Merida Faces European BanJan 22, 2010 | Parker Waichman LLP
The same day U.S. health regulators warned that Meridia (sibutramine) shouldn’t be given to patients with a history of heart problems, their counterparts in Europe said the popular diet drug should be banned. The European Medicines Agency said that sibutramine – sold in Europe under several names, including Reductil, Reduxade and Zelium – should be pulled from the market because of associated risks of stroke and heart attack.
The call for a European ban came after a study of 10,000 patients suggested it put them at a higher risk for heart disease. The study, Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT), was begun in 2002, and involved patients ho were 55 years of age or older, overweight or obese, and had a history of heart disease or type 2 diabetes plus one additional cardiovascular risk factor. Patients who recently had a heart attack or stroke, or had poorly controlled congestive heart failure were not included in the study.
Preliminary data from SCOUT showed that cardiovascular events were reported in 11.4% of patients using Meridia compared to 10% of patients using a placebo. According to the FDA Early Communication issued in November, this difference was higher than expected, suggesting that Meridia is associated with an increased cardiovascular risk in the study population.
Based on the SCOUT findings, the European Medicines Agency found that “the risks of these medicines are greater than their benefits.” Its decision will now get passed to the European Commission for review.
Yesterday, the U.S. Food & Drug Administration (FDA) announced that because of the SCOUT findings, Abbott Laboratories had agreed to add a new contraindication to the Meridia label that it not be used in patients with a history of heart disease, including heart attacks, uncontrolled hypertension and heart-rhythm problems. Previously, the Meridia label only recommended against use of the drug by patients with a history of heart disease.
The FDA also will hold an advisory committee meeting to further discuss the safety and risks with Meridia, after Abbott submits a report on SCOUT. It is expected that the report will be completed in March.