FDA is sifting through some preliminary data suggesting that Abbott Laboratories' obesity drug Meridia (sibutramine) may carry cardiovascular risks. At this point the operative word is "preliminary;" the agency says it's "making no conclusions about the preliminary findings at this time." Meanwhile, European regulators are also reviewing data from the Scout study, a post-approval trial the EMEA ordered to find out the long-term effects of Meridia on patients at high risk of cardiovascular problems.
Sold in Europe under the names Reductil, Zelium, and Reduxade, Meridia is approved in the U.S. for obese patients who have no history of cardiovascular disease, an Abbott spokesman told Reuters. "Meridia is not approved for 90 percent of patients in the [Scout] study," spokesman Kurt Ebenhoch pointed out. The company is reviewing the data, but doesn't believe the drug's safety profile needs to be changed when it's used in the approved patient population, he said.
This isn't the first time that Meridia's cardiovascular risks have been questioned. In 2005, Consumer's Union petitioned FDA to pull Meridia off the market because of cardiovascular problems. The agency decided that the drug's risks outweighed its benefits and kept it on the market.
It's the first release of data from the Scout study, however. While the study is still being analyzed by Abbott, the company told FDA that patients using Meridia experienced a higher number of cardiovascular events: 11.4 percent of Meridia patients compared with 10 percent of those using placebo. "This difference is higher than expected," FDA notes, "suggesting that sibutramine is associated with an increased cardiovascular risk in the study population." The agency reiterated that the drug shouldn't be used in patients with a history of heart or vascular problems.
- get the FDA's release
- see the coverage from PharmaTimes
- read the Reuters story