On January 21, 2010, the day that U. S. 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 who 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.
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:
• History of coronary artery disease (e.g., heart attack, angina)
• History of stroke or transient ischemic attack (TIA)
• History of heart arrhythmias
• History of congestive heart failure
• History of peripheral arterial disease
• Uncontrolled hypertension (e.g., > 145/90 mmHg)
Meridia is a drug that is typically prescribed to patients with a history of obesity or being overweight. This particular patient population is at a greater risk of cardiovascular events. If you or a family member has suffered a heart attack, stroke or cardiovascular event while on Meridia, please call an attorney with McGowan, Hood and Felder today at 877-327-3800 (toll free). We offer all potential clients a free consultation to assist them in determining their legal rights. Call us today to determine your rights in regard to Meridia.
To discuss your case and how we can help you, contact McGowan, Hood & Felder, LLC today.
