Atlanta, GAResults from a study of the weight-loss drug Meridia show a connection between increased risk for heart attack and stroke in patients with a history of heart disease who were followed for roughly 3.5 years while taking the drug.
The SCOUT study, reported in the New England Journal of Medicine the first week of September 2010, confirms longstanding concerns about the safety of Meridia when taken by people with heart disease and other heart-related health problems.
The US Food and Drug Administration (FDA) has assembled an advisory committee that will meet later in September to discuss increasing the regulation for the drug. The FDA's action was prompted by initial data from SCOUT, which were released in November 2009.
The study followed 10,744 overweight and obese patients with a history of heart disease or type 3 diabetes and one additional risk factor for heart disease during the nearly four-year follow-up period. The results show that during the follow-up, there was a 4.1 percent incidence of nonfatal heart attack and a 2.6 percent incidence of stroke among patients receiving Meridia.
In a report by CNN.com, lead researcher W. Philip T. James, MD, who is an obesity expert at the London School of Hygiene and Tropical Medicine in the UK, said that the study emphasizes the fact that Meridia should not be prescribed to people with existing heart problems.