And Then There Was One
by Denise Mann
Arthritis Today, August 2005

Timeline of Trouble

1999: Celebrex and Vioxx on the market.

November 2000: Increased heart disease seen in the Vioxx Gastrointestinal Outcomes Research (ViGOR) trial.

April 2002: FDA requires Merck to alert public about possible increased risk of heart attack and stroke with Vioxx. Bextra hits the market.

September 30, 2004: The Adenomatous Polyp Prevention on Vioxx (APPROVe) study shows patients taking Vioxx were twice as likely to suffer heart attack and stroke. As a result, Merck withdraws Vioxx.

December 9, 2004: The FDA announces side effects related to Bextra; asks Pfizer to add black-box warning to label.

December 17, 2004: The National Cancer Institute halts a colon polyp study due to an increased cardiovascular risk in Celebrex users. The FDA notes cardiovascular risks are not seen in a similar study with Celebrex.

December 20, 2004: The NIH halts the Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT) because it suggests naproxen users had an increased risk of heart attack or stroke.

December 23, 2004: The FDA formally urges limited and careful use of COX-2 inhibitors and traditional NSAIDs.

February 16-18, 2005: The FDA Advisory Panel determines naproxen (Naprosyn) was not associated with cardiovascular risk and chides the NIH for scaring the public. They also recommend that COX-2s remain on the market.

April 7, 2005: FDA asks Pfizer to pull Bextra off market. Manufacturers of OTC and prescription NSAIDs, as well as Celebrex, are asked to make label changes.

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