WHO Drug Information articles from March 2003

WHO Drug Information archives from March 2003

Implementation of good manufacturing practices.(Good Manufacturing Practices)
March 22, 2003... Implementation of good manufacturing practices Medicines are important tools in improving and maintaining health. Whilst standards for ensuring the quality of medicines at international level are becoming increasingly rigorous, quality...

Pharmacogenetics and existing therapies.(Personal Perspectives)
March 22, 2003... Pharmacogenetics and existing therapies There is increasing evidence that pharmacogenetics will soon be playing a vital role in public health. Understanding genetic factors that determine the response to drugs, together with increased...

Fluticasone and adrenal crisis.(Safety Issues)
March 22, 2003... There have recently been several reports worldwide of adrenal insufficiency developing in children using inhaled corticosteroids. The Australian Adverse Reactions Advisory Committee (ADRAC) has received 10 such reports from Australia. Eight...

Thiazolidinediones experience.(Safety Issues)
March 22, 2003... Pioglitazone (Actos[R]) and rosiglitazone (Avandia[R]) are thiazolidinediones, a new class of oral antidiabetic drugs, which act on the peroxisome proliferator activated gamma (PPARg) nuclear receptor to reduce tissue insulin resistance....

Cefepime, ceftazidime and neurotoxicity.(Safety Issues)
March 22, 2003... A recent study appearing in Pharmacotherapy has reviewed 42 cases of cefepime-induced neurotoxicity and 12 cases of ceftazidime-induced neurotoxicity. Both the frequency of drug resistance and the prescription of broad-spectrum antibiotics...

Interstitial nephritis and proton pump inhibitors.(Safety Issues)
March 22, 2003... Interstitial nephritis is a well-recognized but rare hypersensitivity reaction to omeprazole (1). Patients present with non-specific symptoms of illness. The classic triad for interstitial nephritis of fever, rash and eosinophilia is uncommon...

Interactions with grapefruit juice.(Safety Issues)
March 22, 2003... Following comments received after publication of its recent article (1), the Australian Adverse Drug Reactions Advisory Committee (ADRAC) has re-evaluated the literature, and wishes to revise its advice. Although there are no case reports of...

New network for guideline development.(Current Topics)
March 22, 2003... The World Health Organization has become a founding member of the new Guidelines International Network (GIN). This is a major new international collaboration involving organizations from around the world. GIN seeks to improve the quality of...

Fake artesunate tablets circulating again.(Current Topics)
March 22, 2003... In the late 1990s, counterfeits of artesunate, a vital life-saving antimalarial drug, were discovered circulating in South-east Asia (1). Up to 38% of 'artesunate' labelled as manufactured by Guilin Pharma, People's Republic of China, bought...

European Union enlargement: observers to EMEA.(Current Topics)
March 22, 2003... The ten accession candidate countries expected to join the European Union in May 2004--Cyprus, Czeck Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, The Slovak Republic and Slovenia--began work with the European Agency for the...

Clinical cancer research review.(Current Topics)
March 22, 2003... The American Society of Clinical Oncology (ASCO) has released new recommendations to improve the cancer clinical trial review system. The new policy is unique in its recommendation that oversight and review of cancer clinical trials be...

New foundation will develop tests for infectious diseases.(Current Topics)
March 22, 2003... In response to a critical need for new tools to detect infectious diseases, the UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) and the Bill & Melinda Gates Foundation have announced a new initiative...

TDR research training in 2004.(Current Topics)
March 22, 2003... The UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) invites applications for the award of research training grants from individuals who are nationals of and employed in developing disease-endemic...

Managing drug supply for primary health care.(Current Topics)
March 22, 2003... WHO, in association with the International Dispensary Association (IDA), Management Sciences for Health (MSH), and Reseau Medicaments et Developpement (ReMeD), has organized a training course for pharmacists, physicians, senior health system...

Latin American pharmacotherapy course.(Current Topics)
March 22, 2003... The Fifth Latin American Course on Pharmacotherapy will be held from 31 August-12 September 2003, in La Plata, Argentina. It is being organized by the Universidad Nacional de La Plata (Argentina) in collaboration with the World Health...

Gefitinib approved for lung cancer.(Regulatory and Safety Action)
March 22, 2003... United States of America -- The Food and Drug Administration (FDA) has announced the approval of gefitinib (Iressa[R]) tablets as a single agent treatment for patients with advanced non small-cell lung cancer (NSCLC), the most common form of...

New breath test for monitoring asthma.(Regulatory and Safety Action)
March 22, 2003... United States of America -- The Food and Drug Administration (FDA) has cleared for marketing a first-of-a-kind, non-invasive test system to measure the concentration of nitric oxide in exhaled human breath. The test system should make it...

Risperidone: prescribing information update.(Regulatory and Safety Action)
March 22, 2003... United States of America -- The manufacturer of the antipsychotic, risperidone (Risperdal[R]), has updated the prescribing information to include a warning of cerebrovascular adverse events, including stroke, in elderly patients with...

Pan Pharmaceuticals product recalls.(Regulatory and Safety Action)
March 22, 2003... Australia -- The Therapeutic Goods Administration (TGA), has suspended the licence held by Pan Pharmaceuticals Limited, Sydney, to manufacture medicines following a series of serious safety and quality breaches by the company. These included...

Telithromycine and myasthenia gravis.(Regulatory and Safety Action)
March 22, 2003... Spain -- The Spanish Medicines Agency, in line with other Agencies of the European Union, has announced the urgent modification to the data sheet information concerning administration of telithromycine (Ketek[R]) in myasthenia gravis...

Astemizole: marketing suspension.(Regulatory and Safety Action)
March 22, 2003... Spain -- The Spanish Medicines Agency has decided to suspend the marketing authorization for the non-sedating antihistamine, astemizole. Use has been associated with a risk of cardiac arrhythmia which has been demonstrated in a review of...

Somatropin: negative opinion.(Regulatory and Safety Action)
March 22, 2003... European Union -- The Committee for Proprietary Medicinal Products of the European Agency for the Evaluation of Medicinal Products (EMEA) has adopted a negative opinion on the request for marketing authorization for somatropin (Serostim[R])...

Repaglinide and gemfibrozil: hazardous interaction.(Regulatory and Safety Action)
March 22, 2003... European Union -- The European Agency for the Evaluation of Medicinal Products (EMEA) has issued a public statement concerning an interaction between repaglinide (NovoNorm[R] and Prandin[R]), a medicine used to lower blood sugar in diabetic...

Adhesion prevention solution global withdrawal.(Regulatory and Safety Action)
March 22, 2003... United States of America -- The Food and Drug Administration (FDA) has received notification of a voluntary withdrawal of Gynecare Intergel Adhesion Prevention Solution[R] from the market. The manufacturer is urging customers to immediately...

Counterfeit Lipitor[R].(Regulatory and Safety Action)
March 22, 2003... United States of America -- The Food and Drug Administration (FDA) has announced that three lots of 90-count bottles of the cholesterol-lowering drug Lipitor[R] have been voluntarily recalled and is warning of a potentially significant risk...

Paroxetine: avoid in children and adolescents.(Regulatory and Safety Action)
March 22, 2003... United Kingdom --The Chairman of the Committee on Safety of Medicines (CSM) has informed prescribers of new evidence relating to the efficacy and safety of the selective serotonin re-uptake inhibitors (SSRI), paroxetine (Seroxat[R])in...

Aprepitant for nausea and vomiting during chemotherapy.(Regulatory and Safety Action)
March 22, 2003... United States of America -- The Food and Drug Administration (FDA) has announced the approval of a new drug called aprepitant (Emend[R]), to be used in combination with other anti-nausea and anti-vomiting drugs for prevention of acute and...

Agalsidase beta approved.(Regulatory and Safety Action)
March 22, 2003... United States of America -- The Food and Drug Administration (FDA) has approved the first treatment for patients with Fabry Disease, a serious metabolic genetic disorder affecting approximately one in 40 000 males. While it is believed that...

Imatinib mesylate approved for paediatric leukaemia.(Regulatory and Safety Action)
March 22, 2003... United States of America -- The Food and Drug Administration (FDA) has announced the approval of imatinib mesylate (Gleevec [R]) tablets for the treatment of paediatric patients with Philadelphia chromosome positive (Ph+) chronic myeloid...

Drug-eluting stent for clogged heart arteries.(Regulatory and Safety Action)
March 22, 2003... United States of America -- The Food and Drug Administration (FDA) has approved the first drugeluting stent for angioplasty procedures to open clogged coronary arteries. In most cases, a stent is left permanently in the artery to keep the...

Pegvisomant for acromegaly.(Regulatory and Safety Action)
March 22, 2003... United States of America -- The Food and Drug Administration (FDA) has approved pegvisomant (Somaver[R]) for the treatment of acromegaly, a potentially life threatening disease triggered by an excess of growth hormone. Pegvisomant, the first...

Fixed-combination medicines: an Australian perspective.(Aspects of Quality Assurance)
March 22, 2003... In Australia, the Therapeutic Goods Act 1989 provides for a national system of controls for the regulation of therapeutic goods, including both medical products and medical devices. The Therapeutic Goods Act 1989 is administered by the...

International Travel & Health.(Recent Publications and Sources of Information)
March 22, 2003... The latest edition of International Travel and Health has been completely redesigned to reflect better knowledge about the risks to which travellers are exposed and the precautions needed to protect their health. With new material and a...

Affordability of medicines.(Recent Publications and Sources of Information)
March 22, 2003... In developing countries, most medicines are paid for out-of-pocket by individual patients rather than through social security systems. High prices are therefore a barrier to use of medicines and health products. Too little is known about the...

Drugs and money.(Recent Publications and Sources of Information)
March 22, 2003... Society attaches great importance to better health, and has witnessed a rising demand for health care. The rapid growth of expenditure on medicines is of particular concern and it has attracted considerable political attention, partly because...

ABPI launches online clinical trials register.(Recent Publications and Sources of Information)
March 22, 2003... An online register of industry-sponsored clinical trials has been launched by the Association of the British Pharmaceutical Industry (ABPI). So far, the register includes details of 65 trials sponsored by five companies. Since 2001, the...

Expert Committee on Drug Dependence Report.(Recent Publications and Sources of Information)
March 22, 2003... The Thirty-third report presents recommendations from the Expert Committee on Drug Dependence which is responsible for reviewing information on dependence-producing drugs and assessing the need for international control by the UN Commission...

Biomedical research in human subjects.(Recent Publications and Sources of Information)
March 22, 2003... The Council for International Organizations of Medical Sciences (CIOMS) has published the revised International Ethical Guidelines for Biomedical Research Involving Human Subjects. This is the third revision of the guidelines, first issued in...

International Nonproprietary Names for Pharmaceutical Substances (INN).
March 22, 2003... RECOMMENDED International Nonproprietary Names (Rec. INN): List 49 Notice is hereby given that, in accordance with paragraph 7 of the Procedure for the Selection of Recommended International Nonproprietary Names for Pharmaceutical...