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Sitaxentan to be Withdrawn Due to Cases of Unpredictable Serious Liver Injury LONDON -- December 11, 2010 -- The European Medicines Agency has been informed of Pfizer’s decision to voluntarily withdraw sitaentan (Thelin) from the market worldwide further to new information on 2 cases of fatal liver injury. Pfizer has also decided to discontinue all ongoing clinical trials. Sitaxentan has been authorised in the EU since 2006 for the treatment of pulmonary arterial hypertension. Sitaxentan has been known to be associated with liver toxicity and since its initial marketing authorisation has been contra-indicated in patients with mild to severe hepatic impairment (Child-Pugh Class A-C) and elevated aminotransferases prior to initiation of treatment. At this stage, patients taking sitaxentan or participating in sitaxentan studies are advised not to stop treatment and to consult their treating physician to review their treatment at their next scheduled appointment. The Agency’s scientific Committee for Medicinal Products for Human Use (CHMP) will look at this issue during their plenary meeting December 13-16, 2010, and will provide detailed advice for patients and prescribers. SOURCE: European Medicines Agency E-mail this page to a friend or colleague! To print, use this version