European Union Calls for Meridia Recall and Ban

European Union (EU) medical experts have called for a recall of Meridia, saying that the weight-loss drug’s safety risks outweigh its benefits and that it is too dangerous for public use.

The recommendations by the European Medical Agency’s Committee for Medicinal Products for Human Use came as the FDA warned against use of the drug among patients with heart problems. Marketed as Meridia in the U.S., the sibutramine-based drug is sold in Europe as Reductil, Reduxade, and Zelium. The committee’s recommendations must be approved by the European Commission.

On January 21, the FDA said the drug’s heart risks require that it not be used in patients with a history of cardiovascular disease, such as congestive heart failure, stroke, and hypertension. However, the agency has thus far not indicated whether a Meridia recall will be issued. The consumer group Public Citizen filed a petition with the FDA late last year calling for a Meridia ban, citing additional information from a recent study that found the weight-loss drug may increase the risk of heart attacks, strokes and other cardiovascular problems

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.

In November 2009, the FDA announced that they were reviewing potential heart problems from Meridia after 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 review was announced after FDA began examining data from a 10,000-patient study conducted in Europe known as the Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of Cardiovascular Event (SCOUT). The latest recommendations came after further review of that data.

European medical experts were also consulting the SCOUT data when they came to the conclusion that the drug should be banned.