http://www.gpwlaw.com/news/news/personal-injury/2001/05/22/merck-confirms-favorable-cardiovascular-safety-profile-of-vioxx/ Just another WordPress weblog Thu, 21 Aug 2008 20:37:52 +0000 http://wordpress.org/?v=2.3.3 http://www.gpwlaw.com/news/news/personal-injury/2001/05/22/merck-confirms-favorable-cardiovascular-safety-profile-of-vioxx/#comment-7 » Vioxx drug recall; pain and arthritis drug shown to increase risks of stroke, heart attack » Blog Archive GPWLaw News Fri, 04 May 2007 16:06:13 +0000 http://www.gpwlaw.com/news/news/personal-injury/2001/05/22/merck-confirms-favorable-cardiovascular-safety-profile-of-vioxx/#comment-7 [...] Vioxx was FDA approved in May 1999. A June 2000 study—VIGOR (VIOXX GI Outcomes Research)—first indicated the connection between Vioxx and heart attacks, raising health concerns about chronic use of the drug. As late as September of 2001, the FDA sent a warning letter to Merck accusing it of glossing over these findings in their advertising and other literature. The FDA’s letter mentions, among other things, a press release issued in May of 2001: We have identified a Merck press release entitled, “Merck Confirms Favorable Cardiovascular Safety Profile of Vioxx,” dated May 22, 2001, that is also false or misleading for similar reasons stated above. Additionally, your claim in the press release that Vioxx has a “favorable cardiovascular safety profile,” is simply incomprehensible, given the rate of MI [myocardial infarctions] and serious cardiovascular events compared to naproxen. The implication that Vioxx’s cardiovascular profile is superior to other NSAIDS is misleading; in fact, serious cardiovascular events were twice as frequent in the VIOXX treatment group (101 events, 2.5%) as in the naproxen treatment group (46 events, 1.lYo) in the VIGOR study. [...] […] Vioxx was FDA approved in May 1999. A June 2000 study—VIGOR (VIOXX GI Outcomes Research)—first indicated the connection between Vioxx and heart attacks, raising health concerns about chronic use of the drug. As late as September of 2001, the FDA sent a warning letter to Merck accusing it of glossing over these findings in their advertising and other literature. The FDA’s letter mentions, among other things, a press release issued in May of 2001: We have identified a Merck press release entitled, “Merck Confirms Favorable Cardiovascular Safety Profile of Vioxx,” dated May 22, 2001, that is also false or misleading for similar reasons stated above. Additionally, your claim in the press release that Vioxx has a “favorable cardiovascular safety profile,” is simply incomprehensible, given the rate of MI [myocardial infarctions] and serious cardiovascular events compared to naproxen. The implication that Vioxx’s cardiovascular profile is superior to other NSAIDS is misleading; in fact, serious cardiovascular events were twice as frequent in the VIOXX treatment group (101 events, 2.5%) as in the naproxen treatment group (46 events, 1.lYo) in the VIGOR study. […]

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