WHO Drug Information articles from June 2004

WHO Drug Information archives from June 2004

Improving pharmacovigilance practice beyond spontaneous reporting *.(Safety and Efficacy Issues)
June 22, 2004... Pharmacovigilance is a public health practice aimed at analysing and managing the risks of medicinal products once they have been marketed. According to this definition, pharmacovigilance can be divided into two distinct phases: risk analysis...

Spironolactone and ACE inhibitors: link to hyperkalaemia.(Safety and Efficacy Issues)
June 22, 2004... Heart failure affects approximately 5 million persons annually in Canada and the United States (1). Medications are the mainstay of therapy, and in the past two decades there has been a shift away from the use of diuretics and cardiac...

Pulmonary toxicity with long-term nitrofurantoin.(Safety and Efficacy Issues)
June 22, 2004... Nitrofurantoin is indicated for the treatment of urinary tract infections (1, 2). To date, the Australian Drug Reactions Advisory Committee (ADRAC) has received 576 reports of suspected adverse reactions to nitrofurantoin, with pulmonary...

Cardiac valvulopathy and pergolide.(Safety and Efficacy Issues)
June 22, 2004... Pergolide is a dopamine agonist and ergot derivative indicated for the adjunctive treatment of Parkinson disease, An association has recently been identified between pergolide and valvular heart disease (1). This evidence has been subsequently...

Tramadol-warfarin interaction.(Safety and Efficacy Issues)
June 22, 2004... Some individuals are susceptible to interaction between tramadol and warfarin. The Australian Drug Reactions Advisory Committee (ADRAC) has received 11 reports of this interaction leading to an increase in INR (international normalized ratio)...

Fluoroquinolones and warfarin interactions.(Safety and Efficacy Issues)
June 22, 2004... Fluoroquinolones are primarily used to treat respiratory and urinary tract infections, prostatitis, septicaemia, and skin, soft-tissue, bone and joint infections (1-6), Cases of increased anticoagulant activity have been reported in patients...

Suspected interactions with anticoaglants.(Safety and Efficacy Issues)
June 22, 2004... In September 2003 the United Kingdom Committee on Safety of Medicines highlighted the possible interaction between warfarin and cranberry juice and advised patients taking warfarin to limit or avoid drinking cranberry juice (1). They had...

Dura mater graft: association with Creutzfeldt-Jakob disease.(Safety and Efficacy Issues)
June 22, 2004... Tutoplast Dura[R] mater is commercially processed dura mater obtained from human donors (1). Regulated as a medical device, Tutoplast Dura[R] mater was available in Canada between January 1982 and April 2002 for use in various surgical...

Leflunomide: serious multisystem adverse effects.(Safety and Efficacy Issues)
June 22, 2004... Leflunomide is an effective disease-modifying agent (DMARD) for rheumatoid arthritis (1). Its use has been associated with significant and serious adverse reactions involving haematological, hepatic, immune, dermatological and respiratory...

Myopathy with statins: importance of CK levels.(Safety and Efficacy Issues)
June 22, 2004... Reports of myopathy and rhabdomyolysis with statins are a reminder to prescribers to measure creatine kinase (CK) levels in patients presenting with muscle pain or weakness. The risk of myopathy may be increased by high doses of statins,...

Inhaled corticosteroids and skin atrophy.(Safety and Efficacy Issues)
June 22, 2004... Inhaled corticosteroids can cause skin atrophy. This adverse effect may be exacerbated by sun exposure, possibly via a cumulative mechanism. The risk of skin atrophy can be minimized by using the lowest possible maintenance dose of inhaled...

Dermatological adverse drug reactions.(Safety and Efficacy Issues)
June 22, 2004... The skin is the organ most frequently affected by adverse drug reactions (ADRs). In 2003, dermatological ADRs accounted for 46% of all adverse reactions reported to the Pharmacovigilance Unit of the Health Sciences Authority, Singapore. Most of...

Visual disturbances with COX-2 inhibitors.(Safety and Efficacy Issues)
June 22, 2004... Acute, temporary, and sometimes severe visual disturbances have been reported with celecoxib and rofecoxib use. The eyesight changes appear to be completely reversible on withdrawal of the COX-2 inhibitor. Similar events have occurred with...

Clopidogrel, haemorrhage and haematological disorders.(Safety and Efficacy Issues)
June 22, 2004... Clopidogrel is indicated for the prevention of myocardial infarction and stroke in patients with atherosclerosis and, in combination with acetyl-salicylic acid, for the treatment of acute coronary syndrome. It inhibits platelet aggregation,...

Reports of diarrhoea with carvedilol.(Safety and Efficacy Issues)
June 22, 2004... Carvedilol is a non-cardioselective beta-blocker with alpha blocking activity (1). It is indicated for the management of essential hypertension, angina pectoris and as adjunctive therapy in chronic heart failure (2). The New Zealand Centre for...

Herbal remedy containing glibenclamide.(Safety and Efficacy Issues)
June 22, 2004... Singapore -- A female patient was hospitalized recently for diabetic ketoacidosis, characterized by lethargy, polyuria and polydipsia. The patient had apparently defaulted follow-up with her doctor and stopped taking her anti-diabetic...

Safety of vaccine products under development.(Vaccines and Biomedicines)
June 22, 2004... The Global Advisory Committee on Vaccine Safety (GACVS) is an expert clinical and scientific advisory body to WHO established to deal independently and with scientific rigour to vaccine safety issues of global importance (1). The GACVS held its...

Dengue vaccine safety update.(Vaccines and Biomedicines)
June 22, 2004... Dengue virus is a flavivirus with four serotypes and type-specific protective immunity. At least eight vaccines against dengue virus infection are currently under development;, two are at the stage of phase II clinical evaluation. Sensitization...

Development of vaccines for SARS and avian influenza.(Vaccines and Biomedicines)
June 22, 2004... A joint workshop has been held between the Ministry of Science and Technology of China and the World health Organization on development of vaccines against SARS and avian influenza. The event took place in China in March 2004 and was attended...

Potential effects of SSRIs and other antidepressants on newborns.(Regulatory and Safety Action)
June 22, 2004... Canada -- Health Canada is advising that newborns may be adversely affected when pregnant women take selective serotonin reuptake inhibitors (SSRIs) and other newer antidepressants during the third trimester of pregnancy. The advisory is...

Deregulation of 371 OTC products.(Regulatory and Safety Action)
June 22, 2004... Japan -- Until now, regulations identify pharmaceutical products as prescription-only and over-the-counter medicines for sale in pharmacies and drug stores. Other parapharmacy products, or "quasi-drugs"--defined as having mild action on the...

Critical path initiative: standardizing trial data.(Regulatory and Safety Action)
June 22, 2004... United States of America--The Food and Drug Administration (FDA) has announced development of the Study Data Tabulation Model (SDTM) (1) for sponsors of human drug clinical trials. It is expected that this will lead to greater efficiencies in...

Fixed dose combination drug products approved for HIV.(Regulatory and Safety Action)
June 22, 2004... United States of America -- The Food and Drug Administration (FDA) has announced the approvals of abacavir/lamivudine (Epzicom[R]) and tenofovir disoproxil/emtricitabine (Truvada[R]), two fixed-dose combination treatments for HIV-1 infection....

Acetylcysteine labelling changes.(Regulatory and Safety Action)
June 22, 2004... Singapore -- Changes have been made to the labelling for acetylcysteine (Parvolex[R]) including the addition of new sections on carcinogenicity and mutagenicity, impairment of fertility, use in lactation, paediatric use, use in the elderly and...

Rituximab and hepatitis B reactivation.(Regulatory and Safety Action)
June 22, 2004... Canada -- Rituximab (Rituxan[R]) is indicated for the treatment of patients with relapsed or refractory low grade or follicular, CD20-positive, B cell non-Hodgkin lymphoma and patients with CD20-positive, diffuse large B-cell non-Hodgkin...

Rosuvastatin and Asian subjects.(Regulatory and Safety Action)
June 22, 2004... Singapore -- The manufacturer of rosuvastatin (Crestor[R])) has submitted a labelling amendment to indicate information on a twofold increase in median AUC after a single dose (40 mg) of rosuvastatin given to Chinese patients in Singapore...

Trazodone, interactions and CYP 3A4 metabolism.(Regulatory and Safety Action)
June 22, 2004... Canada -- The manufacturer of trazodone hydrochloride (Desyrel[R]), indicated for the symptomatic relief of depressive illness, has advised health care professionals of important safety information concerning drug interactions with CYP 3A4...

Phenol: new labelling data.(Regulatory and Safety Action)
June 22, 2004... Singapore -- Oily phenol injection is now contraindicated for use in patients hypersensitive to phenol or almond oil, in neonates and children. Labelling changes for products containing phenol include new sections on clinical trials,...

Docetaxel for early stage breast cancer.(Regulatory and Safety Action)
June 22, 2004... United States of America -- The Food and Drug Administration (FDA) has approved docetaxel (Taxotere[R]) for use in combination with doxorubicin and cyclophosphamide for the adjuvant (post surgery) treatment of patients with operable,...

Imiquimod approved for keratosis.(Regulatory and Safety Action)
June 22, 2004... United States of America -- The Food and Drug Administration (FDA) has announced approval of imiquimod (Aldara[R]) for the treatment of superficial basal cell carcinoma (sBCC). Superficial basal cell carcinoma is usually treated by surgical...

Cetuximab for metastatic colorectal cancer.(Regulatory and Safety Action)
June 22, 2004... United States of America -- The manufacturer has announced approval of cetuximab (Erbitux[R]), an antibody for use in combination with irinotecan in the treatment of patients with metastatic colorectal cancer who are refractory to...

Tiotropium approved for bronchospasm.(Regulatory and Safety Action)
June 22, 2004... United States of America -- A new treatment for obstructive pulmonary disease, tiotropium bromide (Spiriva HandiHaler[R], has been approved by the Food and Drug Administration. Tiotropium, an antimuscarinic agent, is indicated for the treatment...

European antimicrobial expert group established.(Regulatory and Safety Action)
June 22, 2004... European Union -- The Committee on Veterinary Medicinal Products has established a Scientific Advisory Group on Antimicrobials to provide expertise on matters relating to antimicrobial substances. The Group will also advise on critical aspects,...

Ciclesonide: novel asthma treatment.(Regulatory and Safety Action)
June 22, 2004... Australia -- The Therapeutic Goods Administration has approved ciclesonide (Alvesco[R]) a new-generation inhaled corticosteroid with novel release and distribution properties for the treatment of asthma in adults and adolescents 12 years of age...

Assessment reports on WHO prequalified HIV medicines now publicly accessible.(HIV Medicines)
June 22, 2004... More HIV/AIDS medicines have been added to the World Health Organization (WHO) prequalification list (1,2). At the same time, the product assessment reports on quality and bioequivalence of triple fixed-dose combination (FDCs) antiretrovirals...

Efficacy of dual antiretroviral regimen in mother-to-child transmission of HIV.(HIV Medicines)
June 22, 2004... In industrialized nations, the use of HAART (highly active antiretroviral therapy) in pregnant women along with an optimal package of interventions, including cesarean section and formula feeding, has reduced the rate of mother-to-child...

Monitoring of antiretroviral safety and efficacy.(HIV Medicines)
June 22, 2004... Many countries in Africa are introducing combinations of antiretrovirals (ARV) as part of WHO's 3 by 5 Strategy to provide antiretroviral treatment to 3 million people by 2005. Most of the first-line drugs are now available as multisource...

Neglected diseases.(Essential Medicines)
June 22, 2004... Over the last few decades, progress in science has enabled increasingly sophisticated medicines to be developed to cure a wide variety of diseases. Some infectious tropical diseases, however, have been progressively marginalized by research...

A portfolio for research and development.(Essential Medicines)
June 22, 2004... Neglected diseases such as leishmaniasis, trypanosomiasis, Chagas disease and malaria have a devastating impact on the world's poor. DNDi is addressing this lack of new, improved drugs for these treatable, infectious tropical diseases with an...

Malaria patients enter DNDi clinical trials.(Essential Medicines)
June 22, 2004... A year after its launch, the Drugs for Neglected Diseases Initiative (DNDi) is starting clinical trials of two fixed-dose drug combinations against malaria. To ensure a balanced portfolio of drugs in the pipeline, DNDi mixes quick-fix with...

Corrigendum for alcuronium: WHO Model Formulary 2004.(Essential Medicines)
June 22, 2004... The WHO Model Formulary is an indispensable source of independent information on essential medicines for policy makers and prescribers. It describes how to make effective use of medicines on the WHO Model List of Essential Medicines and for...

Indinaviri sulfas (2nd draft) Indinavir sulfate.(Consultation Documents)
June 22, 2004... [C.sub.36][H.sub.47][N.sub.5][O.sub.4], [H.sub.2][O.sub.4]S Relative molecular mass: 711.9 Chemical name: (2S)-1-[(2S,4R)-4-benzyl-2-hydroxy-5-[[(1S, 2R) -2-hydroxy-2,3-dihydro-1H-inden-1-yl]amino]-5-oxopentyl]...

Nelfinaviri mesilas (2nd draft) Nelfinavir mesilate.(Consultation Documents)
June 22, 2004... [C.sub.32][H.sub.45][N.sub.3][O.sub.4]S, [CH.sub.4][O.sub.3]S Relative molecular mass: 663.9 Chemical name: (3S,4aS, 8aS)-N-(1, 1-dimethylethyl)-2-[(2R, 3R)-2-hydroxy-3-[(3-hydroxy-2-methylbenzoyl) amino]-4-(phenylsulfanyl)butyl]...

Increased recognition needed for benefits of palliative care.(Recent Publications and Sources of Information)
June 22, 2004... There is strong evidence to suggest that palliative care, through the early identification and treatment of pain and other health problems, can make a dramatic difference in the quality of life of the dying and those who care for them....

Guidance for drug and therapeutics committees.(Recent Publications and Sources of Information)
June 22, 2004... Inefficient and irrational use of medicine is a widespread problem at all levels of the health care system and particularly in hospitals. Many sources of waste can be reduced through application of simple principles of drug management. A drug...

Use of traditional, complementary and alternative medicine.(Recent Publications and Sources of Information)
June 22, 2004... The use of traditional, complementary and alternative medicine continues to grow in line with the trend for patients to take a more proactive approach to their own health and seek out different forms of self care. However, in addition to the...

Antiretroviral treatment for women and infants: WHO guidelines.(Recent Publications and Sources of Information)
June 22, 2004... The latest WHO Guidelines on Care, Treatment and Support for Women Living with HIV/AIDS and their Children in Resource-Constrained Settings contain specific recommendations for the most frequently encountered clinical situations and may be of...

Malaria on-line project.(Recent Publications and Sources of Information)
June 22, 2004... A malaria educational website is provided by the Royal Perth Hospital, Australia, for clinicians, scientists, healthcare professionals and students. The site contains sections on malaria diagnosis, prophylaxis, treatment and history as well as...

Non-clinical safety testing: WHO handbook.(Recent Publications and Sources of Information)
June 22, 2004... WHO has released a handbook on nonclinical safety testing to serve as an aid for regulatory purposes during product development. A Scientific Working Group--composed of independent scientific specialists from around the world--was convened to...

Global Forum for Health Research: 10/90 Report.(Recent Publications and Sources of Information)
June 22, 2004... The Global Forum for Health Research has launched its fourth report on the state of world health research. The 10/90 Report on Health Research 2003-2004 reviews the recommendations made since 1990 to help correct the 10/90 gap and action taken...

UN consolidated list of products.(Recent Publications and Sources of Information)
June 22, 2004... The United Nations regularly publishes a consolidated list of chemical and pharmaceutical products whose consumption and/or sale have been banned, withdrawn, severely restricted or not approved by governments. It serves as a tool for...

Conflict of interest and research.(Recent Publications and Sources of Information)
June 22, 2004... The United States Office of Public Health and Science has announced publication of a guidance document on financial relationships and interests in research. The document raises points to consider in determining whether specific financial...

Access and use of psychotropic medicines.(Recent Publications and Sources of Information)
June 22, 2004... Mental and behavioural disorders account for a large proportion of the global burden of disease, but only a minority of those suffering from such disorders receive basic treatment and in many developing countries, health systems are often not...

Medical devices guidelines.(Recent Publications and Sources of Information)
June 22, 2004... A series of guidelines concerning medical devices has been developed to provide information on particular aspects of the new regulatory system for medical devices, which was introduced in Australia in October 2002. A medical device is...