Meridia Panel Split on BanSep 16, 2010 | Parker Waichman LLP
Eight members of a Food & Drug Administration (FDA) advisory committee have called for Meridia to be pulled from US market. Six others on the 16-member panel favored restrictions on prescribing the weight loss drug, while the remaining two members voted to add a new black box warning to the Meridia label highlighting its association with heart attacks and strokes.
The FDA generally follows the advice of its outside panels, but it is not required to do so. It’s difficult to gauge what the agency will do about Merida, considering the committee’s divided vote yesterday.
Of note, when Meridia was approved for use in the US 13 years ago, the majority opinion of FDA’s outside advisers had opposed it because of its potential for heart problems. The drug is currently contraindicated for use in patients with a history of heart problems.
The FDA began a safety review of Meridia after a large study released last November found that people who took the drug had an 11 percent risk of cardiovascular events, while those who took a placebo had a 10 percent risk. That study, called Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT), has already prompted European regulators to remove Meridia from the market there. The study followed about 10,000 patients with a history of cardiovascular problems.
The FDA has received reports of 14 deaths linked to the use of Meridia. Patients who died were 43 years old, on average, and 71% were women.
In general, patients taking Meridia lose around 4 percent more weight than those taking a placebo. Critics question whether or not this modest result is worth the risks posed by the drug.
“We do make the assumption that weight loss is beneficial and that it translates into clinical benefits, but we’re not presented with those here,” said Dr. Katherine Flegal, of the Centers for Disease Control and Prevention. “On the whole, there are not the benefits that justify the risks.” Flegal was among the panel members who favored pulling Meridia from the market.
It is not known when the FDA will make a final decision on the fate of Meridia.