WHO Pharmaceuticals Newsletter 1998, No. 09&10
(1998; 23 pages)
Índice de contenido
Cerrar esta carpetaRegulatory decisions
Ver el documentoAlbumin (human) B batches withdrawn: increase in aluminium level: Austria
Ver el documentoAstemizole - warning concerning arrhythmias: Brazil
Ver el documentoChlormezanone - withdrawn: Zimbabwe
Ver el documentoChlorzoxazone - warning: hepatotoxicity: Chile
Ver el documentoCidofovir - adverse reactions: nephrotoxicity, uveitis/iritis and hearing loss: Gilead Sciences, USA
Ver el documentoFenfluramine and dexfenfluramine - temporary suspension: Brazil
Ver el documentoFenfluramine and dexfenfluramine - warning concerning adverse reactions: Chile
Ver el documentoIonic contrast media - notice of withdrawal: Germany
Ver el documentoLaxatives containing aloe, bisacodyl, cascara sagrada and senna - proposed reclassification: USA
Ver el documentoMeloxicam - data sheet revised: gastrointestinal and skin reactions: UK
Ver el documentoMetamizole sodium - withdrawn due to agranulocytosis: Zimbabwe
Ver el documentoMibefradil - suspended: Germany
Ver el documentoNifedipine - re-approved in myocardial infarction: New Zealand
Ver el documentoPsorial ointment - sales prohibited: undeclared cortisone ingredients: Sweden
Ver el documentoPsorigon cream & lotion - withdrawn: undeclared cortisone ingredients: Germany, USA
Ver el documentoTiclopidine - revised data sheet: thrombotic thrombocytopenic purpura: Roche, USA
Ver el documentoTroglitazone - revised instructions for use: Parke-Davis, USA
Ver el documentoVitamin A and betacarotene - labelling claim prohibited: USA
Abrir esta carpeta y ver su contenidoDrug surveillance
Abrir esta carpeta y ver su contenidoNew developments
Abrir esta carpeta y ver su contenidoMedical devices
Abrir esta carpeta y ver su contenidoGeneral information
Abrir esta carpeta y ver su contenidoMedication errors
Abrir esta carpeta y ver su contenidoVeterinary 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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Última actualización: le 3 mayo 2013