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FDA Panel Is Split on Ban of Diet Drug Meridia

Advisory Panel Votes 8 to 8 on Whether to Keep Weight Loss Drug on the U.S. Market

Conflicting Viewpoints

The Public Citizen Health Research Group, which first petitioned FDA to ban Meridia in 2002, says the drug poses a "deadly tradeoff" between modest weight loss and the danger of heart attack and stroke.

Others say Meridia can be made safe by closely monitoring things like patients' pulses and blood pressure readings. "I think the risk is manageable under a physician's care," says Melanie Coffin, the panel's consumer representative.

Abbott, which manufactures Meridia, had pledged step up warnings and educational efforts for doctors and patients if the drug is allowed to stay on the market.

"The vote highlights the complexity of this scientific debate," Eugene Sun, MD, the company's vice president of global pharmaceutical development, said in a statement. "We continue to believe that there are appropriate and identifiable patients that derive benefit from sibutramine."

Meridia's popularity has plummeted in recent years, particularly since the release of the Scout trial's data in November. Only an estimated 280,000 prescriptions were filled last year in the U.S., according to the tracking firm IMS Health.

Some experts worried that the list of effective treatments available to patients had grown thin.

Banning Meridia "just takes one more option off the table," Coffin says.

Sanjav Kaul, MD, a panel member and cardiologist at Cedars-Sinai Medical Center in Los Angeles, suggests that Meridia had turned out to be a disappointment to patients hoping to use it to safely lose weight.

"It was touted to be a magic bullet, but in some cases it's more bullet than magic," he says.

Colman says the FDA now has to decide if the clear benefits of even modest weight loss to most patients is worth a rise in cardiovascular risk in some of them. The FDA will also likely consider what vital signs doctors should monitor, and how often they should monitor them, to minimize the drug's risks.

The advisory panel's split vote "certainly doesn't make it easier for us," Colman told reporters.

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