WASHINGTON, Sept. 13 (UPI) — A U.S. Food and Drug Administration advisory committee says it will discuss removing the diet drug Meridia from the market because of health concerns.
The drug, already pulled from shelves in Europe, has been the focus of an ongoing FDA safety review of side effects in patients with a history of heart disease or diabetes, The Wall Street Journal reported.
On Wednesday, the agency’s endocrinologic and metabolic drugs advisory committee, made up of non-FDA medical experts, will be asked to vote on what additional regulatory action it thinks the FDA should take, or if the product should be withdrawn from the U.S. market, the newspaper said.
The FDA usually follows the advice of its advisory committees but isn’t required to do so.
The panel will discuss a clinical study conducted in patients with a history of heart disease or diabetes. It showed patients on Meridia had a higher rate of cardiovascular events compared to patients on a placebo medication.
Given the modest decrease in body weight seen with most patients taking Meridia, “even a small increase in cardiovascular risk seems unwarranted,” an FDA memo said.
Abbott Laboratories, the makers of Meridia, said it supports placing a boxed warning on the product giving doctors “advice on monitoring and discontinuation of therapy based on blood pressure, pulse and weight loss parameters.”
A boxed warning is the FDA’s toughest warning on a drug label.
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