Bextra withdrawn from market, strong warnings on popular painkillers

Apr 10 2005

The U.S. Food and Drug Administration (FDA) has issued warnings that most popular painkillers can hurt the heart, stomach and skin, and they have told pharmaceutical giant Pfizer to withdraw Bextra a top selling painkiller.

The labels for many prescription painkillers like Celebrex, Mobic, Naprosyn, Motrin, Voltaren and more than a dozen other drugs will soon carry explicit warnings about heart risks and even popular over-the-counter pills like Advil and Aleve will have to state risks to heart, stomach and skin on the product labels.

Recent results in studies done on Bextra and Celebrex, both from Pfizer, and Vioxx, made by Merck, have shown a strong implication that they increase the risks of heart attacks and strokes and suggests that older painkillers may act similarly, the FDA said it appears possible that all of the drugs in the class known as nonsteroidal anti-inflammatories cause similar problems.

Dr. Steven Galson, acting director of the FDA's centre for drugs says that they think these risks apply to all of these drugs and although there may be some differences, they have concluded that there is not enough data to rank the risks of the drugs. Galson emphasized that popular over-the-counter pain pills are safe if taken briefly and in low doses. Neither Tylenol nor aspirin are affected by the warnings.

Doctors need to be more careful in issuing prescriptions for those who have arthritis or are in chronic pain and must now ask about a patient's heart or stomach problems.