WHO Pharmaceuticals Newsletter 1999, No. 05&06
(1999; 20 pages)
Table of Contents
Close this folderRegulatory actions
View the documentBromfenac: withdrawn: hepatotoxicity Saudi Arabia.
View the documentCapecitabine and coumarin derivatives: revised data sheet: potential interaction Roche, United States of America.
View the documentChlormezanone: withdrawn: cutaneous reactions Saudi Arabia.
View the documentCyclandelate: withdrawn: ineffective Saudi Arabia.
View the documentDipyridamole: withdrawn: United States of America.
View the documentFenfluramine and dexfenfluramine: withdrawn: cardiotoxicity: Saudi Arabia.
View the documentFlumazenil: revised data sheet: contraindications: Roche, United Kingdom.
View the documentInfliximab: new prescribing information: Centocor, United States of America.
View the documentMedicines Law: draft submitted to Parliament: Switzerland.
View the documentMetamizole sodium: marketing authorization suspended: Sweden.
View the documentParacetamol: revised labelling: warnings concerning overdosage: Sweden.
View the documentPhenolphthalein in laxatives: withdrawn: risk of carcinogenicity: Saudi Arabia.
View the documentTeicoplanin: revised data sheet: risk of superinfection: Hoechst Marion Roussel, United Kingdom.
View the documentTerfenadine: withdrawn: cardiotoxicity: Saudi Arabia.
View the documentTolcapone: withdrawn: hepatotoxicity: Australia.
View the documentTriamcinolone hexacetonide: revised data sheet: use during pregnancy: United Kingdom.
Open this folder and view contentsDrug surveillance
Open this folder and view contentsNew developments
Open this folder and view contentsMedical devices
Open this folder and view contentsMedication errors
Open this folder and view contentsGeneral information
Open this folder and view contentsVeterinary medicine
 

Bromfenac: withdrawn: hepatotoxicity Saudi Arabia.

Further to the action taken by the Food and Drug Administration, the Ministry of Health has withdrawn from the market products containing bromfenac (Duract: Wyeth Ayerst) because of reports of liver failure, sometimes fatal.

[See also Information Exchange System Alert No. 71, 26 June 1998]

References:

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

2) FDA Talk Paper T98-36 dated 22 June 1998.

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Last updated: May 3, 2013