Historical Archive

AIFA: CLOBUTINOL WITHDRAWN FROM THE WORLD MARKET

On August 31, the manufacturer of the medicinal specialty Silomat , in syrup and drops (containing the antitussive clobutinol), voluntarily withdrew the product from the world market for safety reasons. The decision to withdraw the drug was based on evidence of an increased risk of electrocardiogram QTc prolongation and possible impact on arrhythmias (Torsades de points), revealed by the preliminary results of a clinical study in healthy volunteers. Patients being treated with the drug must immediately suspend the therapy and contact their doctor for the prescription of a therapeutic alternative. AIFA Important Information Note, August 2007. NCF dated 04/12/2007 NOVEMBER 2007 p. 27  

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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco