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FDA Orders Broad Spectrum Review of Painkiller Drugs

Agency says it will look at studies of COX-2 and COX-1 inhibitors

THURSDAY, Dec. 23, 2004 (HealthDayNews) -- The U.S. Food and Drug Administration says it will review all prevention trials involving the prescription pain medications Celebrex and Bextra. These drugs are part of a category of drugs known as Cox-2 inhibitors.

The FDA also is going to examine data from the pain reliever naproxen -- which can also be bought over the counter -- to see whether it should fall under agency regulation.

And based on its statement issued Thursday, the agency also may be taking a look at the long-term effects of naproxen (Aleve) and other over-the-counter pain relievers Americans have been using for decades -- acetaminophen (Tylenol) and ibuprofen (Advil, Motrin).

According to the statement, the FDA's analysis will include "all available information from the most recent studies of Vioxx, Celebrex, Bextra and naproxen, and other data for COX-2 selective and nonselective NSAID products to determine whether additional regulatory action is needed."

An FDA official explained that the agency would be reviewing all studies involving COX-2 and COX-1 inhibitors. COX-1 inhibitors include most of the pain relievers bought without a prescription -- ibuprofen, acetaminophen, naproxen and aspirin.

"Consumers are advised that all over-the-counter pain medications ... should be used in strict accordance with the label directions," the Associated Press quoted Dr. John K. Jenkins, FDA director of new drugs, as saying at a news conference.

The agency also issued a public health advisory concerning the use of all nonsteroidal anti-inflammatory drugs (NSAIDs), the class of drugs that includes COX-2 inhibitors but also includes pain-killing medications such as naproxen and ibuprofen.

These latest actions are a direct result of recent evidence that the COX-2 inhibitors Vioxx, Celebrex and Bextra as well as naproxen, an over-the-counter COX-1 inhibitor, may increase the risk of heart attack and stroke, especially at higher doses and when used over long periods of time. Merck, the pharmaceutical firm that makes Vioxx, pulled it off the market in September. Pfizer Inc. makes Celebrex and Bextra.

Although this information is preliminary and at times conflicts with prior studies, the safety of the entire class of NSAIDs has now been called into question.

An FDA advisory committee meeting to discuss these issues is planned for February 2005.

At the same time, the FDA has reiterated its recommendations to physicians and patients:

  • Physicians should consider the emerging information when prescribing Celebrex or Bextra, especially the possible increased risk of cardiovascular events and other risks.
  • Consumers using over-the-counter pain medications should follow instructions on the label carefully and, if they need the drug for more than 10 days, they should consult their physician.
  • Patients who have a high risk of gastrointestinal bleeding or who are not doing well on older, traditional NSAIDs may still be appropriate candidates for the newer COX-2 agents.

Dr. Stephen Lindsey, section head of rheumatology at the Ochsner Clinic Foundation in Baton Rouge, La., said he felt the information contained in the new advisories was not, in fact, new.

"The FDA is trying to cover its bases, but unfortunately, it just keeps people more confused," he said. The timing is also poor, he added, as many patients will not be able to get in touch with their physicians over the coming days during the holiday season.

The consumer advocacy group Public Citizen condemned the FDA for not banning both Celebrex and Bextra. In an official statement, the director of the organization's health research group, Dr. Sidney Wolfe, also stated that there is no "credible evidence" that Celebrex or Bextra is protective to the gastrointestinal tract.

More information

Find the advisory at the FDA.

SOURCES: Dec. 23, 2004, FDA statement; Dec. 23, 2004, Public Citizen statement; Associated Press; Stephen Lindsey, M.D., section head of rheumatology, Ochsner Clinic Foundation, Baton Rouge, La.
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