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Abbott is complying with FDA's request to withdraw sibutramine (Meridia) from the U.S. market because the obesity drug may pose unnecessary cardiovascular risks to patients, FDA announced.
Abbott is complying with FDA’s request to withdraw sibutramine (Meridia) from the U.S. market because the obesity drug may pose unnecessary cardiovascular (CV) risks to patients, FDA announced.
FDA’s decision to recommend against the use of sibutramine is based on new data from the Sibutramine Cardiovascular Outcomes (SCOUT) trial, which demonstrated a 16% increase in risk of major adverse CV events in patients treated with sibutramine compared to patients who received a placebo. The SCOUT trial was a post-marketing study of approximately 10,000 high-risk patients who were followed for 6 years to evaluate CV risks. FDA had approved sibutramine for the treatment of obesity in 1997.
Although Abbott contended that patients at risk for CV outcomes linked to sibutramine could be identified and CV risks avoided, the SCOUT trial data do not support that assertion, according to FDA’s statement.
“Meridia’s continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke,” said John Jenkins, MD, director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER) in a statement. “Physicians are advised to stop prescribing Meridia to their patients and patients should stop taking this medication. Patients should talk with their healthcare provider about alternative weight loss and weight loss maintenance programs.”
The SCOUT trial included approximately 10,000 men and women aged ≥55 years with a body mass index (BMI) between 27 and 45 kg/m2 or between 25 and 27 kg/m2 with an increased waist circumference. Individuals in the study also had to have a history of CV disease and/or type 2 diabetes mellitus with at least 1 other CV risk factor, such as hypertension, dyslipidemia, current smoking activity, or diabetic nephropathy. The median duration of exposure to the drug was 3.5 years.
The 16% increased risk of CV events included nonfatal myocardial infarction, nonfatal stroke, resuscitation after cardiac arrest, and CV death in the sibutramine group compared to the placebo group. The difference in mean percent of body weight at the end of the 60-month trial between the sibutramine group and the placebo group was about 2.5%.
Data from the SCOUT trial were discussed at the Endocrinologic and Metabolic Drugs Advisory Committee Meeting in mid-September. The public advisory panel of 16 experts selected by FDA reviewed and debated the data. At that time, half the panel experts voted to withdraw the drug from the U.S. market and half voted in favor of greater restrictions (enhanced labeling and risk management strategies).
For more information, patients can consult their physicians or contact Abbott Medical Information by calling 866-257-8909 or visiting www.sibutramine.com.