WHO Pharmaceuticals Newsletter 1997, No. 11&12
(1997; 24 pages)

Índice de contenido

	Regulatory actions
		Acetylsalicylic acid and paracetamol - prescription control: United Kingdom
		Chlormezanone - marketing authorization withdrawn: Germany
		Counterfeit antimalarial detected: Kenya
		Diphenhydramine - warning statements: United States of America
		Geriatric use - added to labelling: United States of America
		Herbal “Fen-Phen” - warning concerning “natural” anti-obesity alternatives: United States of America
		HIV protease inhibitors - hyperglycaemia: United Kingdom
		Irinotecan - revised data sheet: warning & precautions for use: Japan
		Lamotrigine - warning: severe cutaneous reactions: Australia
		Laxatives containing phenolphthalein - recommendation to revoke marketing authorization: Germany
		Levothyroxine sodium - new drug applications to be submitted: United States of America
		Lysine amidotrizoate in ionic contrast media - withdrawn: Germany
		Melatonin - prescription control: New Zealand
		Metamizole sodium - prohibited: Nepal
		NSAIDs, including acetylsalicylic acid - proposed risk-based framework: New Zealand
		Paediatric data - labelling to be required for new drugs: United States of America
		Paracetamol - restrictive measures: Ireland
		Pemoline - withdrawn: hepatotoxicity: United Kingdom
		Sodium hydrogen bicarbonate (paediatric) - prohibited: Nepal
		Suxamethonium chloride - warnings: cardiac arrest and hyperkalaemia: United States of America
		Terfenadine - restrictive measures: Ireland
		Terfenadine and terfenadine/pseudoephedrine - warnings concerning interactions: United States of America
		Tramadol - not recommended as first choice for moderate pain: Norway
		Tramadol - rescheduled: Oman
		Trihexyphenidyl - rescheduled: Oman
		Vigabatrin - visual field defects: Australia
		Women in clinical trials - proposed rule: United States of America
		Zafirlukast - possible association with Churg-Strauss syndrome: United States of America
	Drug surveillance
		Alendronic acid - oesophagitis: Australia
		Benzodiazepines in pregnancy and lactation - reminder: to be avoided: United Kingdom
		Drug-induced gynaecomastia - review of reports: Australia
		Ginkgo biloba - spontaneous haemorrhage: New Zealand
		Hydroxyamfetamine/tropicamide (Paremyd^R) - adverse reactions: United States of America
		Methotrexate (low-dose) - blood dyscrasias and other adverse reactions: United Kingdom
		Pethidine - convulsions: Australia
		Pyrithyldione/diphenhydramine - agranulocytosis: Spain
		Therapeutic switches - evaluation of risks: call for data: United States of America
	New developments
		Anagrelide - approved in essential thrombocythaemia: United States of America
		Thalidomide - interim approval for use in leprosy: United States of America
		Recent approvals
	Medical devices
		CFC-containing metered dose inhalers (MDIs) - still available for patients with asthma or COPD: United States of America
		CFCs - decision concerning use: revision: Switzerland
		Excimer laser systems - legal action taken against unapproved devices: United States of America
		Group B streptococcal antigen test kits - potentially fatal misdiagnoses: United States of America
		Home-use test kits - warning: United States of America
		Incontinence product - implanted device approved: United States of America
		Knee cartilage repair - accelerated approval of autologous cell therapy: United States of America
		Latex-containing devices - labelling required: United States of America
		Medical devices - software validation: guidance available: United States of America
		Temporomandibular joint prostheses - premarket approval to be required: United States of America
	General information
		Broadcast advertisements - draft guidance document available: United States of America
		Computerized systems used in clinical trials - draft guidance document available: United States of America
		Donors of human tissue for transplantation - guidance for screening and testing available: United States of America
		Medication errors - guidelines for injectable benzodiazepines: United States of America
	Veterinary medicine
		Chlortetracycline and tetracycline in veterinary medicines - revised package inserts: Germany
		Eprinomectin - approved for parasite control in cattle: United States of America
		Pharmacovigilance of veterinary medicines - draft guidelines: EC

WHO Pharmaceuticals Newsletter 1997, No. 11&12

WHO.INT

World Health Organization

Essential Drugs and Medicines Policy