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 May 12, 2005
Bextra Pulled From Market
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By E.J. Mundell, HealthDay Reporter

THURSDAY, April 7 (HealthDay News) -- The painkiller Bextra was pulled from U.S. and European markets Thursday following sweeping new U.S. Food and Drug Administration actions that mandate black-box warnings on all similar prescription drugs and labeling changes for similar over-the-counter drugs.

"We've asked Pfizer, and they've agreed, to stop selling Bextra," Dr. Stephen K. Galson, acting director of the FDA Center for Drug Evaluation and Research, told reporters at a teleconference Thursday.

He and other FDA officials cited heightened cardiovascular risks associated with long-term use of the drug, as well as incidents of a rare but potentially fatal skin reaction, as the primary reasons for pulling Bextra from the market.

"Secondly, we're asking all manufacturers of prescription NSAID drugs -- including what remains the only cox-2-specific drug on the market, Celebrex -- to include a boxed warning, our highest-level warning, on the label," Galson added.

He said the tough new labeling "highlights the major risk of these products, which are gastrointestinal bleeding and cardiovascular adverse events."

Besides Celebrex, which is being allowed to stay on pharmacy shelves pending further study, other popular, prescription non-steroidal anti-inflammatory drugs (NSAIDS) covered by the labeling order include prescription Aleve and prescription ibuprofen.

Galson said all prescription NSAIDS will also have to have special "Medication Guides" further outlining these risks, to be provided to consumers by pharmacists as they fill their prescriptions.

In addition, the FDA will require labeling changes for all over-the-counter NSAIDS, including popular brands such as Advil, Aleve, and Motrin and generic ibuprofen. These changes, while not as strongly worded as the black box warning, will alert consumers to possible cardiovascular and gastrointestinal risks associated with long-term use.

Aspirin is exempt from any warnings, officials added.

In a statement issued before the news conference, Galson said, "Today's actions protect and advance the health of millions of Americans who rely on these drugs everyday."

He said the agency is "providing the public information based on the latest available scientific data to guide the careful and appropriate use of these drugs aimed at maximizing their potential benefits and minimizing their risks."

Thursday's action appears, in part, to overrule an advisory panel's recommendations that all three cox-2s, Celebrex, Bextra and Vioxx, should stay on the market despite their known cardiovascular risks.

After a highly emotional set of public hearings in February, the panel of scientists and doctors found the heart risks were very real but appeared to determine that the drugs' benefits outweighed their risks.

Thursday's announcement is the death knell for Bextra, which FDA experts say has been linked to increased cardiovascular and gastrointestinal risks, as well as isolated and unpredictable incidents of a serious, life-threatening skin disease, Stephen Johnson syndrome, officials said.

Agency officials also said Bextra appears to offer patients no added therapeutic benefit that can't be found in other available medications.

As for blockbuster Celebrex, also made by Pfizer, agency officials concluded that the drug's benefits still outweigh any risks to patients. But the drug will carry the heightened black-box warning, and the special "Medication Guide" now mandated for all prescription NSAIDS.

The FDA is also asking that Pfizer "commit to conduct a long-term study of the safety of Celebrex compared to naproxen [Aleve] and other appropriate drugs."

A third cox-2 inhibitor, Merck Inc.'s Vioxx, was voluntarily withdrawn from the market in September of last year, after a major study linked long-term use with cardiovascular disease.

In the statement released Thursday, the FDA said the agency "will carefully review any proposal from Merck for resumption of marketing of Vioxx, and would likely discuss the review with the new FDA Drug Safety Oversight Board and an Advisory Committee before making a final decision."

More information

For more on Thursday's actions involving these painkilling drugs, visit the FDA (www.fda.gov ).

SOURCES: April 7, 2005, teleconference, Stephen K. Galson, acting director, U.S. Food and Drug Administration Center for Drug Evaluation and Research; FDA press statement

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