U.S. Should Ban Diet Drug Meridia, Consumer Group Says

The weight-loss drug Meridia causes increased risks of heart-related complications in users and should be removed from the U.S. market, a leading consumer group told the Food and Drug Administration.

Public Citizen has sent a petition to the FDA asking for Meridia to be withdrawn due to recent international scientific research showing patients taking the drug are at greater risks of suffering potentially deadly cardiovascular complications, according to a Reuters news report.

“The fact that (Meridia) actually increased the number and percentage of cardiovascular events (in the study) … should mandate its immediate removal from the market,” the consumer advocacy group said in a petition filed with the FDA.

Meridia, known generically as sibutramine hydrochloride, is made by Abbott Laboratories Inc. and was FDA approved in 1997 for use in treating obese patients. The prescription drug is used along with reduced-calorie diets in patients who have a body mass index (BMI) greater than 30 or a BMI of greater than 27 along with other risk factors, such as diabetes, high cholesterol, or high blood pressure, the FDA said.

The FDA said last week that preliminary analysis of the study results suggests patients taking Meridia experienced a higher number of cardiovascular events compared to those using a placebo. Cardiovascular events were reported in 11.4 percent of patients using Meridia compared to 10 percent of patients using a placebo, the FDA said.

“This difference is higher than expected, suggesting that sibutramine is associated with an increased cardiovascular risk in the study population,” the FDA said in a statement.

No related posts.