Meridia has been on the market since 1997, but a report released last November showed patients with heart disease taking the drug had a more than 11 percent risk of cardiovascular risks compared with 10 percent of those taking a placebo. European regulators pulled the product off store shelves in January.
The FDA released its 170-page safety review Monday on Meridia. It contains analyses by half a dozen agency scientists, at least two of whom appear to favor withdrawing the drug. But the FDA points out that withdrawing the drug is not its only option. They may simply add more warning labels.
Meridia has been criticized by public safety advocates for several years. Earlier this month, the editors of the New England Journal of Medicine called on the FDA to withdraw the pill.
"It is difficult to discern a credible rationale for keeping this medication off the market," the journal's editorial concluded.
On Wednesday, the FDA will meet with an outside panel of experts who will weigh in on the course of action the FDA should take. The FDA is not required to follow the group's advice, although it often does.
The Associated Press contributed to this report.
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