As of August 10, the regulator had received eight reports of serious liver-related adverse reactions to the drug, including two deaths and two liver transplants, said Dr. Rohan Hammett, the agency's principal medical adviser, in a statement.
Prexige belongs to a class of drugs known as Cox-2 inhibitors.
These drugs were designed to be easier on the stomach than older pain pills such as ibuprofen and naproxen, which are associated with gastric bleeding in some patients. But several of the Cox-2 drugs became mired in safety issues in recent years.
The safety issues surround the pill in its 200mg form; there are no safety issues known to be associated with the 100mg pill, which has not been affected by the ruling.
