A Panel Divided: FDA Advisory Group Splits on Meridia Decision
An advisory panel for the FDA met yesterday to decide whether there is sufficient evidence of health risks that would warrant the removal of the weight loss drug Meridia (sibutramine) from the US market. In its final decision, the panel split down the middle – eight members voted to pull the drug while eight felt it should remain available, but with renewed warning labels.
All FDA Advisory Panel Members Voted for Restrictions on Meridia
Meridia was first approved in the US in 1997 and is available only by prescription. Like many medical treatments for weight loss, the drug has serious side effects, including an increased risk of cardiovascular events such as stroke or heart attack. The large SCOUT released in November of last year found that people who took Meridia had an 11% risk of cardiovascular events while those taking a placebo had a 10% risk.
Meridia also raises blood pressure and heart rate.
Obesity in itself is a risk factor for cardiovascular disease. Warnings on the prescribing label indicate that Meridia is not to be used in patients with existing heart disease, but experts were troubled because of the large number of patients with undiagnosed conditions. The National Institutes of Health suggested in 2006 that as many as three million women in the US might have a condition that places them at a higher risk of heart attack, yet are not aware.
Eighty percent of Meridia users are middle-aged women.
Those on the panel that oppose the continuation of Meridia on the US market feel that the risks of the drug outweigh the potential benefits. The average patient who responds to the drug loses 4% more body weight than what they might lose with a placebo – an amount considered a modest benefit.
"The question has always been, of these competing forces, which ones will win out in terms of cardiovascular risk?" says Eric Colman, MD, deputy director of the FDA's Office of Metabolism and Endocrinology Products.
The drug has been removed from the European market, and the panel decision will be put before the FDA to decide on the ultimate fate of Meridia. Although the FDA does not always follow advisory panel recommendations, it usually does.
Abbott Laboratories, which manufactures Meridia, had pledged step up warnings and educational efforts for doctors and patients if the drug is allowed to stay on the market.