Bextra Lawsuits
By Aaron Larson
March, 2005
Contents
What is Bextra
Bextra (Valdecoxib), produced by Pfizer, Inc., is a nonsteroidal anti-inflammatory drug (NSAID) used to treat osteoarthritis, adult rheumatoid arthritis, and painful menstruation.
Factual Background
In some patients, the use of NSAID's is associated with serious problems from stomach ulcers, including bleeding, and with liver damage. Concerns were raised about Bextra following the recall of Vioxx from the market. Bextra is also a COX-2 NSAID.
Bextra is alleged to have two possible areas of concern:
Heart Disease - In December 2004, in response to the results of a study of heart attacks and blood clots in heart bypass surgery patients, the FDA required Pfizer to provide a warning disclosing that risk to its users. Based upon recent studies, some consumer advocates suggest that Bextra poses a risk of heart attack similar to, and possibly greater than, that posed by other COX-2 inhibitors.
Allergic Reaction - It is alleged that Bextra can cause severe allergic reactions in some patients, including toxic epidermal necrolysis, and erythema multiforme, and Stevens Johnson Syndrome. Stevens Johnson Syndrome (SJS) involves severe and extremely painful blistering of the mucous membranes, sometimes associated with a rash or skin lesions. Toxic epidermal necrolysis (TEN) is a form of SJS, and involves similar blistering which causes the patient's skin to peel off in sheets. SJS and TEN create serious risk to the patient, similar in nature to a severe burn, including risk of infection and loss of fluids. Erythema multiforme (EM) involves a serious inflammatory skin rash.
Bextra Litigation
A number of law firms are recruiting clients for potential product liability litigation involving Bextra. While Pfizer has continued to insist that Bextra is safe, on April 7, 2005 Pfizer announced its withdrawal of Bextra from the market following an FDA determination that its risks outweighed its benefits.