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WEDNESDAY, Sept. 1 (HealthDay News) -- A new study is linking the popular weight loss drug Meridia to an increased risk of non-fatal heart attacks and stroke, although taking the drug did not seem to up the risk of death in patients with a history of heart problems.
The finding is stirring mixed reactions from experts.
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According to the authors of the trial, which was funded by Meridia's maker, Abbott, the findings are generally in line with what has been known about the drug and shouldn't change how it is used.
"The only time you've got an increase in heart attacks or strokes were in those patients who had had previous heart disease or strokes, in other words, the people who . . . should never have received the drug in the first place," said Dr. Philip T. James, a professor at the London School of Hygiene and Tropical Medicine in England, and first author on the paper, which appears in the Sept. 2 issue of the New England Journal of Medicine.
Since January, Meridia (sibutramine), has carried a label warning that it should not be used by people with preexisting heart disease, so "the current prescription is entirely appropriate," James said.
However, not everyone agrees. The U.S. Food and Drug Administration is slated to meet in September to decide if more regulatory action -- perhaps a tougher "black-box" warning or even removing Meridia from the market -- should be taken.
According to Dr. Greg Curfman, executive editor of the NEJM and co-author of an accompanying editorial, the FDA's January warning was based on preliminary information only. The new study results represent the first hard data, "the first outcomes trial," he said.
Based on the findings, he and others wonder if the drug is worth keeping around.
The drug did not seem to make people healthier, Curfman said. "Some people were actually made worse," he said. "All this taken together results in an unfavorable risk-benefit profile and, based on that, we don't see a rationale for keeping this on the market."
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