Diet Drug Meridia is Withdrawn from US Market
If you are among the 100,000 Americans who has been taking Meridia (sibutramine), it’s time to lose your appetite for the diet drug. Abbott Laboratories, makers of Meridia, has voluntarily withdrawn their product from the US market.
Meridia has been associated with strokes and heart attacks
Meridia was approved in 1997 in the United States even though there was pre-approval evidence of increased blood pressure and heart rate among study participants. Initially the drug sold well, but when safety concerns were raised in 2002, sales began to decline. From the 1.3 million prescriptions issued in 1998, a mere 250,000 were written in 2009.
Back in 2002, the national nonprofit consumer advocacy organization Public Citizen petitioned the Food and Drug Administration (FDA) to ban the weight loss drug, citing concerns over an increased risk of stroke and heart attack in some patients. The FDA refused the request, stating that the drug’s “overall risk-benefit profile supports it remaining available as a prescription drug for the treatment of appropriately selected obese patients.”
In September 2010, a study in the New England Journal of Medicine reported that patients who took Meridia had a 28 percent higher risk of having a heart attack and a 36 percent greater risk of developing a stroke when compared to individuals on placebo. The study patient population consisted of 10,744 obese/overweight men and women who had type 2 diabetes or heart disease and a risk factor.
According to Abbott, Meridia is designed for individuals who need to lose 30 pounds or more, and it should be used along with a reduced-calorie diet. Now the FDA has decided that the drug’s “very modest weight loss” benefit does not outweigh the risk of stroke and heart attack.
Although Abbott has complied with the FDA’s request to withdraw Meridia from the US market, it disagrees with the agency’s conclusions about the drug’s risks. The European Union stopped sales of the diet drug in January 2010, and regulators in Canada and Australia had withdrawn the drug previously as well.
Food and Drug Administration