FDA approach tough pill for critics
January 8, 2005 12:38

Back in the 1990s, after decades of taking a slow, skeptical approach to approving new medicines, the Food and Drug Administration responded to pressures from patient-advocacy groups, private industry... (Read this Vioxx Article)

The securities class action complaint alleges that defendants misrepresented and omitted material facts about the safety and marketability of Pfizer's Celebrex and Bextra products. In fact, on November 4, 2004, the Calgary Herald reported that, "Celebrex, which was touted as a safe alternative pain drug after Vioxx was pulled from the market, is suspected of causing at least 14 deaths and numerous heart and brain side effects." The New York Times (NYSE: NYT - news) also reported that a study revealed that ". . . incidents of heart attacks and strokes among patients given Pfizer's painkiller Bextra was more than double that of those given placebos. Then, prior to the stock market opening on December 17, 2004, Pfizer revealed that in a recent trial, "patients taking 400mg and 800mg of Celebrex daily had an approximately 2.5 fold increase in their risk of experiencing a major or not-fatal cardiovascular event compared with those patients taking placebos." According to the company's website, Pfizer voluntarily pulled its Celebrex ads from all media after the safety of the product came under question.