WHO Pharmaceuticals Newsletter 1999, No. 05&06: Regulatory actions: Terfenadine: withdrawn: cardiotoxicity: Saudi Arabia.

WHO Pharmaceuticals Newsletter 1999, No. 05&06
(1999; 20 pages)

Table of Contents

	Regulatory actions
		Bromfenac: withdrawn: hepatotoxicity Saudi Arabia.
		Capecitabine and coumarin derivatives: revised data sheet: potential interaction Roche, United States of America.
		Chlormezanone: withdrawn: cutaneous reactions Saudi Arabia.
		Cyclandelate: withdrawn: ineffective Saudi Arabia.
		Dipyridamole: withdrawn: United States of America.
		Fenfluramine and dexfenfluramine: withdrawn: cardiotoxicity: Saudi Arabia.
		Flumazenil: revised data sheet: contraindications: Roche, United Kingdom.
		Infliximab: new prescribing information: Centocor, United States of America.
		Medicines Law: draft submitted to Parliament: Switzerland.
		Metamizole sodium: marketing authorization suspended: Sweden.
		Paracetamol: revised labelling: warnings concerning overdosage: Sweden.
		Phenolphthalein in laxatives: withdrawn: risk of carcinogenicity: Saudi Arabia.
		Teicoplanin: revised data sheet: risk of superinfection: Hoechst Marion Roussel, United Kingdom.
		Terfenadine: withdrawn: cardiotoxicity: Saudi Arabia.
		Tolcapone: withdrawn: hepatotoxicity: Australia.
		Triamcinolone hexacetonide: revised data sheet: use during pregnancy: United Kingdom.
	Drug surveillance
		Angiotensin II receptor antagonists losartan and irbesartan: review of adverse reactions: Australia.
		Asian remedy for menstrual cramps (“Koo Sar Pills”): lead poisoning in an adult reported: United States of America.
		Azathioprine and allopurinol: interaction: Australia.
		Echinacea: allergic reactions: Australia.
		Vigabatrin: visual field defects: update: Australia.
	New developments
		Amprenavir: approved for HIV-1 infection: United States of America.
		Orlistat: approved for obesity: United States of America.
		New indications
		New formulations
		Newly approved products
	Medical devices
		Blood clot removal device: approved: United States of America.
		Breast imaging device: approved: United States of America.
		Haemodialysis tubing set: defective device recalled: Althin Medical, United States of America.
		Hepatitis-C virus: first OTC home test approved: United States of America.
		Temporomandibular joint prostheses: premarket approval required: United States of America.
	Medication errors
		Communications problems: delay in recognition of medication errors: United States of America.
		Confusing directions: fatal overdosage: United States of America.
		Medication error prevention: strategies: United States of America.
		Similar packaging: potential for mistaken identity: United States of America.
		Visual cues: clues to medication errors: United States of America.
	General information
		Product name placement, size and prominence in advertising: guidance available: United States of America.
		Skin irritation and sensitization testing of generic transdermal drug products: draft guidance available: United States of America.
	Veterinary medicine
		Bacitracin methylene disalicylate soluble: approved for prevention and control of necrotic enteritis: United States of America.
		Eprinomectin: approved for treatment of parasites in cattle: Switzerland.
		Microbial effects of antimicrobial new animal drugs: assuring human safety: United States of America.

Terfenadine: withdrawn: cardiotoxicity: Saudi Arabia.

The Ministry of Health has withdrawn from the market products containing the histamine H1-receptor antagonist, terfenadine, because of reports of a potentially fatal heart condition associated with its use.

[See also Pharmaceuticals Newsletter Nos. 3&4, March & April 1998]

Reference: Communication from the WHO Regional Office for the Eastern Mediterranean enclosing a notification from the Ministry of Health, Saudi Arabia, 20 June 1999.