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Merck & Co. Announce Vioxx Recall

According to their press release, Merck states that an increased risk of heart attack and stroke became evident only after 18 months of the drug being used by patients participating in a study on colon polyps.

But according to a warning letter sent in September of 2001, Merck was aware of an increased cardiovasular risk...and so was the FDA.

• Were the participants in the new study made aware of the increased risks?
• Should the FDA have allowed the study to move forward?

Warning letter from the FDA:

"You have engaged in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed in the Vioxx Gastrointestinal Outcomes Research (VIGOR) study, and thus,...more

 

 

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