WHO Drug Information articles from January 2006

WHO Drug Information archives from January 2006

Combating counterfeit medicines.(Counterfeit Medicines)
January 1, 2006... Counterfeit medicines are part of a broader phenomenon of substandard pharmaceuticals. They are deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can involve both branded and generic products and...

Strengthening global cooperation through IMPACT.(Counterfeit Medicines)
January 1, 2006... Since 1992, the World Health Organization (WHO) has been calling for action against the growing epidemic of counterfeit medicines. In a bid to accelerate the war on fake drugs, WHO is pushing for stronger global cooperation, political...

WHO International Conference on combating counterfeit medicines.(Counterfeit Medicines)
January 1, 2006... DECLARATION OF ROME 1. Counterfeiting medicines, including the entire range of activities from manufacturing to providing them to patients, is a vile and serious criminal offence that puts human lives at risk and undermines the...

Supply of life-saving antisera: a growing need for concern.(Biological Medicines)
January 1, 2006... Antisera represent the only therapy for the treatment of envenomation and are essential, in combination with vaccination, for post-exposure rabies treatment. Antisera are produced by the fractionation of plasma obtained from horses immunized...

Latest developments in biological standardization.(Biological Medicines)
January 1, 2006... WHO's biological standardization programme provides, promotes and implements global norms and standards for biological medicines, and strives to provide the most relevant products for the improvement of global health. The WHO Expert...

Biological substances: international standards and reference reagents.(Biological Medicines)
January 1, 2006... Biological substances: International standards and reference reagents Preparation Activity Status Antigens and related substances Haemophilus influenza 4.933 [+ or -] 0.267 First International...

Suicidality risk associated with atomoxetine.(Safety and Efficacy Issues)
January 1, 2006... Singapore -- Atomoxetine (Strattera[R]) a norepinephrine re-uptake inhibitor, is licensed for the treatment of attention deficit hyperactivity disorder in children 6 years of age and older, in adolescents and adults. It was registered in...

Drug interaction between capecitabine and warfarin.(Safety and Efficacy Issues)
January 1, 2006... Singapore -- Capecitabine (Xeloda[R]) is a cytostatic agent indicated for metastatic breast cancer when used as an adjunct to docetaxel, and for metastatic colorectal cancer. The co-administration of capecitabine and warfarin may predispose a...

Fluoroquinolone antibiotics and interaction with warfarin.(Safety and Efficacy Issues)
January 1, 2006... Australia -- The potential interaction between warfarin and fluoroquinolones (ciprofloxacin, norfloxacin, moxifloxacin, gatifloxacin) was reported in a 1993 review (1). The Australian Adverse Drug Reactions Committee (ADRAC) has received 20...

Clozapine: revised monitoring frequency.(Safety and Efficacy Issues)
January 1, 2006... United States of America -- After reviewing recommendations provided by the Psychopharmacological Drugs Advisory Committee (PDAC) of June 2003 regarding the white blood cell monitoring schedule required for all clozapine users, the Food and...

Hepatitis B reactivation and anti-TNF[alpha] products.(Safety and Efficacy Issues)
January 1, 2006... Canada -- The manufacturers of anti-TNF[alpha] products, in consultation with Health Canada, have updated safety information regarding anti-TNF[alpha] therapy. There are three such products authorized for sale in Canada, and a summary of...

Clinical trials of gatifloxacin: shorter tuberculosis treatment regimen?(Safety and Efficacy Issues)
January 1, 2006... World Health Organization -- Clinical results on a new combination treatment that could dramatically shorten the length of tuberculosis (TB) treatment were recently presented at the 45th Annual Interscience Conference on Antimicrobial Agents...

Update on safety of oseltamivir.(Safety and Efficacy Issues)
January 1, 2006... European Union--A potential influenza pandemic remains currently of high public interest and the European Medicines Agency (EMEA) has provided the following update on oseltamivir (Tamiflu[R]). Oseltamivir is an antiviral approved in the...

Paroxetine: possible risk of teratogenicity.(Safety and Efficacy Issues)
January 1, 2006... Singapore -- The manufacturer of paroxetine has notified healthcare professionals of preliminary findings of a retrospective epidemiological study which showed a 2-fold increase in the risk of congenital malformations in infants born to...

Restrictions on use of promethazine in children.(Safety and Efficacy Issues)
January 1, 2006... Singapore -- The Health Sciences Authority (HSA) and its Pharmacovigilance Advisory Committee (PVAC) have recently reviewed the safety profile of promethazine in children following action taken by the US Food and Drug Administration (FDA) to...

Rosiglitazone and diabetic macular oedema.(Safety and Efficacy Issues)
January 1, 2006... United States of America -- The Food and Drug Administration (FDA) and the manufacturer of products containing rosiglitazone (Avandia[R], Avandamet[R], and Avandaryl[TM]) have received very rare postmarketing reports of new onset and...

Topical immunomodulators: carcinogenic potential?(Safety and Efficacy Issues)
January 1, 2006... Singapore -- Pimecrolimus cream (Elidel[R]) and tacrolimus ointment (Protopic[R]) are topical immunomodulators granted local marketing approval in January 2003 and March 2004 respectively. Elidel[R] (1%) is licensed for short-term and...

Telithromycin: serious liver toxicity.(Safety and Efficacy Issues)
January 1, 2006... United States of America -- An article reporting three patients who experienced serious liver toxicity following administration of telithromycin (Ketek[R]) has recently been published. The cases have also been reported to the Food and Drug...

Deaths with galantamine in mild cognitive impairment studies.(Safety and Efficacy Issues)
January 1, 2006... Australia -- Galantamine (Reminyl[R]), donepezil (Aricept[R]) and rivastigmine (Exelon[R]) are approved for the treatment of mild to moderately severe Alzheimer dementia. Cardiac arrhythmias with these cholinesterase inhibitors have been...

Fluoroquinolone antibiotics and tendon disorders.(Safety and Efficacy Issues)
January 1, 2006... Australia -- Since the beginning of 2005, the Australian Adverse Drug Reactions Committee (ADRAC) has received 16 cases of tendon disorders, predominantly Achilles tendinitis. Eleven of these cases have involved the fluoroquinolones...

Ergot derivatives and fibrotic reactions.(Safety and Efficacy Issues)
January 1, 2006... Australia -- Ergot derivatives are now the most commonly used dopamine agonists in the treatment of Parkinson disease in Australia. Important potential adverse reactions associated with ergot derivatives such as cabergoline, bromocriptine...

Immune globulin: possible intravascular haemolysis.(Safety and Efficacy Issues)(Brief article)
January 1, 2006... United States of America -- The Food and Drug Administration (FDA) has requested the manufacturer of an immune globulin product (WinRho[R] SDF) to address two safety concerns and alert patients to the early signs and symptoms of intravascular...

Aprotinin injection: renal toxicity and ischaemic events.(Safety and Efficacy Issues)
January 1, 2006... United States of America -- Recently published articles (1, 2) have associated aprotinin injection with serious renal toxicity and ischaemic events (myocardial infarction and stroke) in patients undergoing coronary artery bypass grafting...

Benzocaine sprays and methaemoglobinaemia.(Safety and Efficacy Issues)
January 1, 2006... United States of America -- Benzocaine sprays are used in medical practice for locally numbing mucous membranes of the mouth and throat for minor surgical procedures or when a tube must be inserted into the stomach or airways. Their use is...

Quetiapine and urinary disorders.(Safety and Efficacy Issues)
January 1, 2006... Netherlands -- Four reports of urinary retention and three reports of urinary incontinence associated with the use of quetiapine were received by the Pharmacovigilance Centre, Lareb, prior to mid June 2005. The time to urinary incontinence...

Hydroxyurea and risk of cutaneous vasculitic toxicities.(Safety and Efficacy Issues)
January 1, 2006... Canada -- Postmarketing case reports of cutaneous vasculitic toxicities, including vasculitic ulcerations and gangrene, have been received concerning patients with myeloproliferative disorders during therapy with hydroxyurea (Hydrea[R]). In...

Proton pump inhibitors and reduced testosterone levels.(Safety and Efficacy Issues)
January 1, 2006... Netherlands -- Prior to 30 June 2005, the Pharmacovigilance Centre, Lareb, received 28 reports of gynaecomastia associated with the use of proton pump inhibitors (PPIs), including omeprazole, lansoprazole, pantoprazole, esomeprazole and...

Colchicine and toxicity.(Safety and Efficacy Issues)
January 1, 2006... New Zealand -- The Medicines and Medical Devices Safety Authority, Medsafe, has revised the dosage advice for colchicine following reports of dose-related serious adverse effects. This advice coincides with the introduction of a colchicine...

Topical corticosteroids and skin damage.(Safety and Efficacy Issues)(Brief article)
January 1, 2006... New Zealand -- The Centre for Adverse Reactions Monitoring has received 14 reports of facial skin damage associated with the use of potent topical corticosteroids. The reports included telangiectasia, abnormal pigmentation, rosacea, perioral...

Pegaptanib sodium injection and hypersensitivity reactions.(Safety and Efficacy Issues)
January 1, 2006... Canada -- Health Canada has issued safety information for pegaptanib sodium injection (Macugen[R]), following postmarketing reports of hypersensitivity reactions including anaphylaxis/ anaphylactoid reactions. Ophthalmologists should be aware...

European Union initiative to evaluate medicines for developing countries.(Access to Medicines)
January 1, 2006... The European Medicines Agency (EMEA) is a decentralized body of the European Union located in London, United Kingdom. Its main responsibility is the protection and promotion of public and animal health through the evaluation and supervision...

Production and export of generic medicines under the TRIPS Agreement.(Access to Medicines)
January 1, 2006... At the WTO Ministerial Conference in Doha, November 2001, WTO Members adopted the Ministerial Declaration on the TRIPS Agreement and Public Health (the Doha Declaration). The Doha Declaration confirmed, amongst others, the right of WTO...

New requirements for prescribing information.(Regulatory Action and News)
January 1, 2006... United States of America -- The Food and Drug Administration (FDA) is issuing final regulations amending the content and format of prescribing information for human drug and biological products. The final rule revises the current regulations...

Paediatric hepatitis A vaccine approval extended.(Regulatory Action and News)
January 1, 2006... United States of America -- The Food and Drug Administration (FDA) has approved an application to allow use of the paediatric/adolescent formulation of hepatitis A vaccine, inactivated (Havrix[R]) for persons 1-18 years of age. Previously,...

Electronic individual case safety reports: testing has begun.(Regulatory Action and News)(Brief article)
January 1, 2006... United Kingdom -- The Medicines and Healthcare Products Regulatory Agency (MHRA) is preparing the introduction of mandatory electronic transmission of an individual case safety report (ICSR) between marketing authorization holders (MAHs) and...

First biosimilar medicinal product approval.(Regulatory Action and News)(Brief article)
January 1, 2006... European Union -- The European Medicines Agency (EMEA) has adopted the first positive opinion for a similar biological medicinal product. The product, Omnitrope[R], contains somatrepin, a recombinant-DNA growth hormone. It is intended for the...

Tenecteplase withdrawn for commercial reasons.(Regulatory Action and News)(Brief article)
January 1, 2006... European Union -- Tenecteplase is net marketed anywhere in the European Union. On 28 June 2005, the manufacturer notified the European Commission of its decision to withdraw the Community Marketing Authorization for Tenecteplase Boehringer...

Immune globulin approved for primary immune deficiency disease.(Regulatory Action and News)(Brief article)
January 1, 2006... United States of America -- The Food and Drug Administration has approved the first immune globulin product for subcutaneous injection for the prevention of serious infections in patients with primary immune deficiency diseases (PIDD)....

Cetuximab approved for head and neck cancer.(Regulatory Action and News)
January 1, 2006... United States of America -- The Food and Drug Administration (FDA) has announced approval of cetuximab (Erbitux[R]) for use in combination with radiation therapy to treat patients with squamous cell cancer of the head and neck (SCCHN) that...

Selegiline patch for depression.(Regulatory Action and News)
January 1, 2006... United States of America -- The Food and Drug Administration has approved the first transdermal patch (Emsam[R]) for use in treating major depression. The once a day patch works by delivering the monoamine oxidase inhibitor (MAOI) selegiline....

Ketamine now a classified drug.(Regulatory Action and News)(Brief article)
January 1, 2006... United Kingdom -- As of 1 January 2006, Ketamine has become a controlled drug in the United Kingdom. This step has been taken because of its increasing misuse within the country. It is now a Class C drug, in Schedule 4 part 1, under the...

The importance of independent drug bulletins.(Recent Publications, Information and Events)(Brief article)
January 1, 2006... Using medicines safely and effectively requires that information is available to prescribers and others who give advice about medicines. Providing information in an impartial, objective and accessible way is a challenge and one effective...

Patient-centred healthcare and safety.(Recent Publications, Information and Events)
January 1, 2006... The International Alliance of Patients' Organizations (IAPO) organized the second Global Patients Congress in Barcelona, Spain from 22-24 February 2006. The congress brought together over 120 patient leaders from around the world, together...

Boletin Farmacos: medicines information in Spanish.(Recent Publications, Information and Events)
January 1, 2006... In April 1997, during the First international conference on improving use of medicines, a network was created entitled Researchers and promoters of the appropriate use of medicines in Latin America (RUAMAL). Publication of an electronic...

Antiretroviral programmes in low resource settings.(Recent Publications, Information and Events)
January 1, 2006... The promise of improved funding through international initiatives has meant that HIV infection is treatable in developing and transitional countries. Resources such as antiretroviral medicines (ARV) and diagnostics are increasingly becoming...

Developing countries and paediatric drug information.(Recent Publications, Information and Events)
January 1, 2006... The British National Formulary has published a British National Formulary for Children (BNFC) which is available online. The website is accessible free of charge for certain countries. (To find out which countries can access BNFC see...

Prudent use of antibiotics.(Recent Publications, Information and Events)
January 1, 2006... The Alliance for the Prudent Use of Antibiotics (APUA) Newsletter has been published quarterly since 1982. The Newsletter contains expert information on antibiotic use and resistance for healthcare practitioners, researchers and policy...

International Network for Rational Use of Drugs now online.(Recent Publications, Information and Events)
January 1, 2006... The International Network for Rational Use of Drugs (INRUD) was established in 1989 to design, test, and disseminate effective strategies and to improve the way drugs are prescribed, dispensed and used, with particular emphasis on resource...

Rational medicines management course for diseases of poverty.(Recent Publications, Information and Events)
January 1, 2006... Health is an intrinsic human right as well as a central input to poverty reduction and socioeconomic development. Cost-effective interventions including medicines for controlling major diseases exist, but a lack of money for health and a...

Revised WHO treatment recommendations for malaria.(General Information)
January 1, 2006... Global malaria control is being threatened on an unprecedented scale by rapidly growing resistance of Plasmodium falciparum to conventional monotherapies such as chloroquine, sulfadoxine-pyrimethamine (SP) and amodiaquine. Multidrug-resistant...

Quality assurance: latest guidance.(General Information)
January 1, 2006... The purpose of the WHO Expert Committee on Specifications for Pharmaceutical Preparations is to provide guidance to WHO and Member States concerning the quality of medicines. Within this broad mandate, it focuses on good manufacturing...

WHO clinical trial registry initiative: update.(General Information)(world health organization)
January 1, 2006... As previously reported (1), a registry platform has been set up within WHO to link registers into a comprehensive network and provide harmonization and information for the initiative. The Scientific Advisory Group (SAG) is composed of...

International nonproprietary names for pharmaceutical substances (INN).
January 1, 2006... RECOMMENDED International Nonproprietary Names: List 55 Notice is hereby given that, in accordance with paragraph 7 of the Procedure for the Selection of Recommended International Nonproprietary Names for Pharmaceutical Substances [Off....