Meridia (sibutramine), which was manufactured by Abbott Laboratories, was first approved by the FDA in 1997 as a prescription-only weight loss supplement for obese patients with other risk factors such as diabetes, high cholesterol and controlled blood pressure. In October 2010, the FDA announced that the drug would be recalled due to an increased risk of cardiovascular problems, while providing very little actual weight loss benefit for consumers.
The drug came under FDA scrutiny after clinical trials suggested that Meridia can increase the risk of heart attacks, strokes and other cardiovascular problems. In the wake of the study, called SCOUT, Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of Cardiovascular Event, the FDA announced that they were reviewing potential heart problems from Meridia after SCOUT data suggested that side effects of the drug may cause users to suffer a higher number of cardiovascular events, such as heart attacks, strokes, resuscitated cardiac arrest or death. The European Union issued a Meridia recall in January 2010.
Public Citizen, a consumer advocacy group, said in a press release that the FDA should have heeded its earlier calls for a recall of Meridia. The group first called for Meridia to be banned in 2002, after identifying a growing number of post-marketing cases of heart attacks among relatively young patients with no other explanation. After the FDA denied the 2002 petition, Public Citizen re-petitioned for Merdia to be recalled in December 2009.
“Since (the original 2002 petition), more than 3 million prescriptions have been filled for Meridia, with many patients inevitably having had heart attacks or strokes because of its known toxicity,” said Dr. Sidney Wolfe, Direct of Public Citizen’s Health Research Group. “Even since January of this year (after our December 2009 re-petition to ban the drug), when the European Medicines Agency decided to withdraw the drug from Europe, there have been more than 160,000 prescriptions filled for Meridia in the U.S.”
In 2009, the findings of a clinical trial called SCOUT found that Meridia increased the risk of serious heart events, such as heart attacks and strokes, by 16%, while finding only a small difference in the weight loss between people given Meridia and those given a placebo. The FDA said that the SCOUT data and the agency’s subsequent review led it to the decision to ask Abbott Laboratories to remove Meridia, which it reluctantly has agreed to do.
Researchers looked at 10,744 overweight or obese subjects over the age of 55, who had either a preexisting cardiovascular disease, type 2 diabetes or both. All were put in a weight management program, and about 5,000 were given Meridia and 5,000 were given a placebo. Those given Meridia were shown to have an increased risk of heart attack and stroke, but did not show an increased mortality rate.