Bextra Litigation

Bextra (Valdecoxib) is a nonsteroidal anti-inflammatory drug (NSAID) produced by Pfizer, Inc. Bextra is prescribed for treatment of adult rheumatoid arthritis, osteoarthritis, and painful menstruation.

Some patients who take NSAIDs experience significant side-effects, including stomach ulcers, bleeding ulcers, and liver damage.

Subsequent to the recall of Vioxx from the market, concerns were raised about Bextra. Bextra, like Vioxx, is a COX-2 NSAID, and many felt that the same cost and safety issues presented by Vioxx were as significant for patients taking Bextra.

Two primary areas of concern were raised for patients who take Bextra:

  1. Allergic Reaction - Bextra is alleged to cause severe allergic reactions in some patients, including toxic epidermal necrolysis (TEN), erythema multiforme (EM), and Stevens Johnson Syndrome (SJS).>

    • Stevens Johnson Syndrome (SJS) results in extremely painful and severe blistering of the mucous membranes, which may be associated with skin lesions or a rash.

    • Toxic Epidermal Necrolysis (TEN) is a form of SJS. TEN involves similar severe blistering which causes the patient's skin to peel off in sheets. The effect of the blistering caused by SJS and TEN is similar in nature to a severe burn, and carries similar risk of both loss of fluids and infection.

    • Erythema Multiforme (EM) involves a serious, inflammatory skin rash.

  2. Heart Disease: Following the results of a study of blood clotting and heart attacks in coronary bypass surgery patients, in December, 2004 the FDA required Pfizer to warn patients of heart disease associated with the use of Bextra. Some consumer advocates believe that the risk of heart attack posed by Bextra is similar to, and may in fact be greater than, the risk posed by other COX-2 inhibitors.

A number of law firms actively recruited clients in anticipation of product liability lawsuits involving Bextra.

On April 7, 2005, following a determination by the FDA that the risks of Bextra use exceed its benefits, Pfizer announced that it was withdrawing of Bextra from the market.

On September 2, 2009, following a guilty plea by one of its subsidiaries for marketing medications, including Bextra, with the intent to mislead Pfizer agreed to pay a $2.3 billion dollar fine to settle a case brought by the U.S. Department of Justice. The subsidiary, Pharmacia & Upjohn, admitted to criminal conduct in its promotion of Bextra and agreed to pay a criminal fine of $1.195 billion.

Copyright © 2004 Aaron Larson, All rights reserved. No portion of this article may be reproduced without the express written permission of the copyright holder. If you use a quotation, excerpt or paraphrase of this article, except as otherwise authorized in writing by the author of the article you must cite this article as a source for your work and include a link back to the original article from any online materials that incorporate or are derived from the content of this article.

This article was last reviewed or amended on May 7, 2018.