FDA issues a warning to Merck over Vioxx

Published: 20-Dec-2001
Regulatory


The FDA has issued a warning letter to Merck & Co over the company's promotion of its COX-2 inhibitor, Vioxx. The FDA alleges that Merck misrepresented the results of the VIGOR study in a promotional campaign, minimising the potentially serious cardiovascular findings. The FDA says that the firm discounted the fact that the VIGOR study showed patients on Vioxx having a 4–5 fold increase in heart attacks compared with patients on the comparator non-steroidal antiinflammatory drug naproxen.

The FDA also says Merck omitted important risk information relating to dosage — namely the potentially serious effects of parallel use with warfarin.

The FDA has requested Merck issue a 'Dear Doctor' letter to correct false or misleading information, which must be submitted to the FDA for review prior to its release, as well as ceasing all promotional activity in violation of the facts. The company also has to provide a written statement of its intent to comply with the two conditions.

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