FDA warnings

The US Food and Drug Administration sent Vioxx' manufacturer Merck & Co. a "Warning Letter" (link to PDF) on September 17, 2001, requiring them to cease certain promotional activities for Vioxx.

The letter warns Merck & Co. that their promotional efforts are misleading. It says the company's hypothetical explanation for the findings of the Vioxx Gastrointestinal Outcomes Research (VIGOR) study (which found a higher incidence of heart attacks in people taking Vioxx) minimizes safety issues and recklessly fails to warn consumers of the increased risk of heart attacks.

The letter states that Merck's promotions also improperly "minimize the risks of a Vioxx/Coumadin (warfarin) drug interaction (serious risk of bleeding), omit risk information, make unsubstantiated superiority claims against other NSAIDs, and promote Vioxx for unapproved uses and an unapproved dosing regimen."