Bextra and the FDA

Bextra stroke, heart attack, and fatal skin condition risks were among the most serious side effects which prompted the Bextra recall. Bextra enjoyed about a three year stay on the market before being pulled from the shelves, yet knowledge of its serious side effects began surfacing soon after its 2001 FDA approval. As early as 2002, the FDA requested that Pfizer add stronger warnings to its Bextra labeling about serious skin side effects.