WHO Pharmaceuticals Newsletter 1999, No. 05&06
(1999; 20 pages)
Table des matières
Fermer ce répertoireRegulatory actions
Afficher le documentBromfenac: withdrawn: hepatotoxicity Saudi Arabia.
Afficher le documentCapecitabine and coumarin derivatives: revised data sheet: potential interaction Roche, United States of America.
Afficher le documentChlormezanone: withdrawn: cutaneous reactions Saudi Arabia.
Afficher le documentCyclandelate: withdrawn: ineffective Saudi Arabia.
Afficher le documentDipyridamole: withdrawn: United States of America.
Afficher le documentFenfluramine and dexfenfluramine: withdrawn: cardiotoxicity: Saudi Arabia.
Afficher le documentFlumazenil: revised data sheet: contraindications: Roche, United Kingdom.
Afficher le documentInfliximab: new prescribing information: Centocor, United States of America.
Afficher le documentMedicines Law: draft submitted to Parliament: Switzerland.
Afficher le documentMetamizole sodium: marketing authorization suspended: Sweden.
Afficher le documentParacetamol: revised labelling: warnings concerning overdosage: Sweden.
Afficher le documentPhenolphthalein in laxatives: withdrawn: risk of carcinogenicity: Saudi Arabia.
Afficher le documentTeicoplanin: revised data sheet: risk of superinfection: Hoechst Marion Roussel, United Kingdom.
Afficher le documentTerfenadine: withdrawn: cardiotoxicity: Saudi Arabia.
Afficher le documentTolcapone: withdrawn: hepatotoxicity: Australia.
Afficher le documentTriamcinolone hexacetonide: revised data sheet: use during pregnancy: United Kingdom.
Ouvrir ce répertoire et afficher son contenuDrug surveillance
Ouvrir ce répertoire et afficher son contenuNew developments
Ouvrir ce répertoire et afficher son contenuMedical devices
Ouvrir ce répertoire et afficher son contenuMedication errors
Ouvrir ce répertoire et afficher son contenuGeneral information
Ouvrir ce répertoire et afficher son contenuVeterinary 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Bromfenac: withdrawn: hepatotoxicity Saudi Arabia.

Further to the action taken by the Food and Drug Administration, the Ministry of Health has withdrawn from the market products containing bromfenac (Duract: Wyeth Ayerst) because of reports of liver failure, sometimes fatal.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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Dernière mise à jour: le 24 avril 2012