The Food and Drug Administration (FDA) is now weighing whether to ban the diet pill Meridia following a split vote by its advisory panel.
The panel voted 8-8 on Sept. 15. Half the members voted to continue marketing the drug, which a study has shown increases risk for heart attacks and strokes. Half the panel voted to remove it from the shelves. European regulators banned the drug in January, but the FDA had wanted input from its advisory panel before acting.
Meridia is produced by Abbott Laboratories and has been on the market since 1997. Data released in November 2009 shows that when patients with heart disease took Meridia, they had a more than 11 percent risk of cardiovascular risks, compared with 10 percent taking a placebo. The study included 10,000 patients.
Meridia is one of only three prescription pills currently approved for weight loss. Many say the marginal benefits are not worth the risk. Among study participants, the average patient lost five pounds and 30 percent kept the weight off.
“We do make the assumption that weight loss is beneficial and that translates into clinical benefits, but we’re not presented with those here,” said Dr. Katherine Flegal of the Centers for Disease Control and Prevention. “On the whole, there are not the benefits that justify the risks.”
Prescriptions of Meridia have declined in recent years. About 283,000 Meridia prescriptions were filled in the U.S. last year, just more than half the number in 2005.
To read more about the Meridia product ban discussion, click here.
The Boston product liability lawyers at Breakstone, White & Gluck handle complex cases of product recalls and defective products impacting Massachusetts and New England residents. We have experience handling cases involving prescription drugs and recalled medical devices. If you have a case, contact us today for a free consultation at (617) 723-7676 or use our form.