WHO Drug Information articles from March 2007

WHO Drug Information archives from March 2007

Entecavir: not for use in HIV/HBV co-infection.(Safety and Efficacy Issues)
March 22, 2007... European Union -- The Committee for Medicinal Products for Human Use (GHMP) reminds healthcare professionals that entecavir (Baraclude[R]) has not been evaluated for the treatment of patients with chronic hepatitis B virus (HBV) infection who...

Deferasirox: acute renal failure and cytopenias.(Safety and Efficacy Issues)
March 22, 2007... Canada -- The manufacturer of deferasirox (Exjade[R]) has updated the safety information regarding reports of acute renal failure and peripheral blood cytopenias. Deferasirox is indicated in the management of chronic iron overload in...

Safety of oseltamivir.(Safety and Efficacy Issues)
March 22, 2007... European Union -- The European Medicines Agency (EMEA) has documented new reports of neuropsychiatric adverse events occurring with the use of oseltamivir (Tamiflu[R]) originating from Japan. These cases have been detected through routine...

Fluticasone: reports of behavioural changes.(Safety and Efficacy Issues)
March 22, 2007... Netherlands -- The Netherlands Pharmacovigilance Centre, Lareb, has received 17 reports of behavioural changes in children associated with the use of inhaled fluticasone propionate or salmeterol/fluticasone propionate (4). In 11 cases, symptoms...

Quetiapine: pancreatitis and thrombocytopenia.(Safety and Efficacy Issues)
March 22, 2007... Canada -- Quetiapine (Seroquel[R]) is an atypical antipsychotic drug indicated for the management of symptoms of schizophrenia and the acute management of manic episodes associated with bipolar disorder (1). In Canada, quetiapine has been...

Aprotinin: hypersensitivity reactions and renal dysfunction.(Safety and Efficacy Issues)
March 22, 2007... Canada -- Health Canada has informed hospitals and pharmacies of an association of aprotinin (Trasylol[R]) with hypersensitivity reactions and renal dysfunction. Aprotinin is indicated for prophylactic use to reduce perioperative blood loss and...

Metoclopramide in children: extrapyramidal symptoms.(Safety and Efficacy Issues)
March 22, 2007... Netherlands -- Following an increase in the number of registered cases of extrapyramidal symptoms in children receiving metoclopramide, the Medicines Evaluation Board has restricted the use of metoclopramide in this population to treatment of...

Drug-eluting stents: to be used with caution.(Safety and Efficacy Issues)(Clinical report)
March 22, 2007... Sweden -- The Swedish Medical Products Agency (MPA), in conjunction with the National Board of Health and Welfare and the Swedish Society of Cardiology, has recommended utmost restraint in the use of drug-eluting stents. The recommendation was...

Darbepoetin alfa and epoetin alfa: update for non-myeloid malignancies.(Safety and Efficacy Issues)(Clinical report)
March 22, 2007... Canada -- The manufacturers of the erythropoiesis-stimulating agents (ESAs), have updated safety information based on completed or ongoing clinical studies regarding treatment with darbepoetin alfa (Aranesp[R]) and epoetin alfa (Eprex[R]). ...

Ayurvedic and Chinese medicines: heavy metals.(Safety and Efficacy Issues)
March 22, 2007... Australia -- The Therapeutic Goods Administration (TGA) has released a statement about the safety of Ayurvedic medicines in Australia, in response to recent research into the toxic content of heavy metals found in some Ayurvedic medicines (1)....

ADHD drugs: cardiovascular and psychiatric events.(Safety and Efficacy Issues)
March 22, 2007... United States of America -- The Food and Drug Administration (FDA) has directed the manufacturers of all drug products approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) to develop Patient Medication Guides concerning...

Clozapine can impair motility of the entire GI tract.(Safety and Efficacy Issues)
March 22, 2007... New Zealand -- Clozapine (Clozaril[R], Clopine[R]) is an atypical antipsychotic that is effective for treatment-resistant schizophrenia. It causes agranulocytosis in up to 1% of patients (1) and regular monitoring of neutrophil counts is...

15th Model List of Essential Medicines.(Essential Medicines)
March 22, 2007... Model List updated The WHO Model List of Essential Medicines allows countries to select medicines of public health priority, address problems of cost and availability and provides guidance to pharmaceutical manufacturers on medicine needs....

WHO model list of essential medicines 15th edition, revised March 2007.(Essential Medicines)
March 22, 2007... Explanatory Notes The core list presents a list of minimum medicine needs for a basic health care system, listing the most efficacious, safe and cost-effective medicines for priority conditions. Priority conditions are selected on the...

Tegaserod: marketing suspension.(Regulatory Action and News)
March 22, 2007... Canada -- Marketing and sales of tegaserod hydrogen maleate (Zelnorm[R]) tablets have been suspended in Canada to permit further evaluation of important safety information. Zelnorm[R] is a serotonin 5-HT4 receptor partial agonist indicated...

Pergolide: voluntary withdrawal of products.(Regulatory Action and News)
March 22, 2007... United States of America--The Food and Drug Administration (FDA) has announced that manufacturers of pergolide drug products, used to treat Parkinson disease, will voluntarily remove these drugs from the market because of the risk of serious...

Aliskiren approved for hypertension.(Regulatory Action and News)
March 22, 2007... United States of America -- The Food and Drug Administration (FDA) has announced the approval of aliskiren (Tekturna[R]) tablets for the treatment of hypertension. Aliskiren acts by inhibiting renin. Effectiveness was demonstrated in six...

Lapatinib approved for advanced breast cancer.(Regulatory Action and News)
March 22, 2007... United States of America -- The Food and Drug Administration (FDA) has approved lapatinib (Tykerb[R]), a targeted anti-cancer treatment to be used in combination with capectabine (Xeloda[R]) for patients with advanced, metastatic breast cancer...

Adalimumab approved for Crohn disease.(Regulatory Action and News)
March 22, 2007... United States of America -- The Food and Drug Administration (FDA) has approved adalimumab (Humira[R]) to treat adult patients with moderate to severe Crohn disease. Adalimumab is a human-derived, genetically-engineered monoclonal antibody to...

Rapid test for meningitis cleared for marketing.(Regulatory Action and News)
March 22, 2007... United States of America -- The Food and Drug Administration (FDA) has cleared for marketing a test that uses molecular biology to quickly detect the preserice of viral meningitis. The Xpert EV[R] test, when used in combination with other...

Eculizumab approved for paroxysmal nocturnal haemoglobinuria.(Regulatory Action and News)
March 22, 2007... United States of America -- The Food and Drug Administration (FDA) has approved eculizumab (Solids[R]), the first product for the treatment of paroxysmal nocturnal haemoglobinuria (PNH), a rare type of blood disorder that can lead to disability...

Neglected tropical diseases.(Access to Medicines)(Brief article)
March 22, 2007... One sixth of the world's population suffer from one or more neglected tropical diseases such as Buruli ulcer, cholera, cysticercosis, dracunculiasis (guineaworm disease), foodbome trematode infections, such as fascioliasis, hydatidosis,...

Open access database for neglected medicines development.(Access to Medicines)
March 22, 2007... An international network of researchers has announced the release of a new web-based resource designed to facilitate the development of medicines to fight infectious diseases afflicting the developing world. The Drug Target Prioritization...

Artemether and lumefantrine capsules.(International Pharmacopoeia)(Drug overview)
March 22, 2007... Draft proposal for the International Pharmacopoeia (March 2007). Please address any comments to Quality Assurance and Safety: Medicines, Medicines Policy and Standards, World Health Organization, 1211 Geneva 27, Switzerland Fax: ++41 22 791...

Magnesium sulfate injection/Magnesi sulfatis injectio.(International Pharmacopoeia)
March 22, 2007... Draft proposal for the International Pharmacopoeia (March 2007). Please address any comments to Quality Assurance and Safety: Medicines, Medicines Policy and Standards, World Health Organization, 1211 Geneva 27, Switzerland. Fax: ++41 22 791...

Zinc sulfate/Zinci sulfas.(International Pharmacopoeia)
March 22, 2007... Zinc sulfate monohydrate Zinc sulfate heptahydrate Draft proposal for the International Pharmacopoeia (March 2007). Please address any comments to Quality Assurance and Safety: Medicines, Medicines Policy and Standards, World Health...

Paediatric zinc sulfate tablets.(International Pharmacopoeia)
March 22, 2007... Draft proposal for the International Pharmacopoeia (March 2007). Please address any comments to Quality Assurance and Safety: Medicines, Medicines Policy and Standards, World Health Organization, 1211 Geneva 27, Switzerland. Fax: ++4122 791...

Paediatric zinc sulfate oral solution.(International Pharmacopoeia)
March 22, 2007... Draft proposal for the International Pharmacopoeia (March 2007). Please address any comments to Quality Assurance and Safety." Medicines, Medicines Policy and Standards, World Health Organization, 1211 Geneva 27, Switzerland Fax: ++41 22 791...

Informed consent for research in resource-poor settings.(Recent Publications, Information and Events)
March 22, 2007... Ethical challenges in study design and informed consent for health research in resource-poor settings considers ethical challenges to research design and informed consent in biomedical and behavioural studies conducted in resource-poor...

Lessons learned in home management of malaria: Implementation research in four African countries.(Recent Publications, Information and Events)
March 22, 2007... Studies on treatment-seeking behaviour have shown that most malaria episodes are first treated at home using shop-bought drugs. Part of the reason for this is poor access to formal health services. These treatments may be incorrect or...

Developing drug information centres in India.(Recent Publications, Information and Events)
March 22, 2007... A unique training workshop was organized in Bangalore in December 2006. Participants from India were provided with an introduction to drug information practice and rational drug use. The course was a part of a programme to expand the influence...

First-in-man clinical trials for high risk products.(Recent Publications, Information and Events)
March 22, 2007... European Union -- The Committee for Medicinal Products for Human Use (CHMP) has adapted a draft guideline for first-in-man clinical trials for potential high-risk medicinal products. This guideline has been prepared as one of the measures for...

Pakistan Pharmacists Society discussion forum.(Recent Publications, Information and Events)
March 22, 2007... The Pakistan Pharmacists Society promotes and expands the profession of pharmacy and the role of pharmacists. In order to improve drug use and pharmacy practice in the country, the Society has launched a website to serve as an online source of...

New quality assurance compendium.(Recent Publications, Information and Events)
March 22, 2007... Over the years, WHO's Expert Committee on Specifications for Pharmaceutical Preparations has made numerous recommendations to establish standards and guidelines and to promote the effective functioning of national regulatory and control systems...

Pharmacological management of human H5N1 infection.(Recent Publications, Information and Events)(Disease/Disorder overview)
March 22, 2007... The recent geographical spread of highly pathogenic avian influenza A virus in poultry and wild waterfowl has increased opportunities for transmission of the H5N1 virus to humans. Outbreaks in poultry have now been accompanied by human cases in...

International Nonproprietary Names for Pharmaceutical Substances (INN).
March 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.(Table)
March 22, 2007... Proposed International Non Proprietary Names (Prop. INN): List 31 (WHO Chronicle, Vol. 28, No. 3, 1974) p. 22 dimemorfanum dimemorfan replace graphic formula by the ...