Rockville, MDAlthough Meridia has been pulled from the market due to the risk of serious Meridia side effects, consumers could still be exposed to Meridia-related side effects. Meridia is known generically as sibutramine, and the US Food and Drug Administration (FDA) has created a list of weight loss products that contain sibutramine and could therefore put patients at risk of serious side effects.
Sibutramine could still be available on the market because FDA does not regulate products categorized as dietary supplements, and many weight loss products are marketed as dietary supplements. These products should still have been submitted to the FDA for approval, however, because they contain sibutramine, which is an FDA-approved drug and is not a dietary supplement. Unfortunately, not all companies follow the rules, so products that contain sibutramine can still make their way onto the marketplace.
Even though Meridia (the brand name of sibutramine) has been pulled from the market, dietary supplements that contain sibutramine could still be available, and could potentially harm consumers. Although the FDA tries to keep such products off the US marketplace, the agency acknowledges that it is impossible to test and identify all products that contain prescription drugs.
In 2009, the FDA requested recalls of known dietary supplements that contained sibutramine, including 2 Day Diet, 2 Day Diet Slim Advance and many others. According to an FDA FAQ (04/20/09), some dietary supplements contain up to three times the recommended daily dosage of sibutramine. At levels that high, even patients with no history of health problems could suffer serious sibutramine side effects, including increased blood pressure, tachycardia and seizure.
Patients at highest risk of serious sibutramine side effects include patients with a history of hypertension, seizure or coronary artery disease and patients taking any medication that could negatively interact with sibutramine. Those medications include MAOIs, lithium, sumatriptan and fentanyl.
In October 2010, the FDA announced that it was recommending against continued use of Meridia because of potentially unnecessary risks to patients, including serious cardiovascular risks. The recommendation followed the release of data from the Sibutramine Cardiovascular Outcomes (SCOUT) trial, which showed a 16 percent increase in the risk of major adverse cardiovascular events in patients who were treated with Meridia as compared with patients who were given a placebo.
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