WHO Drug Information articles from January 2001

WHO Drug Information archives from January 2001

Good pharmaceutical trade and distribution practices.
January 1, 2001... Over the past sixty years, there have been over 500 reported cases of fatal incidents due to the accidental but also fraudulent incorporation of diethylene glycol into pharmaceuticals [1]. About 80 children died in Haiti in 1996 as a result of...

Risk assessment as an element of drug control.
January 1, 2001... The responsibility of governments to establish systems which assure that all pharmaceutical products used in a given country are both safe and effective is now generally accepted, even if the extent of such responsibility may differ between...

The WHO Model List of Essential Drugs: latest developments.
January 1, 2001... The WHO Model List of Essential Drugs has been successful in establishing and promoting the concept of essential drugs. For more than twenty years, it has served as the gold standard for countries wishing to develop their own lists and has been...

Sequencing of the Anopheles gambiae genome.
January 1, 2001... Representatives of an international network of Anopheles gambiae researchers and genome sequencing centres met at the Pasteur Institute in Paris in March 2001 and agreed on the general principles and method of operation for sequencing the...

Multilateral Initiative on Malaria: benefits to the global community.
January 1, 2001... Malaria is responsible for enormous disease and economic burdens in malaria-endemic regions. A high percentage of those who die of malaria are African children under the age of five. Unfortunately, cases of malaria are on the rise due to...

China revises its pharmaceutical law.
January 1, 2001... The Chinese National People's Congress adopted a new pharmaceutical law on 28 February 2001 aiming to standardize China's pharmaceutical drug procurement and distribution system, to further encourage open market competitiveness in the...

New formulation of DTP vaccine.
January 1, 2001... United States of America -- The Food and Drug Administration (FDA) has approved a new, preservative-free formulation for a diphtheria and tetanus toxoid and acellular pertussis (DTaP) vaccine (Tripedia[R]). The reformulated product contains...

Bupropion safety reminder.
January 1, 2001... United Kingdom -- Bupropion (Zyban[R]) was licensed in June 2000 as an aid to smoking cessation in combination with motivational support in nicotine-dependent individuals aged 18 years or over. The initial dose is 150 mg twice daily. The...

Propofol: reactions to long-term high doses.
January 1, 2001... United Kingdom -- Propofol (Diprivan[R]) is a short-acting intravenous anaesthetic also used for sedation of ventilated adults receiving intensive care. A recently published study [1] suggests an association between long-term high-dose...

Propofol: not for paediatric use.
January 1, 2001... United States -- The manufacturer of propofol (Diprivan[R]) has informed Health Care Providers of the safety concerns of propofol injectable emulsion if used for sedation of intensive care paediatric patients. Propofol is currently not...

Leflunomide: hepatic reactions.
January 1, 2001... European Union -- The Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicines (EMEA) has evaluated reports of serious liver injuries, including hepatitis, hepatic failure and rare cases of...

Rapacuronium bromide voluntarily withdrawn.
January 1, 2001... United States of America -- The injectable drug rapacuronium bromide (Raplon[R]) is being voluntarily withdrawn from the market following reports, five of which were fatal, that the drug may by associated with bronchospasm. Rapacuronium...

Levacetylmethadol withdrawn.
January 1, 2001... European Union -- The European Agency for the Evaluation of Medicinal Products (EMEA) has issued a public statement regarding the suspension of the marketing authorization for levacetylmethadol (Orlaam[R]), a long-acting opiate used for the...

Levacetylmethadol: labelling changes.
January 1, 2001... United States of America -- The Food and Drug Administration (FDA) is strengthening warnings to physicians about serious cardiac adverse events associated with levacetylmethadol (Orlaam[R]), a drug for opiate addiction treatment. In...

Isotretinoin and depression.
January 1, 2001... Canada -- An increasing number of reports suggest a temporal association between isotretinoin (Accutane[R]) and depression and/or suicidal ideation in young people. As a result, additional information is being provided to patients and the...

New glucose test for adult diabetics.
January 1, 2001... United States of America -- The Food and Drug Administration has approved a wristwatch-like device that provides adult diabetics with more information for managing their disease. It is intended for use along with, not as a replacement for,...

Anti-inflammatory analgesics: hepatic reactions.
January 1, 2001... Finland -- Liver damage caused by anti-inflammatory analgesics is very rare and the incidence of symptomatic liver damage is estimated to be less than 0.05%. However, a symptom-free, mild increase in hepatic enzymes is more common and may occur...

Gentamicin ear drops: ototoxicity.
January 1, 2001... Canada -- The Canadian Adverse Drug Reaction Monitoring Program (CADRMP) warns that aminoglycoside ear drops can cause ototoxicity when used in patients with tympanic membrane perforation. Between 1981 and October 2000, the CADRMP received...

Tetracycline and benign intracranial hypertension.
January 1, 2001... New Zealand -- Benign intracranial hypertension (BIH) is a rare but potentially serious condition. BIH has been documented in association with a variety of medications, particularly the tetracyclines. The New Zealand Centre for Adverse...

Ergotamine and erythromycin interaction.
January 1, 2001... Australia -- Ergotism is manifested by symptoms and signs of peripheral ischaemia due to constriction of vascular smooth muscle caused by direct action of an ergot derivative. Headache, intermittent claudication, muscle pain, numbness, coldness...

Celecoxib and warfarin interaction.
January 1, 2001... Australia -- Since the introduction of celecoxib (Celebrex[R]) onto the market in October 1999, the Australian Adverse Drug Reactions Committee (ADRAC) has received 2218 reports of suspected adverse drug reactions. Of these, 21 cases describe...

Cerivastatin: rare effect of rhabdomyolysis.
January 1, 2001... Australia -- Cerivastatin (Lipobay[R]) is the fifth of the HMG-CoA reductase inhibitors (statins) to be marketed in Australia. Rhabdomyolysis is a known but rare effect of the statins and is more likely to occur when a fibrate is taken...

SSRIs and increased ocular pressure.
January 1, 2001... Australia -- From November 1972 to January 2001, the Australian Adverse Drug Reactions Committee (ADRAC) had received 92 reports of raised ocular pressure. Since 1992, there have been 11 reports implicating selective serotonin reuptake...

Amfepramone: new cases of primary pulmonary hypertension.
January 1, 2001... Belgium -- The Belgian Centre for Pharmacovigilance has recently been informed by a university hospital of the diagnosis of 9 cases of primary pulmonary hypertension (PPH) associated with previous use of amfepra-mone (diethylpropion) with or...

Bufexamac and contact eczema.
January 1, 2001... Germany -- The Drug Commission of the German Medical Profession has issued a cautionary statement concerning bufexamac, an anti-inflammatory agent used mainly for topical use. Initially, bufexamac was indicated for the relief of skin...

Droperidol: prolongation of the QT interval.
January 1, 2001... United Kingdom -- The Medicines Control Agency (MCA) has issued a safety notice concerning droperidol (Droleptan[R]) informing health professionals of the decision of the manufacturer to discontinue medicinal products containing droperidol from...

Mofezolac: revised data sheet.
January 1, 2001... Japan -- Mofezolac (Disopain[R]) was approved in July 1994 as a nonsteroidal anti-inflammatory analgesic agent which inhibits prostaglandin synthesis. The data sheet has now been revised to include gastrointestinal haemorrhage, abnormal...

Monoethanolamine oleate: revised data sheet.
January 1, 2001... Japan -- Monoethanolamine oleate (Oldamin[R] Injection) was approved in June 1996 for haemostasis in oesophageal varices, haemorrhage and sclerosis in oesophageal varices. The contraindications have recently been extended to include...

Rivastigmine: revised product information.
January 1, 2001... United States of America -- The manufacturer of rivastigmine (Exelon[R]), indicated for Alzheimer disease has informed health professionals of recent changes to the prescribing information. These changes provide guidelines for reinitiating...

Sarpogrelate: revised data sheet.
January 1, 2001... Japan -- Sarpogrelate was approved in July 1993 (Anplag[R]) and March 1999 and is indicated as a platelet aggregation inhibitor to improve peripheral circulation in the treatment of ischaemic symptoms observed in chronic arterial obstruction....

ATC/DDD methodology: a country perspective.
January 1, 2001... Ly Rootslane, Department of Pharmacy, Tartu University, Estonia Alar Irs, Department of Clinical Pharmacology, Tartu University, Estonia An interest in drug utilization in both scientific and governmental circles has developed as a...

International Nonproprietary Names for Pharmaceutical Substances (INN).
January 1, 2001... RECOMMENDED International Nonproprietary Names (Rec. INN): List 45 Notice is hereby given that, in accordance with paragraph 7 of the Procedure for the Selection of Recommended International Nonproprietary Names for Pharmaceutical...