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Pfizer withdraws Thelin

Pfizer is voluntarily withdrawing Thelin for the treatment of pulmonary arterial hypertension in the EU, Canada and Australia

Pfizer has announced that it is voluntarily withdrawing Thelin (sitaxentan) for the treatment of pulmonary arterial hypertension (PAH) in regions where it is approved (the EU, Canada and Australia). In addition, Pfizer is discontinuing clinical studies of Thelin worldwide. The company said that the decision was in the interest of patient safety.

Pfizer's decision follows a review of emerging safety information from clinical trials and post-marketing reports. While liver toxicity is a known complication of the class of drugs to which Thelin belongs, a new potentially life-threatening idiosyncratic risk of liver injury with Thelin has been observed.

Given the availability of alternate treatments, Pfizer has concluded that the overall benefit of Thelin no longer outweighs the risk in the general population of PAH patients.

"Pfizer's priority is to ensure the safety and wellbeing of patients, and we are in the process of communicating all of this information to the appropriate medical professionals and regulatory authorities in all regions as quickly as possible," said Dr Cara Cassino, vice president, clinical development and medical affairs for Pfizer's Pulmonary Vascular Disease unit.

Pfizer recommends that no new patients be prescribed Thelin and that patients receiving Thelin be transitioned to appropriate alternate therapies as soon as safely possible, according to best local practice. Patients taking Thelin or participating in Thelin studies are advised to consult with their healthcare professional as soon as possible. Patients should not stop taking Thelin until they speak to their healthcare professional.

13th December 2010

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