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HEALTH NEWS

Bextra Faces Nationwide Personal Injury Litigation

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Contributed by Ron Gara|  09 April, 2005  16:52 GMT

Bextra Pfizer withdrawal FDA arthritis drug
'We need to make sure that people who have taken Bextra or Celebrex and suffered a serious side effect are heard and that the drug manufacturer is held accountable. Pfizer failed to disclose the risks of Bextra and Celebrex, and many people have suffered strokes and heart attacks as a result. We want to help those who have been injured.'
Attorneys representing patients who claim to have suffered injury as a result of using Pfizer's arthritis painkiller Bextra on Friday asked a judicial panel in Washington, D.C., to move all the related lawsuits in the US to one federal court in New Orleans for consolidation and management. The action came in the wake of Pfizer's announcement on Thursday that it would suspend sales and marketing of Bextra.

Pfizer's voluntary withdrawal of Bextra from the market was in response to a request by the Food and Drug Administration (FDA).

The FDA issued a public health advisory regarding the action stating that patients taking Bextra should consult with their physicians about alternatives to the non-steroidal anti-inflammatory drug (NSAID). The risks posed by Bextra outweigh its benefits, the FDA said.

The FDA has concluded that Bextra can increase the risk of serious side effects, including heart attack and stroke, and can lead to a skin reaction that can be life-threatening and sometimes fatal.

Nationwide Litigation

Numerous Louisiana lawyers already have been heavily involved in lawsuits around the US involving Bextra and Celebrex, including Dawn M. Barrios of New Orleans, Vance R. Andrus of Lafayette, Matthew E. Lundy of Lake Charles, and Richard J. Arsenault of Alexandria. Bryan F. Aylstock, a lawyer in Gulf Breeze, Florida, is also involved in the lawsuits.

"We're all gearing up to possibly be at the center of this nationwide litigation," Arsenault stated. "All of the cases involving Vioxx have been transferred to the federal court in New Orleans and it would be appropriate if the Bextra/Celebrex litigation were here also."

Studies Contradict Claims

Pfizer has claimed that Bextra does not present the same heart-related risks as Vioxx. However, a recent study involving 12 clinical trials and 5,930 participants found that people who took Bextra were 2.19 times more likely to have a severe coronary event, such as a heart attack or stroke, than those who took a placebo. Dr. Garret FitzGerald, a cardiologist and pharmacologist at the University of Pennsylvania, presented the results of the study at the American Heart Association's annual conference in November 2004,

More recently, in February 2005, Pfizer acknowledged the existence of a 1999 study -- designed to examine whether Celebrex could treat Alzheimer's disease -- that found "the number of Celebrex patients suffering heart attacks was almost four times that of those taking a placebo." The study was never published and was not submitted to the FDA until several years later.

Echoes of Vioxx Controversy

"The withdrawal of Bextra is reminiscent of what happened with Vioxx back in September," Arsenault noted. "We need to make sure that people who have taken Bextra or Celebrex and suffered a serious side effect are heard and that the drug manufacturer is held accountable. Pfizer failed to disclose the risks of Bextra and Celebrex, and many people have suffered strokes and heart attacks as a result. We want to help those who have been injured."

At the same time that it requested the withdrawal of Bextra, the FDA also ordered that warning labels be added to Pfizer's Celebrex and 18 other NSAIDs. A black box warning is the strongest possible advisory notice that a medication can carry and still remain on the US market. The black box will warn people that long-term use may increase the risks of heart attacks and strokes.

Related Articles
Bextra Pulled as FDA Cracks Down on NSAIDs (7 Apr 2005)
FDA Requires Stronger Warning on Celebrex Label (2 Aug 2005)
Canadian Experts Give Vioxx Thumbs Up (8 Jul 2005)
FDA Orders Review of Painkiller Data, Issues Cox-2 Advisory (24 Dec 2004)
Celebrex Users Stunned, Confused, Worried (20 Dec 2004)
FDA Committees to Sort Out Pros and Cons of COX-2 Painkillers at Public Meeting (16 Jan 2005)
 
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