Early Communication about an Ongoing Safety Review of Meridia (sibutramine hydrochloride)
This information reflects FDA's current analysis of available data concerning this drug. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available.
[20th Nov 2009] FDA is reviewing preliminary data from a recent study suggesting that patients using sibutramine have a higher number of cardiovascular events (heart attack, stroke, resuscitated cardiac arrest, or death) than patients using a placebo (sugar pill). Sibutramine is marketed as Meridia, a prescription drug, in the United States.
The analysis of these data is ongoing and FDA is making no conclusions about the preliminary findings at this time. These findings highlight the importance of avoiding the use of sibutramine in patients with a history of coronary artery disease (heart disease), congestive heart failure (CHF), arrhythmias, or stroke, as recommended in the current sibutramine labeling.
Meridia (sibutramine 5mg, 10mg, 15mg) was approved by FDA in 1997 for the management of obesity, including weight loss and maintenance of weight loss, in conjunction with a reduced calorie diet. Meridia is only recommended for obese patients with an initial body mass index (BMI) ≥ 30 kg/m2, or BMI ≥ 27 kg/m2 with other risk factors (e.g., diabetes, high cholesterol, controlled high blood pressure).
The study, named the Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT) began in 2002. The analysis of the study results is ongoing by the manufacturer. FDA was made aware of the preliminary results for the study primary endpoint (combination of heart attack, stroke, resuscitated cardiac arrest, or death) in mid November 2009. Part of a post-approval commitment between the European Medicines Agency (EMEA) and the manufacturer, the study was designed to show that weight loss with sibutramine and standard care was more effective in reducing the number of cardiovascular events compared to weight loss from a placebo and standard care.
Patients included in the study 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. Approximately 10,000 patients enrolled in the study.
The preliminary analysis of the primary endpoint suggests that patients using sibutramine experienced a higher number of cardiovascular events compared to those using a placebo. The preliminary data shows that cardiovascular events were reported in 11.4% of patients using sibutramine compared to 10% of patients using a placebo. This difference is higher than expected, suggesting that sibutramine is associated with an increased cardiovascular risk in the study population.
The preliminary study findings highlight the importance of avoiding the use of sibutramine in patients with a history of coronary artery disease (heart disease), congestive heart failure (CHF), arrhythmias, or stroke, as recommended in the current sibutramine labeling. Additionally, healthcare professionals should continue to evaluate the benefits and risks of sibutramine, taking into account individual patient medical histories. Consumers should talk to their healthcare professional about whether sibutramine is right for them.
This early communication is in keeping with FDA's commitment to inform the public about its ongoing safety reviews of drugs. FDA understands the serious nature of the preliminary data and is conducting an expedited safety review. FDA will communicate its findings to the public as soon as this review is complete.
However in January 2010, the European Medicines Agency(EMA) concluded a safety review of Sibutramine and recommended the suspension of marketing authorizations of this product in the European Union as the risks far outweigh the benefits of its use.AMEA Sibutramine suspension recommendation
Source: Food and Drug Administration and European Medicines Agency