March 19, 2002
FDA Should Immediately Ban Dangerous Diet Drug Meridia
Risks of Heart Problems Far Outweigh Benefits, Public Citizen Petition Says
WASHINGTON, D.C. ? The Food and Drug Administration (FDA) should immediately remove the prescription diet medication Meridia from the market because it has been associated with 29 deaths and hundreds of serious adverse reactions since it was introduced in 1998, Public Citizen said in a petition filed today. The FDA knew prior to approving the drug that it significantly increased blood pressure and heart rates in many people and is only minimally effective, Public Citizen said.
Just two weeks ago, the Italian government pulled Meridia, the brand name for sibutramine, from the market following two deaths associated with its use there. Other European governments also are reviewing the drug, including France and the United Kingdom, where there have been more than 100 serious adverse reactions and two deaths.
“Not only does this drug contribute to major cardiovascular problems, but its effectiveness in lowering obesity is meager,” said Dr. Sidney Wolfe, director of Public Citizen?s Health Research Group, which filed the petition. “The FDA is aware of this and must take it off of the market.”
Even before it approved the drug, the FDA was concerned about the safety of Meridia. An FDA advisory committee in 1997 voted 5-4 that the benefits of the drug did not outweigh its risks. The FDA medical officer who reviewed it recommended that it not be approved because research showed the potential for heart problems.
Data obtained by Public Citizen through a Freedom of Information Act (FOIA) request show that from the time it was introduced in February 1998 to Sept. 30, 2001, there were almost 400 serious adverse reactions in patients taking Meridia. This included 19 cardiac deaths, including 10 in people under the age of 50, three of whom were women under 30. The average yearly weight loss for patients taking a standard 10 mg dose was only six and a half pounds more than the loss in those taking a placebo.
“There is no evidence that this drug has prolonged the life of a single patient, or reduced the risks of strokes or heart attacks tied to obesity,” Wolfe said. “Instead, it has left patients with only higher risks of injury or death from using it and high drug bills.”
Further, the FDA must raise the standard for approval of diet drugs and require drug makers to show an actual health benefit, rather than relying on short-term studies that merely demonstrate a statistical superiority over a placebo.
Since 1996, Public Citizen has petitioned for the removal of four other FDA-approved drugs ? the diet drug Redux, the diabetes drug Rezulin, the antibiotic Trovan and Lotronex, a drug for irritable bowel syndrome. Redux, Rezulin and Lotronex have been banned and Trovan severely restricted. In all of these drugs, as with Meridia, there was clear evidence of danger before their FDA approval.
To view the petition, please click here.