Bextra Litigation at The Lanier Law Firm
Bextra (Valdecoxib) was approved by the FDA in 2001. Similar to VIOXX (Rofecoxib), Bextra is a Cox-2 inhibitor designed to treat and manage osteoarthritis, menstrual pain and acute pain in adults.
In the wake of Merck's withdrawal of Vioxx in September 2004, questions arose about whether similar Cox-2 inhibitors, such as Bextra, were linked to cardiovascular injuries. As a result, in February, 2005, the FDA asked an advisory committee to examine Cox-2 inhibitors and to determine whether the drugs offer enough benefits to stay on the market. Additionally, the FDA inquired whether Cox-2 inhibitors needed stronger warnings and what further research was needed on the drugs.
The advisory committee met February 16-18, 2005. During the hearings, Dr. Ned Braunstein, senior director of Merck Research Laboratories, told the FDA panel that studies "strongly suggested" that the entire class of drugs called Cox-2 inhibitors elevated the chances of cardiovascular problems. Dr. Garret Fitzgerald, a top scientist and Cox-2 researcher at the University of Pennsylvania, also told the U.S. regulatory panel that all pain drugs in the class known as Cox-2 inhibitors create an imbalance in the body's cardiovascular system that leads to an increased risk of heart attacks and strokes.
The hearings concluded and Bextra was allowed to remain on the market. However, on April 7, 2005, at the behest of the FDA, it was withdrawn from the U.S. market by its manufacturer, Pfizer Inc. The FDA stated that the risks posed by Bextra outweighed its benefits. These risks include a higher rate of cardiovascular injuries, such as heart attacks and strokes. Bextra has also been associated with serious skin reactions, such as Stevens Johnson Syndrome (SJS), an extreme allergic reaction commonly caused by drugs including Arava (leflunomide), painkillers, and sulfa antibiotics.
If you or a loved one has taken Bextra and suffered any side effects, please contact our office for a free evaluation.
Bextra Information Links:
2002 Bextra Dear Doctor Warning Letter (regarding Serious Skin Reactions)
