliative Care Communications Programme. The issue features an interview with Dr. Kathleen Foley, former...

Resources for paediatric formulations.(Recent Publications, Information and Events)
March 22, 2006... The British Neonatal and Paediatric Pharmacists Group has many useful links on their Website. Under the "Pharmaceutical links" category there is a "Formulation and stability database". The information in the database was gathered from...

International Pharmacopoeia: revision of monographs for antimalarials and draft proposals for antiretrovirals.(Consultation Document)
March 22, 2006... All monographs published in The International Pharmacopoeia on artemisin derivatives, (i.e. artemether, artemisinin, artemotil, and artenimol as active ingredients and dosage forms) have the same limits for the related substances tests (HPLC...

International Nonproprietary Names for Pharmaceutical Substances (INN).
March 22, 2006... 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...