FDA Public Health Advisory: Safety of Vioxx

Posted by Clark Venable on 10/5/2004

FDA Public Health Advisory: Safety of Vioxx from the FDA and also a FAQ.

As far as I have been able to find out, the results that led to the early termination of the APPROVe trial have not been published. What seems to have happened is that the trial was terminated because interim analysis revealed the increased risk of heart attacks in those taking Vioxx for more than 18 months. Of note is the fact that the study enrolled fewer than three thousand patients, yet still possessed enough power to allow this conclusion, which suggests to me that complications were not rare (in which case a much larger study sample would have been needed to demonstrate this result).

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