Dr. Kim Mulvihill reportingThe Food and Drug Administration is making sweeping new changes for pain killers. It is yanking one drug off the market, dozens of others must carry new warning labels.
These moves caught many people off guard, as once again the FDA is going against the recommendation of its own advisory committee.
In February, after days of debate, an FDA advisory panel announced its recommendations on cox-two inhibitors.
"We all agree there's a risk from sustained cox 2."
The panel concluded Vioxx, Celebrex, and Bextra all pose heart risks but should be available to consumers.
Now the FDA is taking Bextra off the market. The reason? Besides the risk of heart attack and stroke, it carries a risk of serious, sometimes fatal skin reactions.
Even so, the news is disappointing to many, like Dr. Todd Schlifstein who says for some of his patients, Bextra is the only drug that works.
Dr. Todd Schlifstein, NYU Medical Center: "And they take the decisions out of the doctor's hands and won't allow you to use medications under your own supervision and guidance."
As for Celebrex, it can stay on the market but must carry the strongest safety warning possible on the label.
And it's not just the cox-two inhibitors. Those same warnings will now appear on all prescription nonsteroidal anti-inflammatory drugs. Dozens of over the counter pain relievers will be carrying new warnings as well. Brands like Advil, Aleve, and Motrin must alert consumers of increased heart risks, intestinal bleeding, and potential skin reactions.
The FDA says the goal is to maximize the benefits and minimize the risks of using any of these drugs.
Dr. Gerard Varlotta, NYU Medical Center: "That doesn't mean they can't sell them, that doesn't mean you can't use them, but you are now being advised that you have to use them appropriately."