FDA requests Pfizer withdraw Bextra

The Food and Drug Administration has asked Pfizer to voluntarily pull its painkiller Bextra off the market on April 7, 2005. A Health Advisory issued that day stated that: “FDA has concluded that the overall risk versus benefit profile is unfavorable…” The Advisory also listed requests for more specific labeling for all Non-steroidal Anti-inflammatory Drugs (NSAIDs) excluding aspirin. The most comprehensive labeling recommendations are for the remaining COX-2 selective NSAID on the market, Celebrex.

The FDA based their request for Bextra’s removal on three specific points:

· The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse CV events in short-term coronary artery bypass surgery (CABG) trials that FDA believes may be relevant to chronic use.

· Reports of serious and potentially life-threatening skin reactions, including deaths, in patients using Bextra. The risk of these reactions in individual patients is unpredictable, occurring in patients with and without a prior history of sulfa allergy, and after both short- and long-term use.

· Lack of any demonstrated advantages for Bextra compared with other NSAIDs.

The also stated that patients currently using Bextra should consult their doctors regarding an alternative painkiller.

The FDA decided that the benefits of Celebrex outweigh the potential risks, and has not requested that it be removed from the market. Both Celebrex and Bextra are manufactured by Pfizer Inc.

Merck removed its COX-2 painkiller Vioxx voluntarily in September 2004 after results in one of their own trials showed an increase in the risk of heart attack and other serious heart problems during use of the product.

The FDA Health Advisory also issued a warning about non-selective NSAIDs like Ibuprofen and Naproxen, stating that: “Long-term controlled clinical trials have not been conducted with most of these NSAIDs. However, the available data suggest that use of these drugs may increase CV risk.” The FDA requested label changes reflecting these risks, and requested that the manufacturers submit a comprehensive review of their product based on data already available from trials.

The Advisory made special note of prescription NSAIDs, specifically stating that the risk could be increased for those who recently underwent heart surgery. Over-the-counter NSAIDs will remain on the shelves because: “The available data do not suggest an increased risk of serious CV events for the short-term, low-dose use of the NSAIDs available over the counter. FDA will allow these products to remain on the market, but will request changes to the label to better inform consumers regarding the safe use of these products.”

If you have had skin rashes, heart problems, or other health problems while taking Bextra or other pain reliever, contact your doctor immediately. Then contact a Jim S. Adler & Associates personal injury lawyer. Recovery will take time and your medical bills could become high, all because of a drug that was found too dangerous to remain on the market. Don’t suffer financially through this hard time as well as physically. Contact Jim S. Adler & Associates for a free case review and find out what your rights are.

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