Product Liability

FDA orders removal of weight loss drug Meridia

The Food and Drug Administration (FDA is removing the weight loss drug Meridia (sibutramine) because studies show the drug increases the risk of serious cardiovascular events such as heart attack and stroke.

Meridia was approved in November 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain people with other risks for heart disease. The drug was initially approved because clinical data showed that more people receiving sibutramine lost at least 5 percent of their body weight than people on placebo who relied on diet and exercise alone.

However, disturbing data began to surface from the Sibutramine Cardiovascular Outcomes Trial, known as SCOUT, part of a postmarket requirement to look at cardiovascular safety of sibutramine after the European approval of the drug. The trial demonstrated a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and death, in a group of patients given sibutramine compared with another group given placebo. The data also showed only a small difference in weight loss between the placebo group and the group that received sibutramine.

Meanwhile, the FDA has been cracking down on over-the-counter dietary supplements, including weight management supplements, several of which the FDA has found to contain sibutramine. On Friday, the FDA warned consumers that Slimming Beauty Bitter Orange Slimming Capsules contained undeclared sibutramine. These drugs carry the same risk as Meridia.

The FDA is advising physicians to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients are advised to talk to their health care provider about alternative weight loss and weight management programs.