The Food and Drug Administration has refused to ban the weight loss drug Meridia. The agency rejected a petition filed by Public Citizen, asking that the Abbott Labs drug be banned because of concerns that it caused heart attacks and strokes in some patients.
In a letter to Public Citizen, the FDA said it believes that the drug's "overall risk-benefit profile supports it remaining available as a prescription drug for the treatment of appropriately selected obese patients."
"Once again, the FDA is siding with a large drug company, much as the agency did several years ago with Merck concerning Vioxx, when it failed to demand a black box warning on that drug," said Sidney M. Wolfe, MD, Director of Public Citizens Health Research Group."For a drug such as Meridia to be approved or for it to stay on the market, there must be evidence that its benefits outweigh its risks. Evidence prior to its approval and more than 50 cardiovascular deaths, many in young people, since its approval confirm that its benefits do not outweigh its risks and that it should be removed from the market despite efforts by the FDA/Abbott duo to keep the drug alive," Wolfe said.
The FDA said it was continuing to monitor the drug's safety profile.
The FDA said it couldn't conclude that the reports of heart attacks and strokes were caused by Meridia and noted that such events "are very common in patients with obesity." However, the agency said it is "plausible" that Meridia could raise the risk for some cardiac events.
But in a prepared statement Wolfe questioned whether all of the deaths caused by the drug had been reported: "A 3/21/02-4/03/02 FDA inspection report of the Abbott Laboratories plant in Abbott Park, Ill., found that '[one] death associated with Meridia was not reported and several records [involving seven other deaths] reviewed showed that the adverse drug information reported to FDA was either not accurate, not supported by source data, or was missing additional information found in the source data.'"
The FDA said it received 224 reports of nonfatal heart attacks and strokes from November 1997 through August 2003 among Meridia users. It received 54 reports of deaths, including 30 that were cardiovascular-related.
Last year FDA scientist David Graham questioned whether Meridia was effective enough to stay on the market during congressional testimony about how the agency handled safety questions surrounding Merck & Co's Vioxx, taken off the market in September.
Wolfe also questioned the drug's effectiveness, particularly when weight against its risks.
"In one of the only independent reviews of this drug by researchers from the University of Washington, published a year ago but predictably not mentioned by either the FDA or by Abbott in their responses to our petition, the authors concluded that: 'Weight loss with sibutramine was associated with modest increases in heart rate and blood pressure. There was no direct evidence that sibutramine reduces obesity-associated morbidity or mortality. Thus, we conclude that there is insufficient evidence to accurately determine the risk-benefit profile for sibutramine,'" Wolfe said.
Clinical studies have shown the drug can help people lose 5% to 10% of their body weight when used in conjunction with a program of diet and exercise.
