Abbot Laboratories (Abbot Park, IL) has announced a voluntary withdrawal of its obesity drug Meridia in the United States, according to an FDA announcement made on October 8. The active ingredient in Meridia is sibutramine
Abbot Laboratories (Abbot Park, IL) has announced a voluntary withdrawal of its obesity drug Meridia in the United States, according to an FDA announcement made on October 8. The active ingredient in Meridia is sibutramine.
Approved back in 1997, Meridia has been clinically shown to reduce body weight in obese subjects by 5% compared to diet and exercise alone, but other clinical data suggest the drug is not safe for heart health.
“Meridia’s continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke,” said John Jenkins, MD, director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER). “Physicians are advised to stop prescribing Meridia to their patients and patients should stop taking this medication.”
FDA’s request to pull Meridia is based on evidence recorded in the Sibutramine Cardiovascular Outcomes Trial (SCOUT) in which serious heart health events like non-fatal stroke heart attack and stroke were increased by 16% with Meridia use.
Meridia was banned in Europe in January.
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