Europe Bans Meridia Diet Pill; FDA Strengthens Warning

On January 21, 2010, the U.S. Food and Drug Administration (FDA) issued an additional contraindication for sibutramine, marketed as the weight loss medication Meridia, following the review of study data from the SCOUT (Sibutramine Cardiovascular OUTcomes) clinical trial. The same data, which showed an increased risk of heart attack, stroke, and other cardiovascular problems in those taking sibutramine, prompted the European Medicines Agency (EMEA) to suspend all sales of medications containing sibutramine, including Meridia.

The SCOUT trial, which began in 2002, studied 10,000 patients with a history of cardiovascular disease or type 2 diabetes who were taking sibutramine to lose or manage weight. The study was designed to investigate if long-term treatment with the diet drug could reduce the risk of serious cardiovascular conditions typically associated with overweight and obese patients. However, results showed a greater risk of heart attack, stroke, and other cardiovascular problems in those taking sibutramine compared with those taking a placebo.

Last week, the EMEA advised doctors and pharmacists to stop prescribing and dispensing Meridia and other sibutramine medications including Ectiva, Reductil, Reduxade, and Zelium, citing that, “the risks of these medicines are greater than their benefits.” Although sibutramine was already contraindicated in patients with a history of cardiovascular disease, the EMEA believed that all overweight and obese patients could be affected, as they are likely to be at risk for cardiovascular disease.

Upon review of the SCOUT study data, the U.S. FDA asked Abbott Laboratories, the manufacturer of Meridia, for a stronger warning label, including a contraindication for patients with a history of heart attack, stroke, heart arrhythmias, congestive heart failure, peripheral artery disease, coronary artery disease, or uncontrolled high blood pressure.

While many doctors and researchers agree with Europe’s decision to completely ban sibutramine based on potential health risks, others support the FDA’s decision to keep sibutramine medications on the market.

Dr. Louis Aronne, director of the weight control program at New York-Presbyterian/Weill Cornell Medical Center, agreed with the FDA decision, explaining, “Running up the hill might increase your risk of having a heart attack if you have coronary disease,” said Dr. Aronne. “But if you are 23 years old and have no coronary disease, then running up the hill can prevent you from getting heart disease.”

Meridia, approved by the FDA in 1997, is a weight loss medication and appetite suppressant prescribed for patients with a body mass index (BMI) of 30 or higher, or in those with a BMI of 27 or higher in the presence of risk factors such as high blood pressure, type 2 diabetes, high cholesterol, or a large waist circumference. Clinical trials with Meridia have shown an average of 10 to 14 pounds lost within a year.

A Schedule IV controlled substance under the U.S. Controlled Substances Act, sibutramine increases the body’s metabolism and is known to raise heart rate and blood pressure. Earlier this month, the FDA issued a warning for consumers concerning counterfeit Alli weight loss pills, citing that the counterfeit version contained sibutramine and could be potentially harmful if taken unknowingly by patients with cardiovascular disease.

Additional information about drugs and drug side effects may be found on Drugwatch.com.