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news.Pfizer is voluntarily withdrawing Thelin (sitaxentan) for the treatment of pulmonary arterial hypertension (PAH) as the drug was found to be associated with risk of liver injury.
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Thelin will be withdrawn in regions where it is approved – the European Union, Canada and Australia, and the clinical studies of the drug will also be discontinued worldwide.
According to Pfizer, the decision was made following a review of emerging safety information from clinical trials and post-marketing reports, which revealed that Thelin was associated with the risk of liver injury.
The company has notified the health authorities about the risk and its decision to voluntary withdraw Thelin from the market and stop clinical studies.
In addition, Pfizer is recommending that no new patients be prescribed Thelin and those who are receiving Thelin should be transitioned to alternate therapies as soon as safely possible.