Did the Food and Drug Administration (FDA) know about these allergic reactions?
Yes. The FDA announced on November 15, 2002, that it had received about 20 reports of serious reactions, including skin diseases [Stevens Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), exfoliative dermatitis, and erythema mutliforme (EM)] and hypersensitivity reactions (anaphylactic reactions and angioedema). Pharmacia had issued a "Dear Healthcare Professional" letter two days earlier. Previously, on October 22, the European Medicines Evaluation Agency (the European counterpart to the FDA) issued a public statement warning of the same side effects due to taking Bextra. Unfortunately, all this came too late for Bextra patients who have been suffering from the serious and potentially fatal drug allergic reactions like Stevens Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and erythema multiforme (EM).
The information on this page is meant to provide a general overview of the law. The laws in your state and/or city may deviate significantly from those described here. If you have specific questions related to your situation you should speak with a local attorney.
Additional Bextra Articles
- What is Bextra?
- What is the COX enzyme?
- What are NSAIDs?
- Is Bextra right for me?
- What is the problem with Bextra?
- What should I tell my health care provider?
- What is toxic epidermal necrolysis?
- What is Stevens Johnson Syndrome?
- What is exfoliative dermatitis?
- What is erythema multiforme?