Pfizer Inc. will warn doctors that its Bextra painkiller, which is similar to Merck & Co.’s withdrawn Vioxx, is linked to an elevated risk of blood clots, heart attacks and strokes, U.S regulators said.
Pfizer, the world’s biggest drugmaker, also will strengthen existing warnings of a potentially fatal skin reaction to Bextra, the U.S. Food and Drug Administration said today in a posting on its Web site.
Bextra is one of five drugs that FDA reviewer David Graham identified as unsafe at a Nov. 18 Senate hearing. A study of more than 1,500 cardiac-surgery patients found that those treated with Bextra were more likely to have heart attacks, strokes and blood clots in their legs and lungs than those who didn’t take the drug, the FDA said.
“FDA will continue to monitor the side effects related to Bextra and take additional actions as appropriate,” the agency said in a statement.
Bextra is part of a class of painkillers that inhibit the body’s production of the Cox-2 enzyme, which is linked to pain and swelling. The group also includes Merck’s Vioxx, withdrawn Sept. 30 in the biggest drug recall ever after a company study showed patients taking it 18 months or longer had twice the risk of heart attacks and strokes as those taking a placebo.