Pfizer announced that their newest cox-2 inhibitor drug, Bextra, is likely to have a "black box" warning added to it. This action comes after patients taking the drug experienced a serious skin reaction. The black box warning is the strongest a drug can have and still be on the market.
In the company's quarterly report, which was filed with the Securities and Exchange Commission, Pfizer said a few patients taking Bextra developed Stevens Johnson syndrome, which causes the immune system to turn itself on in order to get rid of the drug, and in effect, burning the patient from the inside out. The Stevens Johnson syndrome often involves severe blistering of the mucous membranes and skin, and has a 30 percent mortality rate.
Pfizer has stated that Bextra's label has included information about the risk of Stevens Johnson Syndrome since 2002, and in October of 2004 Pfizer sent a letter to doctors warning them about the risks of Stevens Johnson syndrome and saying that skin reactions have led to hospitalizations and deaths in a small number of patients. Pfizer also informed doctors that there appeared to be an increased risk of stroke and heart attack when Bextra was given to very high-risk patients who had undergone coronary bypass surgery. Pfizer plans to conduct long-term safety studies to determine whether Bextra affects heart attack and stroke rates in a less high-risk population.
