Reuters Health Information (2010-12-10): Pfizer pulls Thelin (sitaxsentan sodium) off market due to liver injury
Pfizer pulls Thelin (sitaxsentan sodium) off market due to liver injury
Last Updated: 2010-12-10 11:20:04 -0400 (Reuters Health)
BOSTON (Reuters) - Pfizer Inc said on Friday it is halting clinical trials of Thelin (sitaxsentan sodium) to treat pulmonary arterial hypertension and withdrawing it from markets where it has been approved, after it was found to be associated with potentially life-threatening liver toxicity.
Pfizer said it has concluded that the risks of the drug outweigh the overall benefit for patients with PAH.
Thelin generated sales of $44.4 million in the first nine months of 2010.
The company is withdrawing the drug from regions in which it is already approved - the European Union, Canada and Australia. Thelin competes with Tracleer (bosentan), a drug made by Actelion Ltd. and with Letairis (ambrisentan), a drug made by Gilead Sciences.