A 13-year-old diet pill is getting fresh scrutiny for side effects.
A panel of experts advising the Food and Drug Administration will vote Wednesday on whether the diet pill Meridia should stay on the market, despite heart and stroke risks. New data sharpen the question.
Come Wednesday, the diet drug Meridia will be at a crossroads.
A panel of experts convened by the Food and Drug Administration will take a look at the cardiovascular risks of the daily pill and will vote on whether it should stay on the market.
Questions about the medicine, which raises blood pressure and heart rates as it helps some people lose weight, aren't new. But finally there's more information, including a recent study sponsored by Abbott Labs, maker of Meridia.
That study, called SCOUT for short, found Meridia increased the risk for non-fatal heart attacks and strokes in people at risk for cardiovascular disease. Editors at the New England Journal of Medicine called for Meridia to be taken off the market.
In briefing documents released Monday, there's a review done late last year by FDA scientists of 17 deaths with cardiovascular causes that involve patients taking Meridia between 2002 and 2009. The reports, for the most part, weren't documented very well, the agency says. Still, the scientists conclude that the deaths "can not be dismissed as coincidental and unrelated to" Meridia, given the medicine's known tendency to raise blood pressure and pulse.
Another look at more reports of deaths confirmed previous findings and made note of the fact that "young people without known risk factors (aside from obesity) have died" soon after starting Meridian and that doctors don't always heed warnings against prescribing the drug for people with known cardiovascular disease.
Abbott, for its part, said in a memo that the SCOUT results don't "fundamentally alter the established positive benefit-risk profile" for Meridia. Still, the company acknowledged that more could be done to minimize risks and proposes provide more prominent safety advice as part of the instructions for use.
As it is, doctors and patients have already been shying away from Meridia. U.S. prescriptions for the drug had fallen from a peak of about 1.6 million in 2001 to less than 300,000 in 2008. Copyright 2010 National Public Radio. To see more, visit http://www.npr.org/.