Weight-Loss Drug Fattens Heart RisksDec 23, 2003 | www.consumerreports.org Is the diet drug sibutramine (Meridia) too dangerous to stay on the market? The Health Research Group at Public Citizen, a Washington-based consumer-advocacy organization, says it is, citing adverse events reported to the Food and Drug Administration.
From the drug’s introduction in February 1998 through March 2003, the FDA received reports of 49 deaths from cardiac arrest, heart attack, and heart arrhythmia in people who were taking sibutramine. Another 124 people developed cardiovascular conditions severe enough to require hospitalization. The manufacturer, Abbott Laboratories, declined to tell us how many people are taking the drug.
“We would like nothing better than to see an effective weight-loss drug, but Meridia is not it,” says Larry D. Sasich, Pharm.D., M.P.H., a researcher at Public Citizen. Obese people already are at risk for high blood pressure and heart problems. “So, the very people who would benefit most from weight loss face substantial risk from this drug,” says Sasich.
Sibutramine encourages weight loss in part by stimulating the sympathetic nervous system, which boosts heart rate and blood pressure. The mechanism is similar to that of amphetamines, as well as nutritional supplements containing ephedra, which have also been linked to cardiovascular problems.
A spokesman for Abbott says that several studies on obesity show significantly higher death rates than the fatalities that occurred with the use of Meridia. “That tells us this is not related to drugs, but rather to the underlying disease that these patients have,” says James Embrescia, D.O., who monitors product safety for Abbott.
In clinical trials, severely overweight people who used sibutramine for up to a year lost about 9 pounds more than patients who were given a placebo.
Still, the drug’s effects on blood pressure and heart rate are exactly the opposite of what would be expected from similar weight loss achieved through diet and exercise. Our medical consultants advise against using this and other weight-loss medications, since none have been tested for more than about two years and none have been proved to reduce the long-term risk of obesity-related illness and death.
Sibutramine should not be used by people with a history of high blood pressure or coronary-artery disease, disorders common in obese people, who may not be aware of their presence. Those who insist on taking the drug should be informed of the risks and have their blood pressure monitored frequently.