Meridia has been shown to slightly raise blood pressure and heart rate, and the cardiovascular risk associated with the drug has been known for years. Since being approved by the FDA in 1997, Meridia has carried a warning on its label that says the drug should not be used in people with a history of heart disease, heart failure, heart-rhythm problems, or stroke.
In January 2010, after reviewing the preliminary data from the SCOUT study, the FDA asked Abbott to strengthen the warning. The European Medicines Agency—the European equivalent of the FDA—chose to suspend sales of the drug in the European Union.
In an editorial accompanying the study, three New England Journal of Medicine editors suggest that the heart risk associated with Meridia is not justified by the weight loss seen in the study—about 9.5 pounds (or 4.5% of initial body weight) after one year, on average. “[I]t is difficult to discern a credible rationale for keeping this medication on the market,” the editors write.
The FDA would be going too far if it pulled the drug from the market, says Donna H. Ryan, MD, associate executive director for clinical research at the Pennington Biomedical Research Center, in Baton Rouge, La. She notes that the patients taking Meridia who were at greater risk for heart attack and stroke in the SCOUT study—those with preexisting cardiovascular disease—are already precluded from taking the drug.
The study should not be interpreted to mean that the drug shouldn’t be used at all, says Dr. Ryan, who prior to 2008 served as a consultant for Abbott and other manufacturers of obesity drugs. “The study doesn’t really support that, and indeed, in the population where you didn’t have preexisting cardiovascular disease…there is no increased risk,” she says.
Sidney Wolfe, MD, the director of the health research group at Public Citizen, a consumer advocacy organization that petitioned the FDA to ban Meridia for safety reasons in 2002, says that even people who haven’t been diagnosed with heart disease should avoid Meridia. Some obese people have unrecognized heart problems that may be aggravated by the drug, he says.
Meridia “should never have been approved in the first place,” Dr. Wolfe adds.
The FDA’s advisory committee on endocrinologic and metabolic drugs will discuss Meridia on September 15. The agency is not required to follow the committee’s recommendations, but it typically does.
