WHO Drug Information articles from March 2005

WHO Drug Information archives from March 2005

International nomenclature and gene therapy products.(Biomedicines Update)
March 22, 2005... The International Nonproprietary Names (INN) Programme is a core activity embedded in the normative functions of the World Health Organization (WHO) and has served the global public health and medicines community for over fifty years. The...

Current INN policy on biological products.(Biomedicines Update)
March 22, 2005... The WHO INN Programme was established to assign nonproprietary names to medicinal substances so that each substance would be recognized globally by a unique name. Such names are needed because chemical descriptions are usually very complex...

Monitoring Group on Gene Transfer Medicinal Products.(Biomedicines Update)
March 22, 2005... In parallel to these activities, a WHO Monitoring Group on Gene Transfer Medicinal Products has been established and two meetings have taken place (2-3) to review the situation concerning gene therapy. After reviewing the current situation on...

The need for nomenclature of gene therapy products.(Biomedicines Update)
March 22, 2005... On 27 January 2005, an informal consultation was held at WHO to discuss the elements of an INN policy on nomenclature for gene therapy products. Participants reviewed the current range of gene transfer products which could be included in a...

Regulatory policy and nomenclature: country reports.(Biomedicines Update)
March 22, 2005... In Japan, no consideration has yet been given to developing a policy on systematic names for gene transfer products. The emphasis has been on providing detailed guidance on quality and safety issues, including those issues related to the...

Tiagabine: seizures in patients without a history of epilepsy.(Safety and Efficacy Issues)
March 22, 2005... United States of America -- The manufacturer of tiagabine hydrochlorine (Gabitril[R]) has informed prescribers of important new safety information regarding the risk of new onset seizures and status epilepticus in patients without a history...

Effect of medroxyprogesterone on bone mineral density.(Safety and Efficacy Issues)
March 22, 2005... Singapore -- New data suggest that women who use medroxyprogesterone acetate for long-term contraception may lose significant bone mineral density (BMD). Medroxyprogesterone acetate (Depo-Provera[R]) is a progestogen-only injection. It was...

Tumour necrosis factor inhibitors: safety update.(Safety and Efficacy Issues)
March 22, 2005... Singapore -- Three tumour necrosis factor (TNF) blocking agents are registered in Singapore and are licensed for the treatment of rheumatoid arthritis: infliximab (Remicade[R]), etanercept (Enbrel[R]) and adalimumab (Humira[R]). These...

Pimecrolimus and tacrolimus linked to cancer increase.(Safety and Efficacy Issues)
March 22, 2005... United States of America -- The Food and Drug Administration (FDA) has advised health care professionals to prescribe pimecrolimus (Elidel[R]) and tacrolimus (Protopic[R]) only as directed and only after other eczema treatments have failed to...

Erythropoietin: caution in cancer patients.(Safety and Efficacy Issues)
March 22, 2005... Singapore -- There are two erythropoietins (EPO) currently registered in Singapore: epoetin alfa (Eprex[R]) and epoetin beta (Recormon[R]). Both products are indicated for: * treatment of anaemia in patients associated with renal failure;...

Oxcarbazepine: multi-organ hypersensitivity.(Safety and Efficacy Issues)
March 22, 2005... Canada -- The manufacturer of oxcarbazepine (Trileptal[R]) has communicated new safety information concerning the risk of serious dermatological reactions, including Stevens Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN), as well...

Drotrecogin alfa: single organ dysfunction.(Safety and Efficacy Issues)
March 22, 2005... United States of America -- The manufacturer of drotrecogin alfa (activated) (Xigris[R]) has communicated new safety information on drotrecogin alfa, a biological therapeutic product indicated for the treatment of adult patients with severe...

Drotrecogin alfa: not indicated for paediatric sepsis.(Safety and Efficacy Issues)
March 22, 2005... Canada -- The manufacturer of drotrecogin alfa (Xigris[R]), recombinant human activated protein C, rhAPC, has informed healthcare professionals of important safety information. Drotrecogin alfa is indicated for the treatment of adult patients...

Interferon beta-1a and hepatic injury.(Safety and Efficacy Issues)
March 22, 2005... United States of America -- Interferon beta-1a (Avonex[R]) was introduced to the United States market in 1996. In post-marketing experience severe hepatic injury, including hepatic failure, has been reported rarely. In some cases, these...

Avascular necrosis with interferon alfa-2b in chronic myelogenous leukaemia.(Safety and Efficacy Issues)
March 22, 2005... Australia -- Out of a total of 426 reports involving interferon alfa-2b (Intron A[R]), the Adverse Drug Reaction Advisory Committee (ADRAC) has received six reports of avascular necrosis, aseptic necrosis or osteonecrosis in association with...

Hylan G-F 20: joint inflammation and pain.(Safety and Efficacy Issues)
March 22, 2005... Canada -- Hylan G-F 20 (Synvisc[R]) is an elastoviscous fluid containing hylan polymers, which are derivatives of hyaluronan (sodium hyaluronate). It is indicated for the treatment of pain caused by osteoarthritis of the knee in patients who...

Galantamine and vascular events.(Safety and Efficacy Issues)
March 22, 2005... United States of America -- The prescribing information for galantamine hydrobromide (Reminyl[R]) has been updated to reflect the results of two investigational studies in individuals with mild cognitive impairment. Galantamine is approved...

Rosuvastatin: revised start doses.(Safety and Efficacy Issues)
March 22, 2005... United states of America -- A revised package insert has been published by the manufacturer of rosuvastatin (Crestor[R]). Changes to the label reflect results from a Phase IV pharmacokinetic study in Asian-Americans and highlight important...

New kidney function test a better predictor of risk.(Safety and Efficacy Issues)
March 22, 2005... United States of America -- Cystatin-C[R], a new blood test for kidney function, is a better predictor of death and cardiovascular risk among the elderly than the standard measure of kidney function, according to a National Heart, Lung, and...

Statins and peripheral neuropathy.(Safety and Efficacy Issues)
March 22, 2005... Australia -- The Adverse Drug Reactions Advisory Committee (ADRAC) has received 281 reports of peripheral neuropathy or symptoms consistent with this diagnosis attributed to statins (see Table below), and first highlighted this association in...

Angioedema: still a problem with ACE inhibitors.(Safety and Efficacy Issues)
March 22, 2005... Australia -- Of over 7000 reports of angioedema received by the Adverse Drug Reactions Advisory Committee (ADRAC) since 1970, ACE inhibitors account for 12.6%. Angioedema may present with acute onset of soft-tissue swelling of part or all of...

More advice on SSRI use.(Safety and Efficacy Issues)
March 22, 2005... United Kingdom -- The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a reminder on selective serotonin reuptake inhibitor use (SSRIs). This reminder is prompted by a number of studies on SSRIs published in the British...

Million women study: latest HRT data.(Safety and Efficacy Issues)
March 22, 2005... United Kingdom -- The Committee on the Safety of Medicines (CSM) has commented on data from the UK Million Women Study. This adds important information to growing knowledge of the effects of different types of hormone replacement therapy...

Tuberculin purified protein derivative (Mantoux) and serious allergic reactions.(Safety and Efficacy Issues)
March 22, 2005... Canada -- Acute allergic reactions including anaphylaxis, angioedema, urticaria and/or dyspnoea have been very rarely reported following intradermal skin testing with tuberculin purified protein derivative (Tubersol[R]). These reactions...

Ezetimibe: hepatic, muscle, and pancreatic reactions.(Safety and Efficacy Issues)
March 22, 2005... Canada -- Health Canada and the manufacturer of ezetimibe (Ezetrol[R]), have provided new safety data on this cholesterol absorption inhibitor, used alone or in combination with a statin, because of the entero-hepatic recirculation of one of...

Mefloquine: revised patient information.(Safety and Efficacy Issues)
March 22, 2005... Canada -- Health Canada has advised of the availability of revised patient information for prophylactic use of the antimalarial, mefloquine (Apo-Mefloquine[R]). The warnings and contraindications sections have been modified to inform of:...

Atomoxatine and liver injury.(Safety and Efficacy Issues)
March 22, 2005... United States of America -- The US Food and Drug Administration (FDA) is advising health care professionals of a new warning for atomoxatine (Strattera[R]), a drug approved for attention deficit hyperactivity disorder (ADHD) in adults and...

Gefitinib: failure to show survival in lung cancer.(Safety and Efficacy Issues)
March 22, 2005... United States of America -- The Food and Drug Administration (FDA) has reported that a large clinical trial comparing gefitinib (Iressa[R]) with placebo in patients with non-small cell lung cancer who had failed other courses of cancer...

Progress on defining borderline pharmaceutical products.(Regulatory Action and News)
March 22, 2005... European Union -- Article 2.2 of Directive 2001/ 83/EC on the Community code relating to medicinal products for human use aims to address the issue of the borderline products. The new legislation is applicable from 30 October 2005 through...

Temozolomide approved for glioblastoma multiforme.(Regulatory Action and News)
March 22, 2005... United States of America -- The Food and Drug Administration (FDA) has granted approval of a new indication for temozolomide (Temodar[R]). The drug, used concurrently with radiotherapy and as maintenance therapy after radiotherapy, can extend...

Pramlintide approved for diabetes.(Regulatory Action and News)
March 22, 2005... United States of America -- The Food and Drug Administration (FDA) has approved an injectable medicine, pramlintide acetate (Symlin[R]), to control blood sugar for adults with type 1 and type 2 diabetes. Pramlintide, a synthetic analogue of...

Entecavir approved for chronic hepatitis B.(Regulatory Action and News)
March 22, 2005... United States of America -- The Food and Drug Administration (FDA) has announced the approval of entecavir (Baraclude[R]) tablets and oral solution for the treatment of chronic hepatitis B in adults. Chronic hepatitis B is a serious...

DNA-based test approved to detect cystic fibrosis.(Regulatory Action and News)
March 22, 2005... United States of America -- The Food and Drug Administration (FDA) has approved the first DNA-based blood test to help detect cystic fibrosis. The Tag-It Cystic Fibrosis Kit[R] directly analyses human DNA to find genetic variations indicative...

Nataluzimab: marketing withdrawal pending evaluation.(Regulatory Action and News)
March 22, 2005... United States of America -- The Food and Drug Administration (FDA) has issued a public health advisory to inform patients and health care providers about the suspended marketing of nataluzimab (Tysabri[R]) while two serious adverse events are...

Rosiglitazone (Nyracta[R]): voluntary withdrawal.(Regulatory Action and News)
March 22, 2005... European Union -- On 11 July 2000 the European Commission granted a marketing authorization for the whole European Union to the manufacturers of rosiglitazone (Rosiglitazone is indicated as oral monotherapy in type 2 diabetes mellitus...

Risk management legislation.(Regulatory Action and News)
March 22, 2005... European Union -- As a result of a collaboration between the Heads of the National Medicines Agencies across the EU and the European Medicines Agency (EMEA), two key documents on the European Risk Management Strategy have been published. They...

New pharmacogenomics guidance.(Regulatory Action and News)
March 22, 2005... United States of America -- As part of an initiative to speed development of new medical products through the science of pharmacogenomics, the Food and Drug Administration (FDA) has issued a guidance document, Pharmacogenomic Data...

WHO clinical trial registration initiative.(Current Topics)
March 22, 2005... Access to information about ongoing, completed or published clinical research is essential for appropriate decision-making. Researchers, research funders, policy-makers, medical practitioners, patients and the general public need such...

International registration of trial information: Ottawa statement.(Current Topics)
March 22, 2005... Registration of trials is essential to ensure all results are publicly available and that ethical obligations to participants are met. Recent evidence of selective reporting of results has eroded public and academic confidence in publications...

Disclosure of information on clinical trials.(Current Topics)
March 22, 2005... The research-based pharmaceutical industry has announced principles of disclosure of clinical trial information through clinical trial registries and databases. The International Federation of Pharmaceutical Manufacturers and Associations...

Forecasting antiretroviral and diagnostic needs.(Current Topics)
March 22, 2005... Over the last four years, access to antiretrovirals (ARVs) and diagnostics for people living with HIV/ AIDS (PLWHA) has become easier owing to the availability of more affordable generic products of assured quality supported by public...

ATC/DDD classification (temporary).(anatomical therapeutic chemical classifications/ defined daily doses)
March 22, 2005... 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 April 2005. Comments or objections to the decisions...

ATC/DDD classification (final).(anatomical therapeutic chemical classifications/defined daily doses)
March 22, 2005... 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 2004. They came into force on 1 March 2005 and...

Sources and prices of malaria medicines and products.(Recent Publications and Sources of Information)
March 22, 2005... WHO has released a report entitled Sources and Prices of Selected Products for the Prevent/on, Diagnosis and Treatment of Malaria which provides market information on products reviewed for the prevention, diagnosis and treatment of malaria...

Launch of a searchable online database of adverse reactions.(Recent Publications and Sources of Information)
March 22, 2005... Health Canada has announced the launch of a searchable online database that will, for the first time, allow immediate, direct access to the latest reported adverse reactions to health products as recorded in Health Canada's Canadian Adverse...

Recently published European Union guidelines.(Recent Publications and Sources of Information)
March 22, 2005... Common Technical Document (CTD) format: adopted guidelines CHMP/EWP/252/03 Guideline on clinical investigation of medicinal products intended for the treatment of neuropathic pain. Effective: 1 June 2005 CPMP/BWP/5180/03 ...

Lamivudinum Lamivudine (first draft).(Monographs for antiretrovirals)
March 22, 2005... [C.sub.8][H.sub.11][N.sub.3][O.sub.3]S Relative molecular mass. 229.3 Chemical name. (-)4-amino-1-[(2R,5S)-2-(hydroxymethyl) -1,3-oxathiolan-5-yl]pyrimidin-2(1H)-one; CAS Reg. NO. 134678-17-4. Description. A white or almost white...

Nelfinavir mesilas pulvis oralis (first draft) Nelfinavir mesilate oral powder.(Monographs for antiretrovirals)
March 22, 2005... Category. Antiretroviral (protease inhibitor). Storage. Nelfinavir mesilate oral powder should be kept in a tightly closed container, protected from light. Labelling. The designation on the container of nelfinavir mesilate oral...

Nelfinavir mesilas compressi Nelfinavir mesilate tablets (first draft).(Monographs for antiretrovirals)
March 22, 2005... Category. Antiretroviral (protease inhibitor). Storage. Nelfinavir mesilate capsules should be kept in a tightly closed container, protected from light. Labelling. The designation on the container of nelfinavir mesilate tables should...

Saquinavirum mesilas capsulae Saquinavir mesilate capsules (first draft).(Monographs for antiretrovirals)
March 22, 2005... Category. Antiretroviral (protease inhibitor). Storage. Saquinavir mesilate capsules should be kept in a well-closed container, protected from light. Labelling. The designation on the container of saquinavir mesilate capsules should...

Stavudinum Stavudine (first draft).(Monographs for antiretrovirals)
March 22, 2005... [C.sub.10][H.sub.12][N.sub.2][O.sub.4] Relative molecular mass. 224.2 Chemical name. 1-[(2R,5,S)-5-(hydroxymethyl)-2,5-dihydrofuran-2-yl] -5-methylpyrimidine-2,4(1H,3H)-dione; 1-(2,3-dideoxy-[beta]...

Zidovudinum Zidovudine (first draft).(Monographs for antiretrovirals)
March 22, 2005... [C.sub.10][H.sub.13][N.sub.5][O.sub.4] Relative molecular mass. 267.2 Chemical name. 1-[(2R,4S,5S)-4-azido-5-(hydroxymethyl) tetrahydrofuran-2-yl]-5-methyl-pyrimidine2,4(1H,3H)-dione;...

International nonproprietary names for pharmaceutical substances (INN).
March 22, 2005... 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.(Illustration)
March 22, 2005... Proposed International Non Proprietary Names (Prop. INN): List 35 Denominations communes internationales proposees (DCI Prop.): Liste 35 Denominaciones Comunes internacionales Propuestas (DCI Prop.): Lista 35 (WHO Drug Information, Vol....

Procedure for the selection of recommended international nonproprietary names for pharmaceutical substances *.(Annex 1)
March 22, 2005... The following procedure shall be followed by the World Health Organization in the selection of recommended international nonproprietary names for pharmaceutical substances, in accordance with the World Health Assembly resolution WHA3.11: ...

General principles for guidance in devising international nonproprietary names for pharmaceutical substances *.(Annex 2)
March 22, 2005... 1. International Nonproprietary Names (INN) should be distinctive in sound and spelling. They should not be inconveniently long and should not be liable to confusion with names in common use. 2. The INN for a substance belonging to a...

Procedure a suivre en vue du choix de denominations communes internationales recommandees pour les substances pharmaceutiques *.(Annexe 1)
March 22, 2005... L'Organisation mondiale de la Sante observe la procedure exposee ci-dessous pour l'attribution de denominations communes internationales recommandees pour les substances pharmaceutiques, conformement a la resolution WHA3.11 de l'Assemblee...

Directives generales pour la formation de denominations communes internationales applicables aux substances pharmaceutiques *.(Annexe 2)
March 22, 2005... 1. Les denominations communes internationales (DCI) devront se distinguer les unes des autres par leur consonance et leur orthographe. Elles ne devront pas etre d'une longueur excessive, ni preter a confusion avec des appellations deja...

Procedimiento de seleccion de denominaciones comunes internacionales recomendadas para las sustancias farmaceuticas *.(Anexo 1)
March 22, 2005... La Organizacion Mundial de la Salud seguira el procedimiento que se expone a continuacion para la seleccion de denominaciones comunes internacionales recomendadas para las sustancias farmaceuticas, de conformidad con lo dispuesto en la...

Principios generales de orientacion para formar denominaciones comunes internacionales para sustancias farmaceuticas *.(Anexo 2)
March 22, 2005... 1. Las Denominaciones Comunes Internacionales (DCI) deberan diferenciarse tanto fonetica como ortograficamente. No deberan ser incomodamente largas, ni dar lugar a confusion con denominaciones de uso comun. 2. La DCI de una sustancia que...