Monday, December 13, 2010

Drug Safety--Thelin (sitaxentan)

Pfizer recalls blood pressure drug due to liver damage.
The AP (12/10, Seaman) reported, "Pfizer Inc. said Friday it is pulling its blood pressure drug Thelin (sitaxsentan) off the market and stopping all clinical trials because the drug can cause fatal liver damage." Thelin "is sold in the European Union, Canada, and Australia as an oral treatment for severe pulmonary arterial hypertension, or high blood pressure in the pulmonary artery." Pfizer said "liver damage was a known side effect of Thelin and similar drugs...but the review uncovered a link to liver damage that was not tied to identifiable risk factors." In addition to the recall, the company "has withdrawn its filing for marketing in the United States."
According to the New York Times (12/10, Wilson) "Prescriptions" blog, Pfizer is halting "clinical trials it was conducting in a years-long quest to gain approval in the United States." The Food and Drug Administration "has rejected applications to market the drug in the United States at least three times in recent years, out of concern that the risks outweighed the drug's effectiveness -- concerns apparently validated by Pfizer's announcement."

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