FDA Panel Debates Meridia Recall and Stricter Meridia Warning
An independent U.S. Food and Drug Administration (“FDA”) advisory panel met on September 15, 2010 to consider whether the weight-loss drug Meridia should be recalled due to Meridia’s association with an increased risk of heart attack and stroke. The panel considered a range of options, from a nationwide Meridia recall to imposing more stringent Meridia warning requirements.
FDA Panel Split on Recall Versus Stricter Meridia Warning
On September 15, 2010, a 16-member FDA advisory panel met to discuss whether to keep the weight-loss drug Meridia on the market following clinical trials and studies linking the drug to heart attacks and strokes. The panel was split on whether to recommend taking Meridia off the market. Half of the panel voted to recall Meridia and take it off the market. Six panelists recommended keeping Meridia on the market under two conditions: 1) adding in a “black box” Meridia warning label – the most stringent type of warning available, and 2) restricting Meridia’s use. Two panelists recommended unrestricted use with a more stringent Meridia warning requirement. All panel members agreed that a more stringent Meridia warning was warranted. The FDA will consider the advisory panel’s recommendations in making its decision on whether to recall Meridia or impose a stricter Meridia warning.
FDA Continues to Toughen Meridia Warning Standards
The FDA launched a safety review of Meridia in 2009 after preliminary data from a clinical trial known as SCOUT found that Meridia users faced an increased risk of heart problems, while the medication helped them achieve only minimal weight loss. In January 2010, in response to these findings, the FDA toughened Meridia warning standards. In response to the same finding, European regulators removed the product from the market.
The weight loss drug Meridia, manufactured by Abbott Laboratories, was first approved by the FDA in 1997. Early clinical trials revealed that Meridia raised blood pressure and increased heart rate. In response, the FDA required Abbott Laboratories to include a Meridia warning about these risks. Recent clinical trials and studies reveal that the health risks associated with Meridia are even greater than initially identified. A recent study published in The New England Journal of Medicine (“NEJM”) linked Meridia to an increased risk of heart attack and stroke. Based on the studies findings, the NEJM editors recommended taking Meridia off the market. In response to the NEJM editors’ recommendation, the FDA assembled the independent advisory panel on September 15, 2010 to review Meridia’s safety.
Contact a Meridia Lawyer
If you or a loved one has experienced serious side effects associated with Meridia, protect your right to a legal remedy. Contact one of our Meridia injury lawyers and schedule a no-cost consultation.