FDA considers yanking Meridia from market for cardiac risk factors

Weight loss drug Meridia is under an “ongoing safety review” by the FDA and a panel slated to convene Wednesday is set to discuss whether the medication should be pulled from the market in the US.

Meridia, manufactured by Abbott Laboratories, was pulled from the European market earlier this year amid concerns of adverse cardiac events in patients being treated with the medication. At the time, the FDA bolstered warnings regarding the drug, but stopped short of discontinuing its use in the US. The regulatory body is now weighing whether possible increased risk of “major adverse cardiac events” is worth the potential weight loss benefits seen by patients using the drug:

An FDA clinical review of the study said, “in a population of middle-age and older overweight and obese subjects, treatment with [Meridia] for an average of 3.5 years increased the relative risk for major adverse cardiac events by 16%.” However, the FDA said the data from the study haven’t been fully analyzed.

According to another FDA memo, agency staff said there was evidence that while Meridia improved some cardiac-risk factors, it “may have a detrimental effect on others,” such as an increase in blood pressure and heart rate. Still, the memo said, given the modest decrease in body weight seen with most patients taking Meridia, “even a small increase in cardiovascular risk seems unwarranted.”

Abbott Laboratories supports the inclusion of a “boxed warning,” which is the FDA’s “toughest warning” on a medication. Although the agency generally follows the recommendations of its advisory panel, there is no requirement to pull the drug even if the panel suggests it do so.

[WSJ]