Are we looking at Fen-Phen all over again? This month the FDA will decide the fate of the controversial diet pill Meridia [sibutramine], America’s second-most popular prescription diet drug. That decision may be influenced by a recent editorial in the New England Journal of Medicine titled, "Sibutramine-Another Flawed Diet Pill," which says the drug should "be pulled from the market after a new study showed an increased risk in heart attacks in some patients." Meridia already contains a label warning that the drug should not be used in patients with known cardiovascular disease, but the authors of the editorial point out that "many patients…have cardiovascular disease and don’t know it. How are you supposed to identify those patients who might be put at risk by putting them on drugs like sibutramine?" They further wrote that "since Meridia has a worrisome cardiovascular risk profile, it’s difficult to discern a credible rationale for keeping this medication on the market."
After Meridia was approved in 1997, the drug’s manufacturer, Abbott Laboratories, was asked by European regulators to conduct research on the drug in people with a history of cardiovascular disease, diabetes, or both. The "randomized study of 9,804 overweight or obese people found that the risk of a stroke, heart attack, cardiac arrest, or cardiac death was 16% higher among people taking Meridia, compared with those taking a placebo." Specifically, "nonfatal heart attacks occurred in 4.1% of sibutramine users and 3.2% of the placebo group, and nonfatal strokes occurred in 2.6% of sibutramine users and 1.9% of the placebo group," but there "was no increased risk of heart attack or stroke in people with diabetes alone."
The authors of the study, three of whom are Abbott employees, concluded that the trial results did little more than show that patients with heart problems should not be prescribed Meridia. But, the NEJM editors believe the current warning does not address the risk to consumers who are unaware of their cardiovascular diseases. There’s no safe and effective substitute for diet and exercise, despite what the drug companies spend on advertising to convince us otherwise.