WHO Drug Information articles from September 2005

WHO Drug Information archives from September 2005

Avian influenza: impact on health programmes.(Drug Management)
September 22, 2005... Avian influenza is an infectious disease of birds caused by type A strains of the influenza virus. The disease, which was first identified in Italy more than 100 years ago, occurs worldwide. All birds are thought to be susceptible to...

Influenza antiviral medicinal products for potential use during a pandemic *.(Drug Management)
September 22, 2005... Occasionally, emerging influenza A virus strains undergo major changes in their genes, especially in the neuraminidase (NA) and haemagglutinin (HA) genes. This may be due to an adaptation of an avian or porcine strain to the human host or to...

Safety challenges of preventing malaria during pregnancy.(Safety and Efficacy Issues)
September 22, 2005... Malaria is a significant cause of mortality and morbidity among pregnant women in malaria endemic countries including Ghana where it accounts for nearly 10% of all deaths in pregnancy. It is also associated with anaemia and low birth weight...

WHO International Drug Monitoring Programme: 28th meeting.(Safety and Efficacy Issues)
September 22, 2005... The Twenty-eighth Annual Meeting of Representatives of National Centres participating in the WHO Programme for International Drug Monitoring was held from 26 to 29 September 2005 in Geneva, Switzerland. The meeting focused on several key...

Statins and memory loss.(Safety and Efficacy Issues)
September 22, 2005... Canada -- The role of HMG-CoA reductase inhibitors, or statins, in cardiovascular protection is well established. However, evidence in the current literature is conflicting as to the effect of statins on cognitive function (1). It has been...

New safety information on long-acting beta-2 agonists.(Safety and Efficacy Issues)
September 22, 2005... Canada -- Health Canada has advised of a possible increased risk of asthma-related deaths associated with long-acting beta-2 agonists. The medications involved are salmeterol, (Serevent[R]), formoterol, (Foradil[R] and Oxeze[R]); as well...

Meningococcal vaccine and Guillain Barre syndrome.(Safety and Efficacy Issues)
September 22, 2005... United States of America -- The Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) are alerting consumers and health care providers to five reports of Guillain Barre syndrome (GBS) following administration...

Trastuzumab and possible cardiotoxicity.(Safety and Efficacy Issues)
September 22, 2005... United States of America -- The manufacturer of trastuzumab (Herceptin[R]) has updated health care professionals on cardiotoxicity information obtained from the National Surgical Adjuvant Breast and Bowel Project (NSABP) study (B-31), a...

Trastuzumab: interim treatment recommendations.(Safety and Efficacy Issues)
September 22, 2005... France -- The French Medicines Agency (Afssaps) has advised health care professionals of new information concerning use of trastuzumab (Herceptin[R]) as adjuvant treatment in breast cancer associated with over-expression of the HER2 protein....

Oseltamivir paediatric adverse events.(Safety and Efficacy Issues)
September 22, 2005... United States of America -- At its meeting on 18 November 2005, the Pediatric Advisory Committee (PAC) will review the safety report for oseltamivir (Tamiflu[R]). The review will include adverse event reports, a literature review, and...

Duloxetine hydrochloride and hepatic effects.(Safety and Efficacy Issues)(Brief article)
September 22, 2005... United States of America -- The manufacturer of duloxetine hydrochloride (Cymbalta[R]) has informed health care professionals of new safety information regarding hepatic injury (including hepatitis and cholestatic jaundice) obtained from...

Intrathecal baclofen: incidents with implantable drug pump system.(Safety and Efficacy Issues)
September 22, 2005... Canada -- Baclofen (Lioresal[R]) is a muscle relaxant and antispastic agent (1). Intrathecal baclofen (ITB) is indicated for the management of severe spasticity in patients with spinal cord injury or multiple sclerosis unresponsive to oral...

Ibritumomab tiuxetan therapeutic regimen: cutaneous reactions.(Safety and Efficacy Issues)(Brief article)
September 22, 2005... United States of America -- The manufacturer of ibritumomab tiuxetan (Zevalin[R]) has advised health care professionals of new safety information involving severe cutaneous or mucocutaneous reactions, some with fatal outcome, which have been...

Interactions with implantable medical devices.(Safety and Efficacy Issues)
September 22, 2005... Canada/France -- Patients with active implantable medical devices and systems (AIMDS) are at risk of injury from interactions between the AIMDS and other medical devices used for diagnostic or therapeutic purposes. Such interactions could...

Liquid chemical polymer and serious adverse events.(Safety and Efficacy Issues)
September 22, 2005... United States of America -- The manufacturer of Enteryx[R] Procedure Kits and Enteryx[R] Injector Single Packs has informed health care professionals of serious adverse events, including death, occurring in patients treated for...

Atomoxetine and suicidal thinking in children and adolescents.(Safety and Efficacy Issues)
September 22, 2005... United States of America -- the Food and Drug Administration (FDA) has directed the manufacturer of atomoxetine (Strattera[R]) approved for the treatment of attention deficit hyperactivity disorder (ADHD) in paediatric and adult patients, to...

Paroxetine: first trimester exposure and congenital malformations.(Safety and Efficacy Issues)
September 22, 2005... Canada -- The manufacturer of paroxetine (Paxil[R]) has informed health care professionals of important new safety information regarding use during the first trimester of pregnancy. The preliminary report of a retrospective...

Canada and the "Jean Chretien Pledge to Africa".(Access to Medicines)(effects of WTO Agreement on Trade-Related Intellectual Property Rights)
September 22, 2005... On 30 August 2003, negotiations among World Trade Organization (WTO) Members resulted in a landmark decision (the "Decision") waiving two compulsory licensing provisions (Articles 31[f] and [h]) of the WTO Agreement on Trade-Related...

Safety update on paediatric use of oseltamivir.(Regulatory Action and News)
September 22, 2005... European Union -- A potential influenza pandemic remains currently of high public interest and the European Medicines Agency (EMEA) has provided a safety update on oseltamivir (Tamiflu[R]) see page 274). Oseltamivir is an antiviral...

Influenza virus composition for 2006 southern hemisphere winter.(Regulatory Action and News)
September 22, 2005... World Health Organization--It is recommended that vaccines to be used in the 2006 season (southern hemisphere winter) contain the following: * an A/New Caledonia/20/99(H1N1)-like virus; * an A/California/7/2004(H3N2)-like virus. (The...

International biosafety guidelines for influenza vaccine production.(Regulatory Action and News)
September 22, 2005... World Health Organization--The WHO Expert Committee on Biological Standardization met in Geneva from 24-28 October 2005. One of the new guidelines that was established describes international biosafety expectations for both pilot-scale and...

Veralipride: withdrawal following review of risk/benefit.(Regulatory Action and News)(Brief article)
September 22, 2005... Spain -- The Spanish Agency for Medicines and Health Products has announced the marketing withdrawal of the menopausal treatment veralipride (Agreal[R]), an antidopamine agent marketed in Spain since 1983 for the treatment of hot flushes and...

Pemoline: liver injury risk and market withdrawal.(Regulatory Action and News)
September 22, 2005... United States of America -- The Food and Drug Administration (FDA) has concluded that the overall risk of liver toxicity from Cylert[R] and generic pemoline products outweighs the benefits of this drug. In May 2005, the manufacturer of...

Nelarabine approved for leukaemia and lymphoma.(Regulatory Action and News)
September 22, 2005... United States of America -- The Food and Drug Administration (FDA) has announced the approval of nelarabine (Arranon [R]) for marketing in the United States under the Orphan Drug and Accelerated Approval Program. This is a new drug to treat...

EMEA proposes new, faster scientific advice procedure.(Regulatory Action and News)
September 22, 2005... European Union--The European Medicines Agency (EMEA) has launched a two-month public consultation exercise on proposed improvements to the way it provides scientific advice on the research and development of new medicines. The provision of...

Withdrawal of Infanrix HepB[R].(Regulatory Action and News)(Brief article)
September 22, 2005... European Union -- On 25 April 2005 the European Commission adopted a decision withdrawing the marketing authorization for the medicinal product for human use "Infanrix HepB". It followed the notification by the marketing authorisation holder...

Precautionary suspension of Hexavac[R]: lowered immunogenicity.(Regulatory Action and News)(Brief article)
September 22, 2005... Switzerland -- Swissmedic has advised health care professionals of suspension of the marketing authorization for Hexavac[R]. Hexavac[R] is a combined paediatric vaccine offering protection against diphtheria, tetanus, pertussis,...

Environmental risk assessment for human and veterinary medicinal products.(Regulatory Action and News)
September 22, 2005... European Union -- The European Medicines Agency held a conference with interested parties on 27-28 October 2005 to discuss the current state and future developments in the area of environmental risk assessment for human and veterinary...

Promoting drug use in the community.(Recent Publications, Information and Events)(Brief article)
September 22, 2005... The International Training course on Promoting Rational Drug Use in the Community is a groundbreaking 10-day course developed by WHO to respond to a clear need for more effective planning, research and implementation of rational medicine use...

Registration of fixed dose combinations.(Recent Publications, Information and Events)(Brief article)
September 22, 2005... Fixed-dose combination (FDC) medicines are increasingly used in the treatment of a wide range of conditions and are particularly useful in the management of public health infections such as HIV, tuberculosis and malaria. FDCs have...

Sources and prices of HIV medicines and diagnostics.(Recent Publications, Information and Events)
September 22, 2005... The World Health Organization has published the 2005 Sources and prices of selected medicines and diagnostics for people living with HIV/AIDS. This report, on finished products of selected HIV-related medicines and diagnostics, includes over...

Screening guidelines for women exposed to DES in utero.(Recent Publications, Information and Events)(Brief article)
September 22, 2005... Australia -- New guidelines on Screening to Prevent Cervical Cancer: Guidelines for the Management of Asymptomatic Women with Screen Detected Abnormalities, was published on 9 June 2005. These guidelines contain a section concerning women...

The Blue Guide on advertising.(Recent Publications, Information and Events)
September 22, 2005... The new Blue Guide on Advertising and Promotion of Medicines in the UK has been lunched on 7 November 2005. The guide explains the regulations and provides clarification on the Agency's interpretation. Advertising, including that of...

Chronic airways disease guide.(Recent Publications, Information and Events)
September 22, 2005... Prevalence of chronic airways diseases such as asthma, chronic obstructive pulmonary disease (COPD) and allergic rhinitis are on the increase. There is a great need for more and better care of these diseases. Many guidelines are often...

Priority medicines for Europe and the world.(Recent Publications, Information and Events)
September 22, 2005... In a Europe which is expanding and playing a pivotal role in many global challenges, this report has been developed to identify pharmaceutical gaps undermining efforts to control those diseases of public health importance which have so far...

Monograph for oral powders.(International Pharmacopoeia)
September 22, 2005... The International Pharmacopoeia is collaborating with manufacturers, independent analytical drug quality control laboratories, national and regional pharmacopoeial bodies, research, governments, and regulatory bodies to provide a general...

Launch of new medicines website.
September 22, 2005... Based largely on the results of a recently conducted user survey, the World Health Organization has developed a new medicines website at http://www.who.int/medicines/ The newly designed website provides direct links to WHO medicines...

International Nonproprietary Names for Pharmaceutical Substances (INN).
September 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...