FDA Warns on Pain Pill Use

It urges doctors and patients to weigh risk and reward after studies showing heart risks.
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Updated from 2:31 p.m. EST

The Food and Drug Administration Thursday issued a public health advisory urging doctors to weigh carefully the risks in prescribing certain drugs for arthritis and pain, and suggesting they limit the use of medications known as COX-2 inhibitors.

The agency also urged patients to pay strict attention to the labels of certain over-the-counter medications for pain relief.

The FDA, which said its recommendations are preliminary pending further review of clinical trial data, said it was acting in response to recent test results that indicated increased cardiovascular risks for

Pfizer's

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Celebrex and Bextra, and for naproxen. The latter is sold in nonprescription strength as Aleve and many generic brands and sold in prescription strength as Naprosyn.

Shares of Pfizer were up 15 cents, or 0.6%, to $26.10. Shares of

Merck

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were up 14 cents, or 0.4%, to $32.36. On Sept. 30, Merck removed Vioxx from the market because a test showed patients taking Vioxx for more than 18 months had a greater risk of heart attack and stroke than did patients taking a placebo.

Although Celebrex and Bextra are COX-2 inhibitors, as is Vioxx, Pfizer has said it will continue selling the drugs. There was no immediate comment from Pfizer or Merck on the FDA health advisory.

The FDA's action comes after several months of often contradictory test results that have confused patients, doctors, the companies that make the drugs and the companies' shareholders.

The agency added that an advisory committee has been convened for February to discuss all of the COX-2 drugs as well as NSAIDs, the group of drugs that includes naproxen, ibuprofen and aspirin. By then, the FDA said, it will have collected and analyzed "all available information" from the most recent studies of Vioxx, Celebrex, Bextra and naproxen.

Interim Recommendations

For physicians prescribing Celebrex or Bextra, the FDA said they should "consider this emerging information when weighing benefits against risks for individual patients."

The FDA said that patients at high risk for gastrointestinal bleeding have a history of "intolerance" to older painkillers known as nonsteroidal anti-inflammatory drugs, or NSAIDs. Doctors whose patients "are not doing well" on these drugs, the FDA said, "may be appropriate candidates for COX-2 inhibitor drugs such as Celebrex and Bextra."

The FDA told doctors to assess individual patients for their risk of cardiovascular problems "and other risks commonly associated with NSAIDs" when prescribing any arthritis drug and/or pain reliever.

And consumers should consult their doctors if they intend to take an over-the-counter NSAID for more than 10 days, the agency added.

In addition, the FDA said it is requiring an evaluation of all prevention studies that involve Celebrex and Bextra "to ensure that adequate precautions are implemented." A prevention trial is one in which healthy people are given medications to prevent a disease or condition such as colon polyps or Alzheimer's Disease.

The FDA said that although recent tests showing cardiovascular risk for Celebrex, Bextra and naproxen conflict with other results from other studies of the same drugs, the agency said it was best to act until these tests are studied in greater detail.

For example, one test released Friday showed patients taking Celebrex

had a higher risk of cardiovascular problems than did patients taking a placebo. But two other tests showed no increased risk of cardiovascular damage among Celebrex patients.

In addition, one recent test showed patients

taking a combination of Bextra and an experimental pain drug had a greater risk of heart problems compared to patients taking a placebo. This test examined patients who had undergone heart bypass surgery. Bextra is not permitted for any post-surgical care in the U.S.

However, another test of heart bypass surgery patients showed no statistically significant risk for cardiovascular problems among patients taking Bextra alone vs. patients receiving placebo. And in a third test involving general surgery patients, Bextra plus the experimental painkiller posed no additional risk.

On Monday, a clinical trial comparing patients

who took Celebrex or naproxen vs. patients taking a placebo demonstrated no cardiovascular risk for Celebrex but an increased risk for naproxen.