(Photos8.com)
Pfizer Inc. in New York, New York said today (10 December) that it is voluntarily withdrawing its drug Thelin (sitaxentan) for the treatment of pulmonary arterial hypertension (PAH) in the European Union, Canada, and Australia, where the drug was approved. In addition, Pfizer is discontinuing clinical studies of Thelin worldwide.
PAH is abnormally high blood pressure in the arteries of the lungs. It makes the right side of the heart need to work harder than normal.
The company says it made the decision in the interest of patient safety, based on a review of new information from clinical trials and post-marketing reports. Pfizer says it was aware of complications of liver toxicity in the class of drugs to which Thelin belongs, but a new potentially life-threatening idiosyncratic risk of liver injury with Thelin has been observed.
Pfizer concluded that the overall benefit of Thelin no longer outweighs the risk in the general population of PAH patients, particularly with the availability of alternate treatments. The company says it has notified health authorities about the decision to voluntarily withdraw Thelin from the market and stop clinical studies.
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