WHO Drug Information articles from June 2005

WHO Drug Information archives from June 2005

Unfinished business: clinical pharmacology and world health.(Personal Perspectives)
June 22, 2005... Clinical pharmacology has existed for just over 40 years and is a relative newcomer to the range of clinical specialties. It took its origins from the development of methods for the formal testing of new medicines in man--especially the...

Transdermal fentanyl: abuse by adolescents.(Safety and Efficacy Issues)
June 22, 2005... Canada -- Fentanyl transdermal system (Duragesic[R]) has been marketed in Canada since 1992 and is indicated for the management of chronic pain in patients requiring continuous opioid analgesia for pain that is not optimally managed with weak...

Safety of fentanyl transdermal patches.(Safety and Efficacy Issues)
June 22, 2005... United States of America -- The Food and Drug Administration (FDA) is investigating reports of death and other serious side effects from overdoses of fentanyl in patients using fentanyl transdermal (skin) patches for pain control. Deaths and...

Rosiglitazone: decreased high-density lipoprotein cholesterol.(Safety and Efficacy Issues)
June 22, 2005... Canada -- Rosiglitazone (Avandia[R]) is a member of the thiazolidinedione family of oral hypoglycaemic agents used to improve glycaemic control by increasing insulin sensitivity in muscle and adipose tissue and inhibiting hepatic...

Ibuprofen: Stevens-Johnson syndrome.(Safety and Efficacy Issues)
June 22, 2005... Canada -- Stevens-Johnson syndrome (SJS) is a severe blistering rash affecting both skin and mucous membranes. The majority of cases have been attributed to drug exposures (1,2). The reaction begins with burning and painful lesions on the face...

Stringent conditions for COX-2 inhibitors.(Safety and Efficacy Issues)
June 22, 2005... New Zealand -- The class of medicines known as COX-2 inhibitors will stay on the market, but with considerably stronger warnings for their use and the requirements for pharmaceutical companies to collect and report information on usage....

Sildenafil, tadalafil and vardenafil: eye problems reported.(Safety and Efficacy Issues)(Brief Article)
June 22, 2005... United States of America -- The Food and Drug Administration (FDA) has approved updated labelling for tadalafil (Cialis[R]), vardenafil (Levitra[R]) and sildenafil (Viagra[R]) to reflect a small number of post-marketing reports of sudden vision...

Nesiritide: safety report and measures.(Safety and Efficacy Issues)
June 22, 2005... United States of America -- The Food and Drug Administration has posted the recommendations of an expert panel of cardiology and heart failure clinicians with regard to nesiritide (Natrecor[R]), the first member of a new drug class, human...

Mifepristone, sepsis and blood infection.(Safety and Efficacy Issues)
June 22, 2005... United States of America -- The Food and Drug Administration (FDA) is investigating serious adverse events associated with mifepristone (Mifeprex[R]) and highlighting the risk of sepsis or blood infection when undergoing medical abortion using...

Mifepristone: revised safety information.(Safety and Efficacy Issues)
June 22, 2005... Switzerland -- The Health Authority, Swissmedic, has released new information for health professionals concerning rare complications of sepsis and haemorrhage reported from USA and Canada following use of mifepristone (Mifegyne[R]) and...

Suicidality with SSRIs in adults.(Safety and Efficacy Issues)
June 22, 2005... Australia -- In 2004, the Australian Adverse Reactions Advisory Committee (ADRAC) published a statement on the use of SSRI antidepressants in children and adolescents in view of evidence that use of these agents in these age groups was...

Ezetimibe and muscle disorders.(Safety and Efficacy Issues)
June 22, 2005... Australia -- Ezetimibe (Ezetrol[R]) lowers lipids by inhibiting the intestinal absorption of cholesterol and is indicated for the treatment of hypercholesterolaemia. Out of 144 Australian reports received with ezetimibe since registration in...

Pathological gambling with cabergoline.(Safety and Efficacy Issues)(Brief Article)
June 22, 2005... Australia -- In the past 2 years the Australian Adverse Reactions Advisory Committee (ADRAC) has received 4 reports describing the development of pathological gambling in association with cabergoline (Cabaser[R]). These are the only 4 reports...

Icodextrin peritoneal dialysis solution: falsely elevated blood glucose readings.(Safety and Efficacy Issues)
June 22, 2005... Singapore -- There have been recent adverse reports in Australia, Canada and the United Kingdom of injuries caused by falsely elevated blood glucose readings in diabetic patients who are using peritoneal dialysis solution that contains...

New requirements for pseudoephedrine products.(Safety and Efficacy Issues)
June 22, 2005... United States of America -- Pharmacies that engage in over-the-counter sales of tablet forms of products containing ephedrine, pseudoephedrine, or norpseudoephedrine must keep those products behind the pharmacy counter, or in a locked case...

Efalizumab: warning of thrombocytopenia.(Safety and Efficacy Issues)(Brief Article)
June 22, 2005... United States of America -- The manufacturer of efalizumab (Raptiva[R]) has informed health care professionals of important new safety information. Efalizumab is indicated for the treatment of adult patients (18 years or older) with chronic...

Antiretrovirals: HIV, hepatic impairment and HBV/HCV.(Safety and Efficacy Issues)
June 22, 2005... European Union -- During 2002, the European Medicines Agency (EMEA) requested the marketing authorisation holders for all licensed antiretroviral medicinal products in Europe to conduct a retrospective review from clinical trials and post...

Monograph for cultivation of herbal antimalarial: Artemisia annua.(Herbal Medicines)
June 22, 2005... World Health Organization -- Recent estimates of the global burden of malaria have shown increasing levels of morbidity and mortality, particularly in Africa. Key among the factors contributing to the increase is the widespread resistance of...

Ayurvedic medicines and heavy metals.(Herbal Medicines)
June 22, 2005... Canada -- Health Canada is warning consumers not to use certain Ayurvedic medicinal products because they contain high levels of heavy metals such as lead, mercury and/or arsenic. Health Canada is taking action to remove these products from the...

National policy on regulation of herbal medicines.(Herbal Medicines)
June 22, 2005... World Health Organization -- Herbal medicines have always played an important role in human health. There are great differences among countries in the definition and categorization of herbal medicines: a single medicinal plant may be defined as...

Regulatory guidelines for complementary medicines.(Herbal Medicines)
June 22, 2005... Australia -- In May 2003, the Australian Government established the Expert Committee on Complementary Medicines to review regulatory, health system and industry structures. The committee made 49 recommendations on a range of issues, including...

Hydromorphone extended release suspended.(Regulatory Action and News)(Brief Article)
June 22, 2005... United States of America -- On request of the Food and Drug Administration (FDA), the sponsor of hydromorphone hydrochloride (Palladone[R]) extended release capsules, a potent narcotic painkiller, has agreed to suspend sales and marketing...

New drug safety initiative.(Regulatory Action and News)(Brief Article)
June 22, 2005... United States of America -- The Food and Drug Administration (FDA) is launching a new programme to make drug safety information publicly available in an easily accessible format. Patients are taking a more active role in their healthcare, the...

Deregistration of thioridazine.(Regulatory Action and News)
June 22, 2005... Singapore -- Thioridazine, a phenothiazine antipsychotic agent, is known to be associated with an increased risk of QT prolongation, cardiac arrhythmias and sudden death. Following emerging evidence of these safety concerns since 2000, the...

Caution on self medication.(Regulatory Action and News)
June 22, 2005... Singapore -- The Health Sciences Authority (HSA) has advised the public not to purchase any medicinal product from dubious sources such as street peddlers, unlicensed premises or via the Internet, as the safety, efficacy and quality of such...

Table: examples of adulterated products.
June 22, 2005... Table: Examples of adulterated products Product name Use Adulterant(s) Jamu Kenis Pil, For symptoms such as Per pill: Borobudur, Semarang, frequent feeling of glibenclamide 0.03 mg....

European marketing authorizations.(Regulatory Action and News)
June 22, 2005... European Union -- The Committee for Medicinal Products for Human Use (CHMP) gave positive opinions on initial marketing authorization applications for the following products. * Aptivus[R] (tipranavir), from Boehringer Ingelheim...

Tigecycline: first-in-class antibiotic approved.(Regulatory Action and News)
June 22, 2005... United States of America -- The Food and Drug Administration (FDA) has approved tigecycline (Tygacil[R]), a novel I.V. antibiotic with a broad spectrum of antimicrobial activity, including activity against methicillin-resistant Staphylococcus...

Highlights of the 14th Model List of Essential Medicines.(Essential Medicines)
June 22, 2005... The WHO Expert Committee on the Selection and Use of Essential Medicines met in Geneva in March 2005. Their task was to evaluate evidence-based material relating to the maintenance and updating of the Model List of Essential Medicines. The...

WHO model list of essential medicines: core list (revised March 2005).
June 22, 2005... 1: Anaesthetics 1.1 General anaesthetics and oxygen * halothane inhalation ketamine injection, 50 mg (as hydrocholoride)/ ...

Intellectual property protection: impact on public health.(Access to Medicines)
June 22, 2005... The World Trade Organization (WTO) is an international organization of 148 Member countries dealing with the rules of trade. In joining the WTO, Members adhere to specific agreements. Of these agreements, Trade-Related Aspects of Intellectual...

International Pharmacopoeia: fourth edition in development.(The International Pharmacopoeia)
June 22, 2005... World Health Organization--The fourth edition of The International Pharmacopoeia is now in preparation. The main purpose of this new edition is to consolidate the five separate volumes of the current third edition and to include those new...

International Nonproprietary Names for Pharmaceutical Substances (INN).
June 22, 2005... RECOMMENDED International Nonproprietary Names: List 54 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....