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Bextra: More Risks Than Benefits

Apr 8, 2005 |

The Food and Drug Administration has asked pharmaceutical company Pfizer to pull Bextra off the market because of evidence that it increases the risk of heart attacks, strokes and a potentially fatal skin condition as well.

The Early Show medical correspondent Dr. Emily Senay explains what this might mean to you.

Bextra falls into a class of painkillers known as Cox-2 inhibtors that are very popular among people with arthritis. They have been in the news a lot lately (since the fall, in fact) when one of them, Vioxx, was voluntarily pulled of the market because people who took it were found to be at an increased risk of heart attack and stroke.

The FDA now says that Bextra poses these same heart risks and, in addition, people taking the drug are at risk for a serious and sometimes fatal skin reaction.

So what should patients taking Bextra do?

Pfizer, which makes Bextra, suggests that anybody on the drug stop taking it and contact their physician about other treatment options.

The FDA now wants all the drugs in this class that are still on the market to carry what's known as a "black box warning," which states clearly that these Cox-2 inhibitors can increase your chances of cardiovascular problems.

Merck, which manufactures Vioxx, stands by the decision to voluntarily remove the drug from the market. However, the company maintains that Vioxx offers unique benefits among the Cox-2 class of drugs.

So how is it that Celebrex (another very popular Cox-2) is still on the market? In February, a panel that advises the FDA said that Celebrex seemed to have the fewest cardiovascular side effects of all the Cox-2 drugs. But, as mentioned earlier, the government now wants it to carry one of those black box warning labels.

Over-the counter pain relievers such as Advil and Aleve, still very popular with arthritis sufferers, are not Cox-2 inhibitors. But the FDA has asked the makers of these medications to revise their labels to say that people who take them are at an increased risk for heart attacks, stroke, gastrointestinal bleeding and serious skin reactions.

The FDA says the the warning labels which will be placed on the over-the counter pain relievers will not be placed on aspirin because it has "special benefits when taken in low doses."

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