Patients taking the highest recommended daily dosage of the arthritis drug Vioxx had three times the risk of heart attack or sudden cardiac death when compared to individuals taking the arthritis drug Celebrex, according to a new government study.
The study, funded by the U.S. Food and Drug Administration, compared the data of 40,405 Kaiser Permanente patients who were prescribed Celebrex and 26,748 patients who were prescribed Vioxx.
Kaiser Permanente, which is one of the nation’s largest health maintenance organizations, is said to be considering how it prescribes Vioxx, the Wall Street Journal said last week.
Merck & Co., the maker of Vioxx, said it strongly disagrees with the conclusions of the observational analysis by Dr. David Graham, lead investigator for the study.
“This analysis is a retrospective database analysis – not a clinical trial, ” Merck said in a statement. “Observational analyses have limitations, often conflict with each other, and must be interpreted within the context of data from large, randomized, controlled clinical trials. Randomized, controlled clinical trials are the gold standard to evaluate safety and efficacy.”
Merck added: “It is important to note that, although the analysis was funded by the Food and Drug Administration under contract with Kaiser Permanente, the conclusions presented by the authors do not necessarily reflect the views of the FDA.”.
(via Reuters)
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