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FDA issues advisory for Celebrex, Bextra

Fri., Dec. 24, 2004

WASHINGTON – Federal regulators on Thursday ordered reviews of dozens of ongoing patient studies of the prescription painkillers Celebrex and Bextra in light of recent findings that both drugs may increase the risk of heart attack and stroke.

The Food and Drug Administration also issued an advisory urging consumers to follow the instructions on over-the-counter anti-inflammatory pain medications such as naproxen, ibuprofen and aspirin, whose labels limit their use to 10 days without a doctor’s approval.

The advisory also urges physicians to be highly selective in writing prescriptions for Celebrex and Bextra. Patients at risk of stomach bleeding, as well as those with a history of intolerance or who haven’t shown progress with other pain medications, “may be appropriate candidates” for (Celebrex and Bextra), said Dr. John K. Jenkins, the director of the FDA’s Office of New Drugs.

The new advisory “may well mean that (doctors) decide to use other agents instead of (Celebrex and Bextra) until we can sort out more clearly what the conflicting data show,” Jenkins said.

In conjunction with local trial review boards, the FDA will review the studies of healthy people who are given these medications in experiments intended to determine whether they can help prevent diseases such as colon polyps, which are sometimes a cancer precursor.

Celebrex and Bextra, both made by Pfizer, belong to a class of drugs known as Cox-2 inhibitors, which manufacturers say reduces the likelihood of gastrointestinal bleeding compared to traditional painkillers.

While some trials have indicated that Celebrex and Bextra, the only Cox-2 inhibitors still on the market, are less likely to cause gastrointestinal bleeding, other – but not all – trials have found that they can cause heart problems.

Merck pulled a third Cox-2 inhibitor, Vioxx, from the market recently after its users in a clinical trial showed markedly elevated risks of heart attack and stroke. At the same time, Merck stopped its patient studies using Vioxx.

Dr. Sidney Wolfe of Public Citizen Inc. and other consumer safety advocates have criticized the FDA for failing to act on studies that linked Cox-2 drugs and heart problems.

Jenkins said the FDA may take other actions on Cox-2 inhibitors, and even on naproxen, the active ingredient in non-prescription painkillers such as Aleve, which one study has linked to heart problems.

“The data from the controlled clinical trials is coming out fairly rapidly and we have not had an opportunity to fully evaluate all of the information. … We think we need to take time to do a careful review so that we can make appropriate regulatory decisions,” Jenkins said.

No further action is expected until after an FDA advisory committee meeting in February on Cox-2 inhibitors.


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