Monday, May 5, 2008

Food and Drug-The VIOXX STORY

MORE FACTS BEHIND THE NEWS

One of the largest and most well known failures of the Food and Drug is the Vioxx .case. An April 8, 2008 article in USA TODAY reports that FDA researcher David Graham, a lead scientist on a Vioxx study linked Vioxx to 27,000 “heart sudden cardiac deaths nationwide from the time Vioxx came on the market in 1999 through 2003”.

Vioxx was one of several medicines developed to be safer than traditional anti-inflationary drugs that sometimes cause gastrointestinal hemorrhages and can result in death. However a study completed in 1999 shortly after FDA approval showed better GI safety than naproxen but ”an alarming increase in cardiovascular problems”.

For the next five years Merck manufacturer of Vioxx continued to minimize unfavorable findings. Finally, upon completion of David Graham’s database analysis of 1,400,000 patients that showed a substantially higher risk of heart problems with Vioxx, the Merck Co. then removed Vioxx from the market.

No comments: