When the diet drug Meridia was approved by the Food and Drug Administration more than a decade ago, the American Heart Association was quick to urge caution, stressing that the medication—which works in part by curbing appetite by interacting with serotonin, the neurotransmitter that helps regulate the sensation of fullness—might raise blood pressure in some patients, increasing the risk for stroke and heart attack. Now data from a study analyzing the effects of Meridia (sibutramine) on patients with existing cardiovascular health complications, suggests those initial fears may have been warranted. Preliminary analysis from the double-blind, placebo-controlled Sibutramine Cardiovascular Outcomes trial (SCOUT) indicates that, compared with placebo, Meridia increases the risk for heart attack and stroke and in patients with existing heart health problems.
In response to the findings, the European Medicines Agency banned sibutramine, which is sold in Europe under brand names including Reductil and Ectiva. In the U.S., the FDA mandated that Abbott Laboratories, the manufacturer of Meridia, put stronger warning labels on the drug, indicating that it not be given to patients with a history of congestive heart failure, coronary artery disease, stroke, heart arrythmias, uncontrolled hypertension and peripheral arterial disease.
Yet this latest warning highlights a broader issue of trying to find a pharmaceutical solution to the obesity epidemic. As Melissa Healy of the L.A. Times points out:
Unfortunately, there is little else–particularly pharmacological–that has been shown safe and effective for long-term use by the overweight and obese. Currently, the FDA has approved for long-term use only sibutramine and the fat-blocker orlistat–marketed as Xenical and more recently in over the counter form as Alli. For short-term use, it has approved phentermine, diethylpropion and phendimetrazine. A new crop of weight-loss drugs is moving toward FDA consideration in the coming months and years.
The Scout trial followed some 10,000 people with a history of diabetes and/or heart disease over the course of six years. In total, 11.4% of people taking sibutramine suffered a heart attack, stroke or died from cardiovascular complications, compared to 10% of participants taking a placebo.