On Thursday, the Food and Drug Administration (FDA) added tougher warnings to the prescription weight loss medication sibutramine, marketed in the U.S. as Meridia, further highlighting its increased risk of cardiovascular events—heart attack, stroke, resuscitated cardiac arrest, or death—in patients with a history of heart problems. Agency officials say they requested, and Meridia’s manufacturer Abbott Laboratories agreed, to add the new contraindications after reviewing additional data from the Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT) study. However, European regulators took a decidedly harsher stance, advising doctors and pharmacists to stop using sibutramine and recommending that the drug’s marketing license be suspended, saying “the risks of these medicines are greater than their benefits.”
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