Abbott Laboratories' (NYSE: ABT) weight-loss drug Meridia will get a day in court--FDA court, that is. An FDA advisory panel will review the drug Sept. 15, analyzing data on Meridia's safety risks. The review comes months after European regulators prompted Abbott to withdraw the diet pill from that market.
At issue is relatively new data that indicated a higher risk of cardiovascular troubles in patients using Meridia, Pharmalot reports. The SCOUT trial of 10,000 patients compared Meridia with placebo, finding increased risk of serious CV problems, such as stroke or heart attack.
After the data appeared, the European Medicines Agency first told doctors to stop prescribing the weight-loss pill, but eventually recommended that the European Commission suspend Abbott's marketing clearance for the product. The company then voluntarily pulled Meridia off the European market.
Meanwhile, the FDA took a softer approach. It asked Abbott to add stronger warnings to Meridia's label, saying that the pill shouldn't be used by patients with a history of cardiovascular disease. But now, the drug will get a hearing before agency's expert advisors.