FDA Panel Affirms Safety Of Painkiller Celebrex

Updated at 1:54 p.m.

A prescription painkiller that has been under a cloud for more than a decade is apparently safer than previously believed, a Food and Drug Administration panel concluded Wednesday.

The drug celecoxib, which is sold by Pfizer under the brand name Celebrex, poses no greater risk for causing heart attacks and strokes than two other widely used pain relievers, the committee voted at the end of a two-day hearing. The vote was 15-5. One member abstained.

Based on the committee's conclusion, the FDA may change the advice about the drug's safety that it provides to doctors. The FDA doesn't have to follow the advice of advisory committees advice but usually does.

The availability and safety of alternatives to opioid painkillers have become increasingly important as the nation grapples with the deadly epidemic.

For more than a decade, some doctors have been reluctant to prescribe celecoxib, which isn't an opioid, because it is similar to Vioxx, a pain reliever that was withdrawn from the market in 2004 because of safety concerns. Both drugs are known as COX-2 inhibitors because they act by blocking an enzyme involved in inflammation.

After Vioxx was launched in 1999, it quickly became a blockbuster and was used by millions of people. It was designed to cause fewer gastrointestinal complications than existing pain relievers. But Vioxx was pulled from the market in 2004 after being linked to heart attacks and strokes.

A similar drug, called Bextra, was pulled from the market in 2005. The FDA allowed Celebrex to remain on the market but ordered Pfizer to conduct a large study to examine the drug's safety. The medicine has since become available in generic forms.

The FDA's committee's conclusion is based on the results of that study, which involved more than 24,000 patients with osteoarthritis and rheumatoid arthritis. One-third took celecoxib, which is only available by prescription. One-third took prescription doses of ibuprofen. The remaining third took prescription naproxen.

The study found no evidence that celecoxib poses any greater risk for causing heart attacks and strokes than ibuprofen or naproxen. Those medications are in category known as nonsteroidal anti-inflammatory drugs, or NSAIDs.

Many of the committee members stressed that celecoxib isn't completely safe. The study showed it can increase the chance of cardiovascular complications. But celecoxib doesn't appear to boost those odds nearly as much as Vioxx did, or apparently even as much as prescription doses of ibuprofen and naproxen, which were thought to be safer.

The study found the risk of dying, suffering a stroke or having a heart attack among patients taking celecoxib was 2.3 percent during a 30-month period, compared with 2.5 percent for naproxen and 2.7 percent for ibuprofen

In fact, celecoxib was less likely to cause certain complications, such as gastrointestinal problems like ulcers and bleeding, as well as kidney problems such as kidney failure and the need for dialysis, according to the study. Some committee members questioned the significance of these findings, and the committee didn't take a specific vote on these results.

Ibuprofen is sold over the counter in much lower doses as a generic and under a variety of brand names, including Advil and Motrin. Naproxen, also generic, is sold over the counter with various names, like Aleve and Naprosyn.

The maximum recommended over-the-counter dose of ibuprofen is typically 1,200 milligrams daily. The study used 600 milligrams of ibuprofen three times a day, or 1,800 milligrams daily. Naproxen tablets are sold over the counter at a dose of 220 milligrams and are taken twice a day. The study used doses between 375 and 500 milligrams taken twice a day.

The committee considered whether nonprescription doses of ibuprofen and naproxen can interfere with the ability of low-dose aspirin to protect people against heart attacks. Millions of people take low doses of aspirin daily to reduce their risk of having a heart attack.

The committee voted 12-7, with one member abstaining, in favor or warning patients taking aspirin about the possible risk of taking naproxen at the same time. Ibuprofen also carries a warning like that, and the committee voted 17-4 against adding any additional warnings.

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