Delay in Removal of Meridia Criticized

October 26, 2010, 1:30PM. By Gordon Gibb

Washington, DCThe headline says it all: 'Why did it take so long to get this diet pill off the market?' The October 25th edition of the venerable Globe and Mail, one of two newspapers published nationally in Canada, observed that Meridia sibutramine—a drug that allows a dieter to feel full and thus be less compelled to linger in the buffet line—was approved the same year that Redux, Ponderal and Pondimin were pulled off the market for health reasons.

Now, Meridia has suffered the same fate.

The manufacturer of Meridia, Abbott Laboratories, voluntarily pulled the diet drug off the market after being requested to do so by the US Food and Drug Administration (FDA). The nail in Meridia's coffin stemmed from the results of a three-year study, funded by Abbott, that concluded sibutramine raises a patient's risk of stroke, heart attack and cardiovascular death.

Abbott continued to defend Meridia even while pulling the drug, noting that in its view the benefits outweighed the risk—and that any concern for potential Meridia heart attack was clearly outlined on the product label. Patients with pre-existing heart conditions were warned against taking the appetite suppressant.

However, critics of such a stance note that it is not uncommon for doctors to miss looming heart problems in people who fail to present symptoms. Further, those who are obese are already at risk for heart problems, added Dr. Gregory Curfman, executive editor of the New England Journal of Medicine.

The results of the Abbott-funded clinical trial were published in the respected medical journal in September, with an accompanying editorial co-authored by Curfman. "We're not against diet pills. It's just that this is a tough problem," he wrote. "It's been very difficult to come up with diet pills that have an acceptable risk profile."

He noted that 10 years is a long time to come to the conclusion that a drug isn't safe. The Globe and Mail said that reports of Meridia side effects began appearing soon after Meridia was approved in the US in 1997, prompting the manufacturer to launch a post-market clinical trial.

"I think it took a decade or more to establish that sibutramine is really not a safe enough compound, and that's too long," said Dr. Curfman. The editorial he co-authored called for the drug's removal.

The potential of the drug for raising heart rate and blood pressure also resulted in a risk for Meridia stroke. Patients lost, on average, no more than 10 pounds while on the diet drug. Meanwhile, a class action lawsuit has been filed in Canada, with filings October 12th in Montreal and October 13th in Toronto.