Lessons to learn from the COX-2 saga

Yes, FDA reforms are needed. And marketing distorts how medications are used. But one moral to the story is that all drugs have risks.

The bad news for the COX-2 pain relievers started in September 2004. Rofecoxib (Vioxx) was pulled from the market after a study testing whether the pain reliever could prevent colon polyps instead showed that it doubled heart attack and stroke risk.

In December 2004, it went from bad to worse. The FDA put its strongest "black box" warning on valdecoxib (Bextra), another COX-2 inhibitor. One study of celecoxib (Celebrex), the best seller in the class, showed that it, too, increased cardiovascular risk, although a smaller study gave it a clean bill of health. Pfizer kept Celebrex on the market, but the FDA forced the company to stop advertising it to the public.

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