Meridia — Weight Loss or Health Loss?

Against the better judgment of both the physicians who reviewed the data for the Food and Drug Administration (FDA) and the FDA’s external Advisory Committee, the weight loss drug Meridia (sibutramine) has been on the market for over five years. Both the agency’s own doctors and its advisors are on record as saying that the benefits (loss of a few pounds in weight) do not outweigh the risks (increased blood pressure and thus increased risk for heart attack and stroke).

Nevertheless, in February 1998 the FDA approved Meridia on the assumption that physicians could identify those patients likely to have dangerous increases in blood pressure. That assumption has not proven valid, either because doctors are not monitoring patients closely enough or because it is not possible to
predict who will be at risk. Public Citizen has monitored the drug since its launch. In March 2002, we petitioned the FDA to ban the drug (http://www.citizen.org/
publications/release.cfm?ID=7273) and have now updated that petition with a further analysis of the
FDA’s adverse drug reaction database (http://www.citizen.org/
publications/release.cfm?ID=7160).

Through May 2003, there have been a total of 49 cardiovascular deaths, 68% of which were people in their 20s, 30s, and 40s, groups in which such deaths are otherwise rare. One case of cardiac arrest occurred in a 28-year-old woman. There were, in addition, at least 126 serious cardiovascular adverse events such as heart attacks, irregular heartbeats, and hypertension. Fifty percent of these serious events led to hospitalization. One needs to keep in mind that, at most, 10% of adverse events are reported to the FDA, so these numbers are probably ten times too low.

Our latest analysis revealed a new finding: adverse effects on the developing fetus, including cases of cardiovascular birth defects, congenital malformations of the central nervous system, spontaneous abortions, and stillbirths. Much of this could have been predicted from the pre-approval animal data, but the drug’s label offers no specific warnings.

The average weight loss in obese people taking a moderate dose of Meridia for one year is only 6 1/2 pounds; no significant additional weight loss occurs after four months of use. Even that trivial weight loss may prove fleeting: up to a third of it vanishes within six weeks of stopping Meridia. There is no justification for continuing to market a drug that provides minimal weight reduction while increasing the likelihood of injury and death. No matter how attractive quick-fix solutions to obesity might seem, we stand by this age-old advice: the only safe and effective way to lose weight is through a calorie-restricting diet and exercise.