Side Effects of Meridia Increases Risk of Heart Attack: Study

A clinical study funded by Abbott Laboratories has concluded that the side effects of Meridia, a weight loss drug, may increase the risk of heart attack and stroke. 

The study’s findings were published this week by the New England Medical Journal, coming just days before an FDA advisory committee is scheduled to review the medication and recommend whether a Meridia recall should be issued. An editorial accompanying the study indicates that there appears to be no good reason to keep Meridia on on the market.

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.

Meridia (sibutramine) was 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.

On September 15, the FDA’s Endocrinologic and Metabolic Drugs advisory committee will review the risks and benefits of Meridia, distributed by Abbott Laboratories. The advisory committee will recommend to the FDA whether the drug should be removed from the market. While the committee’s recommendations are not binding, the FDA usually follows its advice.

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.

In December 2009, the consumer advocacy group, Public Citizen, petitioned FDA to recall Meridia due to the SCOUT trial findings. It is the second time the non-profit has asked FDA to take Meridia off shelves. The first petition, in 2002, was denied by FDA. The drug is listed as a “Do Not Use” drug on the Public Citizen’s “Worst Pills, Best Pills” list.