FDA to Consider the Future Of Meridia Weight Loss Drug
Carrying extra body weight puts you at risk for several conditions, including diabetes, heart disease and cancer. But for those who are obese and seeking medical treatment, diet pills also carry significant risks. Meridia, one of the few approved diet aids on the market, has been shown in a recent clinical trial to increase the risks of heart attack and stroke.
Both Obesity and Diet Pills Increase the Risks of Heart Disease
The study, called the SCOUT trial and financed by Abbott Laboratories (the maker of Meridia), followed over 10,000 overweight or obese older patients with a mean age of 63. The patients, who had medical histories that included cardiovascular disease, were given Meridia for six weeks. About 940 of the subjects showed immediate problems when placed on the drug and were pulled from the study. The remaining patients either continued taking Meridia or were given a placebo for one year.
Patients on Merdia lost about nine pounds in the first year, compared to four pounds lost by those taking the placebo. However, the Meridia patients suffered 28% more heart attacks and 26% more strokes. For patients without heart disease, according to previous studies, the drug did not appear to increase the risks of either complication.
Meridia (generic sibutramine) works as a neurotransmitter reuptake inhibitor that works outside the cells to stop neurotransmitters from being reabsorbed. This affects the natural chemicals in the brain involved in regulating appetite, allowing them to act longer. Due to feelings of satiety or fullness, patients eat less and therefore lose weight.
Meridia is indicated for use in patients with a body mass index of 30 kg/m2 or more. There is a strong correlation between heart disease and obesity – the more overweight a person is, the more likely he or she is to develop heart disease.
Warnings are issued on the prescribing information for the drug about patients with coronary artery disease. Because the drug can substantially increase blood pressure and/or pulse rate in some patients, those with a history of CAD, uncontrolled blood pressure, congestive heart failure, arrhythmia or stroke should not take Meridia. The drug is also contraindicated for patients over the age of 65.
In an editorial accompanying the study, editors for the New England Journal of Medicine are recommending that Meridia be removed from the US market. . "Nobody got better, and some people got worse, and the amount of weight loss wasn't that much," said The Journal’s executive director Dr. Gregory D. Curfman. "With that profile, we have a lot of difficulty seeing what the argument would be for keeping the drug on the market."
An advisory committee for the US Food and Drug Administration (FDA) will review all clinical data regarding Meridia on September 15th and make recommendations on the fate of the drug in the United States. The drug has already been withdrawn in Europe.
"Effect of Sibutramine on Cardiovascular Outcomes in Overweight and Obese Subjects"
W. Philip T. James, M.D., D.Sc., Ian D. Caterson, M.D., Ph.D., et al.
N Engl J Med 2010; 363:905-917September 2, 2010