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Vioxx Causes Heart Attack
Merck contacted FDA on September 27, 2004:
To request a meeting to discuss with the Agency the Data Safety Monitoring Board's decision to halt Merck's long-term study of Vioxx in patients at increased risk of colon polyps. Merck and FDA officials met the next day, September 28, and during that meeting the company informed FDA of its decision to remove Vioxx from the market voluntarily. The data presented demonstrated an increase in risk in cardiovascular risk and stroke starting at the eighteen-month time point compared to placebo. This was the first demonstration of a difference in comparison to a placebo group and supported the previous signal seen in the VIGOR trial and some of the epidemiologic studies.
Conclusion:
In summary, FDA worked actively and vigorously with Merck to inform public health professionals of what was known regarding CV risk with Vioxx, and to pursue further definitive investigations to better define and quantify this risk. FDA also reviewed and remained current on new epidemiologic studies that appeared in the literature. Indeed, the recent study findings disclosed by Merck, leading to its decision to voluntarily withdraw Vioxx from the marketplace, resulted from FDA's vigilance in requiring these long-term outcome trials to address our concerns.
Detecting, assessing, managing and communicating the risks and benefits of prescription and over-the-counter drugs is a highly complex and demanding task. FDA is determined to meet this challenge by employing cutting-edge science, transparent policy, and sound decisions based on the advice of the best experts in and out of the agency. We are confident that the additional activities discussed above will strengthen the agency's program to greater ensure the safety of medical products that make a major contribution to the health and quality of life of millions of Americans. Medicines that receive FDA approval are among the safest in the world, and the measures we are taking are designed to strengthen this quality, as well as consumer confidence that FDA's processes ensure the highest protection of the public health.
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