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    Agency Releases Early Communication on Possible Heart Risks

    Nov. 23, 2009 -- A new study of the weight loss drug Meridia is in the hands of FDA regulators, who've released an early communication based on preliminary data: certain patients taking the drug may have a higher risk of heart attacks, strokes, and other serious cardiovascular problems.

    The recent study tested Meridia (sibutramine) in overweight or obese people with an increased risk for heart problems. The agency warned that doctors and their patients should follow the current guidelines, which recommend against using Meridia in people with a history of coronary artery disease, congestive heart failure, heart rhythms disorders called arrhythmias, or stroke.

    The FDA will continue to review findings from the SCOUT study, which was designed to test whether Meridia could help prevent heart problems by helping overweight and obese people lose weight. The FDA isn't making any conclusions about the early findings at this time. Analysis of the study's findings is ongoing.

    European investigators followed about 10,000 people, age 55 or older, who had a history of heart disease or type 2 diabetes and one additional risk factor for heart disease. Half got sibutramine along with standard medical care for five years, while the other half took a sugar pill (a placebo) and got standard medical care. Serious cardiovascular events occurred in:

    • 11.4% of people taking Meridia
    • 10% of patients taking a sugar pill

    A spokesman for Abbott Laboratories, the maker of sibutramine, says Meridia is safe when used in the appropriate group of people, as prescribed. According to Kurt Ebenhoch, the SCOUT study looked at high-risk patients who took the drug much longer than the one-year maximum use recommended in the U.S. "Sibutramine is not recommended or approved for use in more than 90% of the patients in the SCOUT study," Ebenhoch says.

    Meridia works in the brain to help people feel full with less food. It's approved for use by obese people with a BMI (body mass index) of 30 or higher along with a weight loss diet and regular exercise. It's sometimes prescribed for people with BMIs as low as 27 when they have a weight-related condition like diabetes or sleep apnea.

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