Experts Wonder Why Slimming Drug Meridia (sibutramine) Is Still On The Market In USA

Sibutramine, brand name Meridia is an appetite suppressant, a weight loss pill. Editors at the NEJM (New England Journal of Medicine) write it is difficult for them to discern a “credible rationale for keeping this medication on the market”, even though it is restricted for people without heart disease.

According to a new study, individuals with heart problems have a significantly higher risk of stroke and heart attack if they take Meridia. This confirms concerns about Meridia’s safety for patients with heart disease and other heart problems (they are already warned against taking this prescription medication).

The NEJM article appears a couple of weeks before an FDA (Food and Drug Administration) advisory committee meets to discuss regulatory issues concerning Meridia. The meeting was scheduled after the publication of preliminary results from SCOUT, a study on Meridia released by the FDA in November 2009. In January 2010 the FDA asked Meridia makers, Abbot Laboratories to strengthen the warning on its label.

In January 2010 the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the risks of these medicines (containing sibutramine) are greater than their benefits and recommended the suspension of marketing authorizations for these medicines across the European Union (Link to article).

Put simply, the SCOUT study prompted to Europeans to pull the drug off the shelves, while the FDA asked for stronger warnings only.

In this latest NEJM study, investigators monitored 10,744 obese/overweight individuals who had diabetes type 2 or heart disease and a risk factor, such as hypertension for approximately three-and-a-half years.

The researchers report that:

• 4.1% of the patients on Meridia had a non-fatal heart attack while 2.5% had a stroke.
• 3.2% of those on a placebo had a non-fatal heart attack, while 1.8% had a stroke.

In other words, those on Meridia had a 28% higher risk of having a heart attack and a 36% higher risk of developing a stroke, compared to those on the placebo.

For patients with diabetes type 2, but no history of heart disease or heart problems, Meridia did not appear to raise the risk of stroke or heart attack, the authors report.

There appeared to be no differences in fatalities – deaths from heart attack or stroke – between the patients on Meridia and those on the placebo.

The study supports current recommendations that Meridia should not be given to patients with existing heart disease or problems, the authors write.