FDA committee split on keeping Abbott's Meridia on market
Sibutramine is approved for weight loss in patients who are either obese or overweight, and have no previous history of cardiovascular disease. The 10,744-patient, six-year SCOUT study, which was requested by European regulatory authorities as a post-marketing commitment, found that patients with a history of cardiovascular conditions treated with sibutramine saw an increased risk of MI and nonfatal stroke, but not cardiovascular death. The study was published in the New England Journal of Medicine.
In November 2009, FDA warned that the drug could lead to an increased risk of cardiac events in patients. Then, in January, with additional data, the FDA warned that there is an increased risk of heart attack and stroke in patients with a history of cardiovascular disease using sibutramine, contraindicating the drug for these patients.
Eugene Sun, MD, vice president of Abbott's global pharmaceutical development, said, "Today's vote highlights the complexity of this scientific debate. We continue to believe that there are appropriate and identifiable patients that derive benefit from sibutramine.… Abbott has proposed comprehensive risk management tools to ensure that physicians and patients have the most relevant information for the continued appropriate use of sibutramine.
"Sibutramine has been studied in more than 100 clinical trials involving more than 20,000 patients, in addition to those involved in the SCOUT study," said Sun. "SCOUT did not directly assess the risk/benefit profile of the medication in patients for whom it is specifically intended and its results cannot be readily extrapolated to the approved patient population, that is, patients who do not have a history of cardiovascular disease."
The FDA will now consider the recommendation of the Endocrinologic and Metabolic Drugs Advisory Committee.