Pfizer To Add ‘Black Box’ Warning to Bextra Label for Potential Skin Reaction
Pfizer officials on Friday announced that the company likely will add a "black box" warning to the label of its COX-2 inhibitor Bextra, after a few patients taking the drug -- which is similar to Merck's recently withdrawn Vioxx -- experienced a serious skin reaction, the AP/Long Island Newsday reports. A black box warning is the strongest a drug can carry.
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 "tur[n] on itself to rid itself of a drug, in effect burning the patient from the inside out," the AP/Newsday reports.
Stevens Johnson Syndrome often involves severe blistering of the mucous membranes and skin, according to Stevens Johnson Syndrome Foundation founder Jean Farrell-McCawley. Stevens Johnson has about a 30% mortality rate. According to the AP/Newsday, the risk of developing the syndrome is highest during the first two weeks a patient takes Bextra. Bextra's label has included information about the risk of Stevens Johnson Syndrome since 2002, according to Pfizer officials.
Pfizer in October 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.
Prudential analyst Timothy Anderson on Friday said he expects Bextra to have sales in 2005 of $1.7 billion, which would be a 15 cents a share increase to the company's bottom line next year. However, Anderson said he might lower his predictions as a result of the warning and a "signal" of cardiovascular toxicity. A member of Anderson's team owns shares of Pfizer, according to the AP/Newsday (AP/Long Island Newsday, 11/8).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.