The Business Of Law

Call it food for thought.

The U.S. Food and Drug Administration (FDA) is reviewing the preliminary findings of a new study of the weight loss drug Meridia.  However, the agency recently released an early communication indicating that certain patients taking the drug may have a higher risk of heart attacks, strokes, and other cardiovascular problems. 

Consumer advocacy group Public Citizen last week asked the FDA to ban Meridia because of the study findings.  The group noted that a total of 84 deaths associated with the drug have been reported to the FDA as of June 2009.

The recent study tested sibutramine (sold under the brand name Meridia) in overweight or obese people with an increased risk for heart problems. The analysis of these data is ongoing and FDA was careful to say that it is making no conclusions about the preliminary findings at this time.

That said, the preliminary analysis suggests that patients using sibutramine experienced a higher number of cardiovascular events compared to those using a placebo. The preliminary data shows that cardiovascular events were reported in 11.4% of patients using sibutramine compared to 10% of patients using a placebo. This difference is higher than expected, suggesting that sibutramine is associated with an increased cardiovascular risk in the study population.

The FDA warned that doctors and their patients should continue to follow current guidelines, which recommend against using Meridia in patients with a history of heart-related health issues. As always, the FDA recommends that consumers should talk to their doctor about whether Meridia is right for them.

We at Sokolove Law will be continuing to monitor the FDA’s review of Meridia, and we’ll bring you any further news as it develops.