WHO Pharmaceuticals Newsletter 1998, No. 09&10
(1998; 23 pages)

Table des matières

	Regulatory decisions
		Albumin (human) B batches withdrawn: increase in aluminium level: Austria
		Astemizole - warning concerning arrhythmias: Brazil
		Chlormezanone - withdrawn: Zimbabwe
		Chlorzoxazone - warning: hepatotoxicity: Chile
		Cidofovir - adverse reactions: nephrotoxicity, uveitis/iritis and hearing loss: Gilead Sciences, USA
		Fenfluramine and dexfenfluramine - temporary suspension: Brazil
		Fenfluramine and dexfenfluramine - warning concerning adverse reactions: Chile
		Ionic contrast media - notice of withdrawal: Germany
		Laxatives containing aloe, bisacodyl, cascara sagrada and senna - proposed reclassification: USA
		Meloxicam - data sheet revised: gastrointestinal and skin reactions: UK
		Metamizole sodium - withdrawn due to agranulocytosis: Zimbabwe
		Mibefradil - suspended: Germany
		Nifedipine - re-approved in myocardial infarction: New Zealand
		Psorial ointment - sales prohibited: undeclared cortisone ingredients: Sweden
		Psorigon cream & lotion - withdrawn: undeclared cortisone ingredients: Germany, USA
		Ticlopidine - revised data sheet: thrombotic thrombocytopenic purpura: Roche, USA
		Troglitazone - revised instructions for use: Parke-Davis, USA
		Vitamin A and betacarotene - labelling claim prohibited: USA
	Drug surveillance
		Albumin and plasma protein fraction - safety concerns: USA
		Alendronic acid - reminder: oesophageal reactions: UK
		Drug-induced amnesia - review: Australia
		Isotretinoin - depression: Australia
		Isotretinoin - adverse reaction profile: UK
		Leukotriene antagonists: montelukast & zafirlukast - safe use: UK
		Levonorgestrel - use for emergency contraception: WHO/HRP
		Selective serotonin reuptake inhibitors (SSRIs) - haemorrhage: Australia
		Sildenafil (Viagra) - summary of reports of death: update: USA
		Tryptophan, 5HTP and eosinophilia-myalgia syndrome - impurities confirmed: USA
	New developments
		Fomepizole - approved as an antidote in ethylene glycol poisoning: USA
		Infliximab - approved for Crohn’s disease: USA
		Leflunomide - oral treatment approved for active rheumatoid arthritis: USA
		Lepirudin - approved for heparin-associated thrombocytopenia: UK
		Oral contraceptives - approved for emergency use: USA
		Rotavirus vaccine - approved to help prevent rotaviral disease: USA
		Thalidomide - approved for use in leprosy: USA
		New indications
		New formulations
		Newly approved products
	Medical devices
		Blood glucose meters - recalled because of error readings: USA
		EpiPen epinephrine auto-injectors - recall of syringes: Switzerland
		Medical devices - the year 2000 problem: guidance document: USA
		Skin wound closure adhesive - approved: USA
		Weight loss device - recalled: USA
	General information
		Biotechnological/biological products - draft guidance available: USA
		Blood and blood components - draft guidance available: USA
		Nucleic acid sequence - in vitro tests - draft guidance available: USA
		Paediatric exclusivity - draft guidance available: USA
		Self-medication - medicines now available without prescription: Germany, France
		Topical dermatological drug products - draft guidance available: USA
		Vaccines and related products - draft guidance available: USA
	Medication errors
		Flomax and Fosamax - name confusion: USA
		Invirase and Fortovase (saquinavir) - confusion between two formulations: USA
		Lipid-based drug products - errors due to confusion with conventional products: USA
		Minimizing medical product errors - summary of workshop available: USA
		Neumega and Neupogen - name confusion: USA
		Nortriptyline - errors in dosage: USA
		Oxycodone - errors due to formulation confusion: USA
		Soriatane and Loxitane - prescribing errors due to name confusion: USA
	Veterinary medicine
		Clenbuterol-containing veterinary medicines - suspension of indication extended: Germany
		Ipronidazole in veterinary medicines - marketing authorization revoked: carcinogenicity: Germany
		Labelling of drugs for use in milk- producing animals - revised regulations: final rule: USA

WHO Pharmaceuticals Newsletter 1998, No. 09&10

Essential Drugs and Medicines Policy

WHO.INT

World Health Organization