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Celebrex, Bextra Face FDA Scrutiny This Week

FDA Practices May Also Face Debate, Official Says
WebMD Health News

Feb. 16, 2005 - The fate of a highly controversial class of painkillers is likely to be decided at a federal inquiry scheduled to open today.

In three days of hearings set to begin today, the FDA and a panel of outside experts will investigate the safety of arthritis drugs called Cox-2 inhibitors. This group includes Vioxx, Celebrex, and Bextra.

FDA documents show that the hearings will focus on evidence that the drugs increase the risk of heart attacks and stroke, a finding that pushed Vioxx's manufacturer to pull it from the market in September 2004. This has also led many experts to call for a broad re-evaluation of the other Cox-2 inhibitors.

One consumer watchdog group has called for a ban on the two other available Cox-2 drugs because they have also been linked to an increased risk of heart problems. Others urge a less drastic approach, noting that the drugs are useful to elderly patients and others with arthritis pain because they may cause fewer of the side effects seen with older painkillers like ibuprofen.

"Everything is on the table as far as I'm concerned. But something is obviously going to need to be done," says one member of the FDA advisory panel who spoke on condition of anonymity.

The evidence is scheduled for review before a joint panel of members from the agency's arthritis and drug safety advisory committees. Experts will review a number of trials suggesting that, like Vioxx, other drugs in its class can increase the risk of dangerous heart problems by up to three or four times.

Data on Celebrex are mixed.

The National Institutes of Health suddenly halted one Celebrex trial in December 2004 when researchers noticed that patients taking 400 mg of the drug per day had a 3.4 times higher risk of a heart attack or stroke compared with patients who took a placebo. But they were taking twice the normal dose of 200 mg a day.

The study led Celebrex's manufacturer, Pfizer Inc., to halt all advertising promoting the drug.

Another NIH-backed trial showed no increased heart risk in 8,000 patients who took Celebrex. But the study was still halted because officials said it showed that the widely available drug Aleve, also called naproxen, raised the risk of heart problems in patients.

The decision of officials to halt the study remains controversial amid criticism that evidence of Aleve's adverse effects was weak.

In response to the Aleve results, John H. Klippel, MD, president of the Arthritis Foundation, told WebMD in December, "We are talking about a drug that has been around for 30 years and used by millions of people, and we are not aware that this issue has been raised elsewhere. So we don't believe this should have any immediate impact on the clinical use of this drug."

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