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Afficher le documentAlbumin (human) B batches withdrawn: increase in aluminium level: Austria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Afficher le documentChlormezanone - withdrawn: Zimbabwe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Afficher le documentMetamizole sodium - withdrawn due to agranulocytosis: Zimbabwe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Afficher le documentPsorigon cream & lotion - withdrawn: undeclared cortisone ingredients: Germany, USA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
 

Fenfluramine and dexfenfluramine - warning concerning adverse reactions: Chile

Chile. The Directorate of the Instituto de Salud Pública has stipulated that the labelling for products containing the anorectic agents fenfluramine or dexfenfluramine shall include the following warning with effect from 26 February 1998:

“This medicine must be administered under strict medical supervision because of the risk of damage to the cardiac valves and/or primary pulmonary hypertension.”

[See also Pharmaceuticals Newsletter Nos. 1&2, 3&4, 7&8, 1998 and 9&19, 1997]

Reference: Boletín Informativo sobre Medicamentos Vol.15, No.1, April 1998, Resolution No. 265 of 26 January 1998.

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Dernière mise à jour: le 3 mai 2013