FDA Panel Split on Whether to Issue Meridia Recall
On September 15, 2010, a U.S. Food and Drug Administration (“FDA”) advisory panel met to determine whether there should be a nationwide Meridia recall. Prompted by recommendations from editors at the New England Journal of Medicine (“NEJM”), a panel of sixteen advisors met to decide whether a Meridia recall should be issued. Although strong evidence suggests that Meridia causes an increased risk of heart attack and stroke, the FDA advisory panel was split on whether to issue a Meridia recall.
Although a Meridia recall has not yet been issued, based on recent medical studies linking use of the popular weight loss drug to an increased risk of heart attack and stroke, the lawyers at Bernstein Liebhard LLP are investigating potential cases against Meridia’s manufacturer and are offering free confidential legal consultations to individuals who believe their heart attack or stroke were a result of Meridia use.
Meridia Recall in Europe
In January 2010, the European Medical Agency issued a Meridia recall for European markets after preliminary results from a clinical trial suggested that patients who used Meridia were more likely to suffer cardiac episodes. Rather than follow suit and issue a Meridia recall in the United States, the FDA instead choose to limit Meridia’s use to patients without prior heart problems.
Findings of NJEM Study Warrant a Meridia Recall
Meridia was first approved by the FDA in 1997. Since its inception, it has been linked to high blood pressure and increased pulse rates. Recent studies have suggested that the risks associated with Meridia’s use are even greater than initially thought. For example, this latest safety review by the FDA was in response to a September 1, 2010 study published in the NJEM. Based on the results of that study, NJEM editors recommended a Meridia recall, and a meeting of the FDA advisory panel was scheduled. During the meeting, members were asked to vote on what additional regulatory action the FDA should take. Options ranged from allowing Meridia to continue being marketed with no label changes to a nationwide Meridia recall. Although the panel did not agree that, as of now, a Meridia recall was appropriate, the entire panel agreed that at the very least, stronger warnings were necessary. Although the panel was split about the drug’s removal from the market, a Meridia recall is still a viable option because the FDA is not required to follow the panel’s recommendations.
Contact a Meridia Lawyer
If you or a loved one experienced a serious side effect associated with Meridia, protect your right to a legal remedy. Contact one of our Meridia injury lawyers and schedule a no-cost consultation. You may be able to file a Meridia lawsuit.