Obesity Drug Meridia Pulled for Increased Stroke/Heart Attack Risks
Last week, the FDA announced that Abbott Laboratories is voluntarily removing its popular obesity drug Meridia (sibutramine) from the market because it causes an increased risk of stroke and heart attack in patients taking it.
The stroke and heart attack risks were recently identified in a study published in the New England Journal of Medicine in September.
The FDA requested the company withdraw the drug, after reviewing data from a follow-up study known as the Sibutramine Cardiovascular Outcomes Trial (SCOUT ). It showed there was a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, and death, in a group of patients given Meridia as opposed to others given a placebo.
"In all its investigation of the drug, the FDA could find not one person whose benefit from the drug outweighed its risk," said Dr. Gerald Dal Pan, director of the Office of Surveillance and Epidemiology at the FDA’s Center for Drug Evaluation and Research. –CNN
According to other studies, Meridia’s benefit is that it can help obese people lose 5% or more body weight than obese people who tried to lose weight with diet and exercise only. This comparably small degree of weight loss certainly does not justify the significant increase in stroke, heart attack, and death risks.
It’s gratifying that Abbott Laboratories could make this move voluntarily even in the face of $30 million in projected sales from Meridia. More than 100,000 Americans and 8 million people around the world have been taking this drug to fight obesity. The company has also pulled the drug from the market in Canada.