Pfizer, Inc., maker of the COX-2 inhibitor Bextra, said on December 9, 2004 that it would warn doctors that Bextra is linked to an elevated risk of blood clots, stroke and heart attacks in patients facing cardiac surgery. The FDA released an October study of 1500 cardiac-surgery patients in which it was found that those patients treated with Bextra were more likely to have heart attacks, blood clots and strokes than those who did not take the drug.

Pfizer has also placed a “black box” warning on Bextra. A “black box” warning is considered the strongest safety alert given to a drug on the market in the U.S. The warnings are intended for doctors considering prescribing the medication.

This “Black-Box” warning was due to the risk of a potentially fatal skin disease known as Stevens-Johnson Syndrome. Stevens-Johnson Syndrome, in effect, causes one’s immune system to turn on itself to fight off the drug, in effect burning the patient from the inside out. Sufferers of Stevens-Johnson Syndrome develop severe blisters on their skin and mucous membranes. Symptoms usually begin as a blistering of the lips and mouth that spreads to the throat, tongue, and other parts of the body. The blisters sometimes become so extensive that they are fatal.