FDA Warns of Heart Risk For Pfizer's BextraDec 9, 2004 | AFX
The U.S. Food and Drug Administration said on Thursday that Pfizer's new pain drug Bextra will carry a labeled warning about a risk of cardiac and blood-clotting.
However, the agency said that, based on what it knows now, the therapy's benefits still appear to outweigh its risks when used properly.
Pfizer's drug is approved to treat the symptoms of osteoarthritis and rheumatoid arthritis, and menstrual pain.
Last month, study results presented at an American Heart Association meeting in New Orleans showed that patients taking Bextra had double the risk of heart attack and stroke compared with those taking placebo.