Diet Drug Danger: Meridia Raises Cardiovascular Risk
Sept. 15, 2010— -- Diet pill Meridia may garner new warning labels or be pulled from the market completely following today's meeting of the Food and Drug Administration's drug advisory committee.
In a vote this afternoon on the safety of the Abbott Laboratories' diet drug, panel members were split -- eight voted to boot the drug from the market while the remaining eight voted to keep it on the market with new safety restrictions.
Spurred by concern that Meridia might increase cardiovascular risk, Abbott Laboratories had sponsored a six-year trial, SCOUT, to further evaluate its safety, the results of which were reviewed today by the committee.
Now that results are in, it will be up to the FDA to consider the split decision and weigh whether the 16 percent increased risk in major adverse cardiac events seen in the trial is reason enough to restrict access or withdraw the drug from the U.S. market.
Given that patients on Meridia only lost five pounds more in the study than those on placebo, many doctors feel that this increased cardiovascular risk is simply not worth it.
"The key point here is that obesity itself is associated with increased risk of cardiovascular disease, so the rationale for prescribing obesity drugs is to improve outcomes [by lowering that risk]," says Dr. Kevin Niswender, assistant professor of medicine at the Vanderbilt University School of Medicine.
"A drug that is modestly successful at increasing weight loss but increases cardiac risk further, that's clearly an issue," he said.
Abbot Laboratories products containing Meridia's main ingredient, Sibutramine, were already pulled from the European market in January based on preliminary results from SCOUT.
