WHO Pharmaceuticals Newsletter 1998, No. 09&10
(1998; 23 pages)
Table des matières
Fermer ce répertoireRegulatory decisions
Afficher le documentAlbumin (human) B batches withdrawn: increase in aluminium level: Austria
Afficher le documentAstemizole - warning concerning arrhythmias: Brazil
Afficher le documentChlormezanone - withdrawn: Zimbabwe
Afficher le documentChlorzoxazone - warning: hepatotoxicity: Chile
Afficher le documentCidofovir - adverse reactions: nephrotoxicity, uveitis/iritis and hearing loss: Gilead Sciences, USA
Afficher le documentFenfluramine and dexfenfluramine - temporary suspension: Brazil
Afficher le documentFenfluramine and dexfenfluramine - warning concerning adverse reactions: Chile
Afficher le documentIonic contrast media - notice of withdrawal: Germany
Afficher le documentLaxatives containing aloe, bisacodyl, cascara sagrada and senna - proposed reclassification: USA
Afficher le documentMeloxicam - data sheet revised: gastrointestinal and skin reactions: UK
Afficher le documentMetamizole sodium - withdrawn due to agranulocytosis: Zimbabwe
Afficher le documentMibefradil - suspended: Germany
Afficher le documentNifedipine - re-approved in myocardial infarction: New Zealand
Afficher le documentPsorial ointment - sales prohibited: undeclared cortisone ingredients: Sweden
Afficher le documentPsorigon cream & lotion - withdrawn: undeclared cortisone ingredients: Germany, USA
Afficher le documentTiclopidine - revised data sheet: thrombotic thrombocytopenic purpura: Roche, USA
Afficher le documentTroglitazone - revised instructions for use: Parke-Davis, USA
Afficher le documentVitamin A and betacarotene - labelling claim prohibited: USA
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 contenuGeneral information
Ouvrir ce répertoire et afficher son contenuMedication errors
Ouvrir ce répertoire et afficher son contenuVeterinary medicine
 

Ticlopidine - revised data sheet: thrombotic thrombocytopenic purpura: Roche, USA

Roche, United States of America. Following the publication of the results of a review reporting 60 cases of thrombotic thrombocytopenic purpura associated with the use of the platelet aggregation inhibitor, ticlopidine (Ticlid), the manufacturer has revised the package insert to include a boxed warning about this reaction and the relevant sections of the product information have been revised accordingly.

[See Pharmaceuticals Newsletter Nos. 5&6, May & June 1998; Nos 9&10, September & October 1997 and No. 2, February 1996]

Reference: “Dear Doctor” letter, Roche Laboratories Inc. [http://www.fda.gov/medwatch/safety/1998/ticlid2.htm]

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Dernière mise à jour: le 3 mai 2013