FDA/Kaiser Study Revises Cardiovascular Risk For Merck's Vioxx
This article was originally published in The Pink Sheet Daily
Executive Summary
The study, led by FDA Office of Drug Safety official Graham, shows a 1.34 relative risk for Vioxx compared to remote NSAID use after data were revised to "correctly apply enrollment criteria for cases and controls." The study was not powered to detect an effect for Vioxx based on duration of use.
You may also be interested in...
Crestor, Serevent Are Among Problem Drugs Cited By FDA Safety Reviewer
FDA Office of Drug Safety personnel will be publishing a paper on statins and rhabdomyolysis in an upcoming issue of the Journal of the American Medical Association, Associate Director for Science David Graham told the Senate Finance Committee during a Nov. 18 hearing on Merck's withdrawal of Vioxx
Celebrex Cardiovascular Safety Supported In FDA/Kaiser Study
FDA releases data from COX-2 cardiovascular safety study that was included in a Sept. 30 internal memo to Office of Drug Safety Director Seligman. The study shows Celebrex patients have lower cardiovascular safety risk compared to remote NSAID users.
FDA Has One Month To Mull Approval Of Merck's Arcoxia Following Vioxx Withdrawal
Arcoxia's user fee date is Oct. 30, but FDA could decide to wait for 18-month cardiovascular safety data from a 20,000-patient trial comparing etoricoxib with diclofenac. Merck says it will work with regulatory authorities in 47 countries where Arcoxia is marketed to discuss potential labeling changes resulting from the Vioxx study data.