Danger of Bextra®
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The FDA determined in early April 2005 that the danger of Bextra® was great enough to elicit the recall of this top-selling prescription pain reliever. On April 7, 2005 Pfizer announced the Bextra® recall, stating that the danger of Bextra® side effects greatly outweighed this drug's intended benefits. Information about the danger of Bextra® has been mounting with exponential speed over the past few months, though the danger of Bextra® has been known for years.
Bextra® is a COX-2 selective non-steroidal anti-inflammatory drug (NSAID) approved by the FDA in November 2001. Bextra®, and other prescription COX-2 selective NSAIDs like Vioxx and Celebrex, were developed in the late 1990s to treat the pain associated with arthritis, menstrual cramps, and other chronic pain conditions. These drugs were originally designed to effectively treat pain without causing the gastrointestinal side effects associated with traditional NSAIDs like naproxen and ibuprofen.
The danger of Bextra® use was discovered soon after this drug received FDA approval. Common side effects of Bextra® included gastrointestinal complications similar to those caused by traditional NSAIDs. Fatal adverse skin reactions were among the first serious side effects revealing the true danger of Bextra®. Bextra® users began to develop a deadly disease known as Stevens Johnson syndrome. This potentially fatal danger of Bextra® attacks the skin and mucous membranes, essentially burning the skin from the inside out, leading to death if not promptly and adequately treated.
Once this danger of Bextra® became known, the FDA requested that Pfizer add stronger warnings to Bextra® product information. In 2002 the FDA asked Pfizer to add a black box warning to all Bextra® product patient information to inform patients about the danger of Bextra®. A black box is the strongest warning the FDA can request, short of a drug recall. Despite government pressure, Pfizer failed to comply with this request and responsibly inform consumers about the danger of Bextra® use.
In 2004 more new about the danger of Bextra® was discovered. A Pfizer-sponsored clinical study was designed to evaluate the effects of Bextra® on pain management after heart surgery. Those participants taking Bextra® were twice as likely to suffer a stroke, heart attack, blood clot, or renal failure as compared to those in the control group. Despite this added danger of Bextra®, Pfizer still maintained that their product was safe enough to remain on the market.
Strong evidence to the contrary prompted the FDA to ask doctors to prescribe Bextra® only when necessary until the danger of Bextra® was further evaluated. After a few months of investigation, the FDA finally announced that the danger of Bextra® use was too great to allow this defective drug to remain on the market.
If you are concerned about the serious danger of Bextra® use, or have been injured by this prescription painkiller, please contact a Bextra® Recall Lawyer in your area.
