July 16, 2007
European Drug Regulatory Authority Should Remove Arthritis Drug Etoricoxib and Weight Loss Drug Rimonabant From European Market
Public Citizen Warns European Medicines Agency About Serious Risks That Caused FDA to Ban Drugs’ Marketing in U.S.
WASHINGTON, D.C. – The European drug regulatory authority should immediately remove from the European market the arthritis drug etoricoxib (Arcoxia) and the anti-obesity drug rimonabant (Accomplia), according to a letter sent by Public Citizen to the European Medicines Agency (EMEA) today. The agency is meeting this week to discuss, among other topics, a possible change in the regulatory status of rimonabant.
Although etoricoxib has been available in the EU since 2002, and rimonabant since 2006, these two compounds have been documented to have a myriad of problems with safety and efficacy. Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, and Public Citizen researcher Benjamin Wolpaw urged the EMEA in their letter to review the latest data guiding the U.S. Food and Drug Administration’s (FDA) decisions not to allow U.S. marketing for the two drugs.
In the past three months, separate FDA advisory committees evaluating etoricoxib and rimonabant voted 20-1 (April 12th) and 14-0 (June 13th), respectively, against approval of these drugs for use in the United States.
“The decision of each of these advisory committees was that the risks of the drugs outweighed their benefits and that they were not fit for use by people in the U.S.,” Wolfe said. “We hope that the EMEA will reconsider their stance on these two drugs and we strongly urge that both etoricoxib and rimonabant be promptly removed from the market.”
Wolfe warned in testimony on April 12 before an FDA advisory committee that etoricoxib causes serious heart problems without offering the type of gastrointestinal advantage that the drug’s maker claims. The arthritis drug is a COX-2 inhibitor, a class of drug that has been shown to increase the risk of heart attack and other cardiovascular events. Another COX-2 inhibitor, Vioxx, was pulled from the U.S. market in 2004 after studies linked it to increased risks of heart attack and stroke. The FDA advisory committee that reviewed etoricoxib could not justify recommending its approval because it offers no unique benefits but carries a serious heart risk not associated with older pain relievers such as naproxen.
Wolfe also testified before an FDA advisory committee meeting on June 13 about the risks associated with rimonabant. The anti-obesity drug produces only modest weight loss and has been shown to cause serious physical and psychological adverse effects, including a significantly increased risk of suicidal thoughts. The drug inhibits brain receptors involved in eating, but has also been shown to act on other areas of the brain as well as peripheral organs, raising serious concerns about the drug’s toxicity. A report from the EMEA acknowledges such adverse effects in animals as increased birth defects, impaired fetal survival, convulsions, liver toxicity, chromosomal aberrations and carcinomas.
“The EMEA should spare Europeans from these two drugs that have been thought too dangerous, relative to their benefits, to be allowed on the U.S. market,” said Wolfe. Failure to do so, he concluded, would ensure continuing damage to the health of Europeans from drugs with no unique benefits and well-documented risks.
READ the full text of Public Citizen’s letter to the EMEA.
READ Public Citizen’s testimony to the FDA about etoricoxib.
READ Public Citizen’s testimony to the FDA about rimonabant.