WHO Pharmaceuticals Newsletter 2003, No. 03: REGULATORY MATTERS: ASTEMIZOLE - Withdrawn due to life-threatening ventricular arrhythmias

WHO Pharmaceuticals Newsletter 2003, No. 03
(2003; 14 pages)

Índice de contenido

	REGULATORY MATTERS
		ACETYLSALICYLIC ACID - MHRA confirms labelling change
		ACITRETIN - Warnings of depression added to label
		ASTEMIZOLE - Withdrawn due to life-threatening ventricular arrhythmias
		CAMELIA SINENSIS - Ethanolic extract products withdrawn due to hepatotoxicity
		DIETARY SUPPLEMENTS - Withdrawal of two products due to presence of sildenafil
		HUA FO - Presence of tadalafil
		IODINE - Some products contain more than the RDA
		LEVODOPA/CARBIDOPA - New warning about somnolence and sudden onset sleep
		LINDANE - Additional warnings and medication guide added to label
		NEFAZODONE - Regulatory status update
		NIMESULIDE - Paediatric preparations banned in Bangladesh
		PERGOLIDE MESYLATE - Risk of cardiac valvulopathy
		REPAGLINIDE - Contraindicated with gemfibrozil
		RISPERIDONE - Prescribing information updated to reflect cardiovascular adverse events
		TELITHROMYCIN - Aggravation of myasthenia gravis
	SAFETY OF MEDICINES
		ANTIRETRO-VIRALS - Benefit/Risk balance remains strongly positive for combination antiretroviral therapy
		CYPROTERONE ACETATE & ETHINYL-ESTRADIOL - Update on risk of venous thromboembolism
		DIETHYL-STILBESTROL - Gynaecological and obstetric complications after in utero exposure
		EPHEDRA - Moves to reduce risks of ephedra-containing products
		FLUTICASONE PROPIONATE - Reports of adrenal crisis
		GRAPEFRUIT JUICE - Revised advice from ADRAC
		HORMONE REPLACEMENT THERAPY (HRT) - Risk of dementia
		OMEPRAZOLE, RABEPRAZOLE - Reports of interstitial nephritis
		ROFECOXIB, CELECOXIB - Case reports support causal association with liver toxicity
		ROSIGLITA-ZONE, PIOGLITAZONE - Adverse reactions update
		SOMATROPIN - Not to be authorized for AIDS-related wasting syndrome
	CURRENT CONCERNS
		Counterfeit Artesunate Antimalarial Tablets
	DRUGS OF INTEREST
		Haematologic toxicity of two glycopeptides: vancomycin and teicoplanin
	FEATURE
		WHO Training Workshop on Pharmacovigilance: Basic Introduction and Specifics for Malaria Programmes

ASTEMIZOLE - Withdrawn due to life-threatening ventricular arrhythmias

Spain. The Spanish Medicines Agency has withdrawn the marketing authorization for 10 medicinal products containing astemizole due to the potential of these products to produce life-threatening ventricular arrhythmias.

Reference:
Communication from the Spanish Medicines Agency, 8 Apr 2003. Available from URL: http://www.msc.es/agemed/csmh/notas/astemizol.asp