Meridia Side Effects Being Reviewed by FDA for Risk of Heart Problems

The FDA has begun an expedited review into potential side effects of Meridia, a weight loss drug that may cause a higher number of cardiovascular events, such as heart attacks, strokes, resuscitated cardiac arrest or death.

Following preliminary data from a recent study that compared use of the drug to a sugar pill, the FDA released an Early Communication on Friday about an ongoing safety review into the potential Meridia heart problems. The agency indicates that no conclusions have been made about the findings, but the review will be expedited due to the seriousness of the risk.

Meridia (sibutramine), which is manufactured by Knoll Pharmaceutical Co, was approved by the FDA in 1997 as a prescription-only weight loss supplement for obese patients with other risk factors such as diabetes, high cholesterol and controlled blood pressure.

“The analysis of these data is ongoing and FDA is making no conclusions about the preliminary findings at this time,” said the agency in a statement posted Friday on their website. “These findings highlight the importance of avoiding use of sibutramine (Meridia) in patients with a history of coronary artery disease (heart disease), congestive heart failure (CHF), arrhythmias, or stroke, as recommended in the current sibutramine labeling.”

The study, Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of Cardiovascular Event (SCOUT), was conducted by Knoll Pharmaceuticals and the European Medicines Agency. Researchers initially hoped to show that weight loss through the use of Meridia actually lowered the risk of cardiovascular events; instead the preliminary data may suggest that Meridia side effects actually increase the risk.

The research looked at 10,000 patients who were obese and over 55 years old with a history of heart disease or type 2 diabetes and other risk factors. In preliminary results reported to FDA in mid-November, researchers found that 11.4% of patients suffered Meridia heart problems, including heart attack, stroke, resuscitated cardiac arrest and death, compared to only 10% of patients given a placebo. The researchers reported that the result was higher than expected.

The consumer advocacy group Public Citizen lists Meridia as a “Do Not Use” pill on its Worst Pills, Best Pills list. The group says that the risk of side effects with Meridia, combined with the limited weight loss benefits, make the drug not worth the risk for consumers.

FDA Early Communications are designed to inform the public about ongoing safety reviews, and does not mean that the regulatory agency has determined that a cause and effect relationship exists. Healthcare providers have been urged to avoid use of Meridia among patients with a history of heart disease, congestive heart failure, arrhythmias or stroke, as recommended in the current labeling. Patients have also been urged to talk to their doctors about whether Meridia is right for them. Once the expedited review is complete, the FDA will communicate their findings and any new regulator actions or warnings.