WHO Drug Information articles from January 1999

WHO Drug Information archives from January 1999

General Policy Issues.
January 1, 1999... WHO roundtable with the research-based pharmaceutical industry On 21 October1998, Dr Gro Harlem Brundtland, the newly elected Director-General of WHO, met with key figures of the research-based pharmaceutical industry to explore ways in...

Personal Perspectives.
January 1, 1999... International harmonization of safety information: a CIOMS initiative Faculty of Health Sciences Copenhagen, Denmark and member of CIOMS Working Group The Council for International Organizations of Medical Sciences (CIOMS) was...

Short-course zidovudine in perinatal HIV transmission.
January 1, 1999... In 1994, a reduction of 67.5% in the relative risk of mother-to-child transmission of HIV was demonstrated in newborn infants treated before, during and after birth with zidovudine [1]. Further data from a recent trial in Thailand suggest that...

Vitamin D supplements in adults.
January 1, 1999... Vitamin D is an essential precursor of 1,25-dihydroxyvitamin D, the steroid hormone necessary not only for bone development and growth in children but maintenance of bone in adults. In particular, vitamin D deficiency is a risk factor for bone...

Tacrine and Alzheimer disease.
January 1, 1999... The present ageing of the worlds population will lead to an increase in cases of elderly dementia, of which Alzheimer disease is a common form. The possibilities for prevention of Alzheimer are limited by the major determinants -- age and...

Anti-ulcer drugs may mask early gastric cancer.
January 1, 1999... Dyspepsia, typically presenting as heartburn or gastrointestinal discomfort, is responsible for about 2-5% of patient visits to general health care physicians. In over 50% of cases, no firm diagnosis is possible because symptoms are of an...

WHO develops artesunate for emergency treatment of malaria.
January 1, 1999... Artesunate Task Force, World Health Organization, Geneva Traditionally, the development of new drugs relies to a great extent on the ability of the pharmaceutical industry to carry out scientific and technological research on behalf of...

Vitamin A supplementation strategies.
January 1, 1999... Vitamin A deficiency has been identified as a problem of public health importance in over 118 countries worldwide and about 250 million children are estimated to be at risk of this deficiency. Among children under 5 years of age, some 3 million...

The microbial threat: Copenhagen recommendations.
January 1, 1999... The increasing resistance of microorganisms to antimicrobial agents is a major public health problem in Europe. The international spread of microorganisms means that this can no longer be regarded as a national, but an international problem and...

The International Pharmacopoeia: 50 years on.
January 1, 1999... In countries with a robust pharmaceutical market, regulatory control measures ensure that drugs are efficacious, safe and of good quality. However, the extent to which a national health authority is able to provide adequate regulatory control...

Artemisinin: guidelines for use.
January 1, 1999... Artemisinin products were first developed as antimalarials in China. They resolve fever and clear parasites more rapidly than any other known antimalarial agent. Moreover, they are the only group of antimalarial drugs to which Plasmodium...

Tolcapone and fatal liver injury.
January 1, 1999... European Union -- The European Agency for the Evaluation of Medicines (EMEA) has issued a recommendation to suspend the marketing authorization for tolcapone, a catechol-O-methyl transferase (COMT) inhibitor indicated as adjunctive treatment...

Entacapone labelling strengthened.
January 1, 1999... European Union -- The European Agency for the Evaluation of Medicines (EMEA) has requested reinforced patient information from the manufacturer of entacapone, a COMT inhibitor which was approved in September 1998 for Parkinson disease [1, 2],...

Rituximab: new recommendations.
January 1, 1999... European Union -- The European Agency for the Evaluation of Medicines (EMEA) has received reports of severe adverse reactions, including 8 fatal cases of cytokine release syndrome, associated with the monoclonal antibody, rituximab. The product...

Montelukast and eosinophilia.
January 1, 1999... United States of America - Montelukast is a selective leukotriene (LTD4) receptor antagonist that was approved by the Food and Drug Administration in February 1998 for the prophylaxis and chronic treatment of asthma in adults and children over...

Amineptine and dependence.
January 1, 1999... France - In collaboration with the manufacturer, the Medicines Agency has decided to suspend the marketing authorization of amineptine following reports of drug abuse and dependence. Amineptine is an antidepressant which inhibits the...

Cosmetic contains pharmaceutical substances.
January 1, 1999... Germany - The Federal Institute for Drugs and Medical Devices has withdrawn a range of skin products, Psorigon(r), from the market after formulations were found to contain unlabelled cortisone derivatives and tretinoin. Neither of these...

Jurisdiction over cloning technology.
January 1, 1999... United States of America -- The Food and Drug Administration has issued a letter to all institutional review boards (IRBs) confirming that the agency has jurisdiction over clinical research involving human cloning technology and informing IRBs...

Contaminated hydrocortisone.
January 1, 1999... France/Belgium -- Following a request by the University Hospital of Kamenge, Burundi, the French Medicines Agency has analysed a 200 mg/20 ml preparation of injectable solution hydrocortisone manufactured in China by Shanghai Sine...

Intravenous immune globulin and acute renal failure.
January 1, 1999... United States of America -- The Center for Biologics Evaluation and Research of the Food and Drug Administration has circulated a warning to physicians concerning the potential risk of acute renal failure associated with the intravenous...

Sertindole suspended pending evaluation.
January 1, 1999... United Kingdom -- The Committee on Safety of Medicines has informed physicians that the manufacturer of sertindole, an antipsychotic agent indicated for the treatment of schizophrenia, has voluntarily suspended availability of the product...

Labelling information for paediatric use.
January 1, 1999... United States of America -- The Food and Drug Administration has issued a final rule requiring that applications for new drugs and biological products contain sufficient data and information to support directions for paediatric use. This action...

Tryptophan prescribing warning.
January 1, 1999... Sweden -- The Medical Products Agency has informed physicians that tryptophan is not authorized as a medical product and can be prescribed only in the context of clinical trials as a supplementary medication for sleeping disorders or...

Impurities in dietary tryptophan products.
January 1, 1999... United States of America -- The Food and Drug Administration has confirmed the presence of impurities in some 5-hydroxy-l-tryptophan (5HTP) products promoted for use as aids for insomnia, depression, obesity and for children with attention...

Chlormezanone withdrawn.
January 1, 1999... Zimbabwe -- The Medicines Control Authority has cancelled the marketing authorization for products containing chlormezanone following international regulatory action based on safety evaluations. The drug has been associated with an unacceptable...

New home screening test for abuse drugs.
January 1, 1999... United States of America -- The Food and Drug Administration has approved a nonprescription test for drugs of abuse that can be performed at home and gives preliminary results in minutes. However, conclusive results can only be provided by a...

High-dose terfenadine withdrawn.
January 1, 1999... European Union -- The Commission for Proprietary Medicinal Products (CPMP) has decided to withdraw 120 mg strength terfenadine products from the market because of a higher risk of overdose [1]. The labelling for lower dose products has also...

Liquid ecstasy (GHB) trading investigated.
January 1, 1999... United Kingdom -- The Medicines Control Agency is investigating the illegal trading and promotion of gamma hydroxybutyrate (GHB), a drug known as 'liquid ecstasy". The drug has been promoted for body building, with the claim that it stimulates...

Metamizole sodium withdrawn.
January 1, 1999... Zimbabwe -- The Medicines Control Agency has cancelled the marketing authorization for all pharmaceutical products containing metamizole sodium because of the potential risk of fatal agranulocytosis. Reference: Drug In formation Bulletin,...

Medication guides.
January 1, 1999... A Medication Guide will be required when: (1) the drug product is one for which further information could help prevent serious adverse effects; (ii) the drug product has serious risks and these risks could affect the patients decision to use or...

Streptokinase: severe back pain.
January 1, 1999... Sweden -- The Medical Products Agency has received reports of severe acute back pain in six patients treated with streptokinase infusion. The pain occurred when 10-15 ml of streptokinase had been given to patients requiring a further dose. ...

Sildenafil: revised labelling.
January 1, 1999... United States of America -- In collaboration with the manufacturer, the Food and Drug Administration is advising doctors of new warnings and information which have been added to the product labelling for sildenafil (Viagra(r)). Over 6...

Chlorzoxazone and hepatotoxicity.
January 1, 1999... Chile -- The product information and labelling for products containing chlorzoxazone, a muscle relaxant, have been revised to include a warning of severe hepatic damage. This is a rare, but unpredictable occurrence and will depend on the...

Mislabelling of glucose.
January 1, 1999... Belgium -- Two premature infants have died after being administered potassium chloride (KCI) taken from containers labelled glucose 5% 10-ml sterile solution for injection. The manufacturer and distributor reports that one batch, number 97H21C...

Internet sale of gamma butyrolactone (GBL).
January 1, 1999... United States of America -- Products containing gamma butyrolactone (GBL) are being sold via the internet, in health food stores, gymnasiums and fitness centres under various brand names such as Blue Nitro, or GH Revitalizer. These products,...

ATC/DDD Classification (temporary).
January 1, 1999... ATC/DDD Classification (temporary) ATC Level INN/common name New ATC level codes (other than 5th level) Selective estrogen receptor modulators COX-2 specific inhibitors New A TC...

ATC/DDD Classification (final).
January 1, 1999... ATC/DDD Classification (final) ATC Level INN/common name New ATC level codes (other than 5th level): Helicobacter pylori, combinations for eradication of Antipsoriatics, other, for...

Diuretics.
January 1, 1999... Diuretics are employed to increase urinary excretion in the treatment of hypertension and oedema due to congestive heart failure or chronic renal or hepatic disease. They reduce extracellular fluid volume by decreasing total body sodium...

AMILORIDE.
January 1, 1999... Tablet: 5 mg (hydrochloride) Uses: Oedema associated with heart failure and hepatic cirrhosis (with or without ascites). Also used in combination with thiazide or loop diuretics to conserve potassium. Dosage: 10 mg daily adjusted...

FUROSEMIDE.
January 1, 1999... Tablet: 40 mg Injection: 10 mg/ml in 2-ml ampoule Uses: Oedema due to congestive heart failure or renal or hepatic disease. Oliguria. Dosage: Oedema Adults: Initial oral dose of 40 mg daily on rising. Maintenance dose of 20...

HYDROCHLOROTHIAZIDE.
January 1, 1999... Tablet: 25 mg, 50 mg Uses: Oedema, mild to moderate hypertension. Dosage: Hypertension: 12.5--25 mg daily. Adults with oedema: Initial oral dose to be taken on rising of 25 mg daily. If necessary, increase to 50 mg daily. ...

MANNITOL.
January 1, 1999... Injectable solution: 10% and 20% Uses: To treat raised intracranial pressure, intracranial oedema, intraocular pressure and oedema in glaucoma, or for administration in preparation for intraocular surgery. Dosage: Reduction of...

SPIRONOLACTONE.
January 1, 1999... Tablet: 25 mg Uses: Refractory oedema in patients with congestive heart failure, nephrotic syndrome, hepatic cirrhosis (with or without ascites) and in ascites associated with malignancy. Diagnosis and treatment of primary...

The New Emergency Health Kit 98.
January 1, 1999... The provision of health care is difficult and demanding in the aftermath of large scale emergencies and disasters. In collaboration with a large number of international agencies, WHO has developed the emergency health kit which is available...

Tuberculosis and air travel.
January 1, 1999... In recent years, the potential for transmission of tuberculosis infection during air travel has been investigated. Although the risk of transmission has been documented, it seems to be relatively low. Nonetheless, within the next decade, it is...

Effects of antimicrobials used in food-producing animals.
January 1, 1999... The US Food and Drug Administration has recently issued A Proposed Framework for Evaluating and Assuring the Human Safety of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals. This is the second...

Quality control methods for medicinal plant materials.
January 1, 1999... Because of their increasing use worldwide, more and more attention is being paid to the quality of plant materials used in over-the-counter preparations, home remedies or as raw materials for pharmaceutical preparations. This book has been...

Basic tests for drugs.
January 1, 1999... Basic tests represent one of the many elements of quality assurance for pharmaceutical products. The basic test series has been developed by WHO to provide a simple method to confirm the identity of a substance or indicate whether gross...

Information data base for dietary supplements.
January 1, 1999... Currently, the term dietary supplement is used for a wide array of products available in health food stores, pharmacies or by mail order which contain vitamins, minerals, nutrients and herbals as well as ingredients and extracts of animal and...

International Nonproprietary Names for Pharmaceutical Substances (INN).
January 1, 1999... RECOMMENDED International Nonproprietary Names (Rec. INN): List 41 Notice is hereby given that, in accordance with paragraph 7 of the Procedure for the Selection of Recommended International Nonproprietary Names for Pharmaceutical...

Denominations communes internationales des Substances pharmaceutiques (DCI).
January 1, 1999... Denominations communes internationales RECOMMENDEES (DCI Rec): Liste 41 II est notifie que, conformement aux dispositions du paragraphe 7 dela Procedure a suivre en vue du choix de Denominations communes internationales recommandees...

Denominaciones Comunes Internacionales para las Sustancias Farmaceuticas (DCI).
January 1, 1999... Denominaciones Comunes Internacionales RECOMENDADAS (DCI Rec.): Lista 41 De conformidad con lo que dispone el parrafo 7 del Procedimiento de Selection de Denominaciones Comunes Internacionales Recomendadas para las Sustancias Farmaceuticas...