Bextra

Bextra®

Never discontinue taking any medications without first consulting your physician.

Bextra Withdrawn from the Market
On April 7, 2005, the Food and Drug Administration (FDA) asked Pfizer, Inc. to voluntarily withdraw Bextra from the marketplace. Bextra, a recent addition to the COX-2 class of drugs, was approved by the FDA in 2001 and was prescribed mainly as a pain reliever for sufferers of arthritis and other painful conditions. The FDA states that the overall risk versus benefit profile of the drug is unfavorable as Bextra is linked to several cardiovascular risks (heart attack and stroke), as well as serious and possibly life-threatening skin reactions including Stevens-Johnson Syndrome (1).

Ironically the move to pull Bextra from the market came only weeks after an FDA advisory panel narrowly voted to keep Bextra on the market despite long-term safety concerns.

What are COX-2 selective inhibitor drugs?
Bextra (valdecoxib), and Vioxx, a similar drug now withdrawn from the market, are members of a class of drugs called COX-2 selective inhibitors. They were developed as an alternative to traditional non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin and ibuprofen.

NSAIDs work by blocking the COX-2 enzyme in the body, which reduces swelling and associated pain; however, they also block the COX-1, which involves digestion in the gastrointestinal tract. This can cause serious GI side effects, including ulcers, burns and bleeding in the stomach lining. COX-2 selective inhibitors, however, block the inflammation-causing COX-2 enzyme only, an action that, theoretically, should preserve all of the NSAID benefits while eliminating the gastrointestinal side effects.

What dangers are associated with Bextra?
Controversy began when Pfizer, Inc. made an announcement on October 15, 2004, revealing information from two trials linking the use of Bextra in patients undergoing heart bypass surgery to an increase in cardiovascular events.

The concern continued after a presentation at the annual meeting of the American Heart Association in New Orleans in November 2004. At this meeting doctors presented the preliminary results of a study that used information from several Bextra trials to propose that the use of Bextra in high-risk cardiac patients more than doubled patient risk for heart attack and stroke. In the publication of their combined analysis of the two post-heart bypass surgery Bextra trials, they concluded that the use of Bextra was associated with a 3-fold higher risk of cardiovascular events than placebo (2).

Later that November at a congressional hearing, Dr. David Graham, an FDA Office of Drug Safety reviewer, named five drugs on the market whose safety needed serious reevaluation. One of the drugs on that list was Bextra, cited because of its cardiovascular and allergy risks and the availability of older, cheaper, equally effective, even safer, alternatives.

In December 2004 the FDA finally amended the Bextra label to include the new information regarding the use of the drug following open-heart surgery and the associated cardiovascular risks. The label listed the following cardiovascular risks that may be associated with Bextra use:

Heart attack
Stroke
Blood clots, including those in the legs (deep vein thrombosis) and lungs (pulmonary embolism)

At the same time, the FDA also strengthened the Bextra label warnings for risks of serious, sometimes fatal, skin reactions including Stevens-Johnson Syndrome (SJS). The symptoms of SJS often progress in severity as follows, especially if left untreated:

Flu-like symptoms, including fever, fatigue, headache, sore throat, cough, nausea, etc.
Blisters or rash of the skin
Blisters or lesions on the mucous membranes (thin moist tissues that line body cavities) of the mouth, nose, eyes, genitals, urinary tract, GI tract, respiratory tract
Ulceration of blisters leading to shedding of the skin

What actions are being taken to protect consumers?
On April 7, 2005, Pfizer, Inc. agreed to suspend sales of Bextra in the United States and Europe at the FDAs request. This decision came only weeks after an FDA advisory committee met and decided that Bextra and Celebrex (celecoxib), another COX-2 selective NSAID manufactured by Pfizer, Inc. could remain on the market and that Vioxx could potentially return.

In addition the FDA is asking the makers of all other prescription NSAIDs, including Celebrex, to include a strongly worded boxed warning about the cardiovascular and gastrointestinal risks associated with the drugs. The FDA has cautioned doctors in their prescribing of all COX-2 inhibitor drugs until more definitive safety information can be discovered.

Stricter warnings will now also appear on over-the-counter pain medicines, specifically drugs containing naproxen, ibuprofen, and ketoprofen because they too may cause cardiovascular and gastrointestinal risks in addition to adverse skin reactions.

What should I do if I am taking or have taken Bextra?
Never discontinue taking any medication without first consulting with your prescribing physician. However, if you or someone you know was taking Bextra and is concerned about the possible risks to their health, the FDA recommends you consult with a physician to discuss viable alternatives to this medication. If you or someone you know has experienced a serious cardiovascular event or adverse skin conditions while taking Bextra, we would like to help.

Sources:

1) FDA Announces Important Changes and Additional Warnings for COX-2 Selective and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), FDA Public Health Advisory, April 7, 2005.http://web.archive.org/web/20070708095400/http://www.fda.gov/

2) Parecoxib, Valdecoxib, and Cardiovascular Risk, Furberg et al, Circulation, 25 Jan 2005,http://web.archive.org/web/20070708095400/http://www.circulationaha.org/

* Never discontinue taking any medication without first consulting with your physician. This article is for informational purposes only. It is not intended to constitute medical advice and should not be viewed as such. For medical advice, you should always consult with your physician.

* Bextra and Celebrex are registered trademarks of Pfizer, Inc. and are used here only for the purpose of identifying the products in question.

* Vioxx is a registered trademark of Merck & Co., Inc. and is used here only for the purpose of identifying the product in question.

* This law firm is not affiliated with, sponsored by or associated with Pfizer Inc, Merck & Co., Inc., the FDA, or Circulation.

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