Vioxx Caused 88,000 to 140,000 Cases of Serious Heart Disease
Dr. David J. Graham Study Published in The Lancet Shows Recent Findings for Adverse Side Effects of Vioxx
A January 2005 article in British medical journal The Lancet concluded that patients taking Vioxx had a 34 percent greater chance of getting a coronary heart disease than those using other arthritis medications, and that a significant number of patients taking Vioxx died as a result of adverse side effects. FDA Doctor David Graham, who presented some of his material at a Senate hearing in November 2004, authored the Lancet article. The complete data from the study, which used data from Kaiser Permanente, a California health insurer, analyzed patients between 18-84 years of age treated with Vioxx or other non-steroidal anti-inflammatory drugs (NSAID) between January 1, 1999 and December 31, 2001. After reviewing the records of 1.4 million patients at Kaiser Permanente, the findings were that Vioxx significantly increased risk of heart attack by as much as 34% and that the use of Vioxx was not any more beneficial to patients than other drugs like ibuprofen or naproxen, which carry less risk of side effects for the patient.
Vioxx is a COX-2 inhibitor drug, a class which also includes Celebrex, Mobic, Bextra, Dynastat and Arcoxia. COX-2 drugs are relatively new and designed to ease pain and inflammation without damaging the stomach, but some COX-2 drugs have been found to have side effects including serious coronary heart disease, which can be fatal in 44% of patients.
The study has aroused controversy surrounding drug safety in the United States. At the time Vioxx was voluntarily withdrawn from the market, studies existed which some say ought to have prompted earlier mandatory withdrawal from the market, either by the FDA or the manufacturer. The American Journal Archives of Internal Medicine joined a chorus of others, including consumer watchdog group Public Citizen, calling for an overhaul of the way the US FDA approves and monitors new drugs. "The FDA has become a little bit too beholden to the drug companies and is either unwilling, afraid, or unable to get them to do the safety studies that need to get done once there's a signal that there may be a problem," said Dr. Jerry Avorn of Harvard in an editorial. Dr. Graham says he was prevented from releasing his findings until recently because he was pressured by the FDA not to do so.
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