The weight loss pill Meridia may increase the risk of heart attacks, according to a company-sponsored study, and is set for review by the FDA next week.
New research indicates that Meridia, a weight loss pill manufactured by Abbott Laboratories, may increase the risk of heart attacks, prompting consumer advocates to call for the drug to be pulled from the U.S. market.
The study, published in the New England Journal of Medicine, examined more than 10,000 people over the age of 55 who were overweight or obese and had pre-existing heart disease, type 2 diabetes or both. Each person was given either Meridia or a placebo and participated in a diet and exercise program. The study found that on average when Meridia was taken for more than three years, the risk of having a heart attack or stroke was 16 percent higher. Researchers found no increased mortality rate, but Meridia patients did see an increase in heart rate and blood pressure.
The Food and Drug Administration (FDA) is set to review Meridia and its effects on heart risk before deciding whether to take further action against the diet pill. Europe has already banned the pill and recalled its marketing license in January of this year.
Abbott did disclose the increased heart risk, which led to a stronger label warnings for patients with pre-existing heart problems, and the company has said it will propose “risk management activities” at the FDA advisory meeting, but did not go into further detail.
The FDA will meet and make its final recommendations for Meridia on September 15. Until then, the future of the diet pill in the U.S. is unknown.