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FDA’s Safety Review of Sibutramine Warrants New Contraindication Label ROCKVILLE, Md -- January 21, 2010 -- The US Food and Drug Administration (FDA) has reviewed additional data that indicate an increased risk of myocardial infarction and stroke in patients with a history of cardiovascular disease using sibutramine (Meridia). The sibutramine drug label already includes warnings against the use of sibutramine in patients with cardiovascular disease. However, based on the serious nature of the review findings, the FDA requested, and the manufacturer agreed, to add a new contraindication to the sibutramine drug label. The contraindication will state that sibutramine is not to be used in patients with a history of cardiovascular disease, including: · History of coronary artery disease · History of stroke or transient ischaemic attack · History of heart arrhythmias · History of congestive heart failure · History of peripheral arterial disease · Uncontrolled hypertension Healthcare professionals should regularly monitor the blood pressure and heart rate of patients using sibutramine and if sustained increases in blood pressure and/or heart rate are observed, sibutramine should be discontinued. Additionally, sibutramine should be discontinued in patients who do not lose at least 5% of their baseline body weight within the first 3 to 6 months of treatment, as continued treatment is unlikely to be effective and exposes the patient to unnecessary risk. The Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT) study was designed to show that weight loss with sibutramine and standard care was more effective in reducing the number of cardiovascular events compared with weight loss from a placebo and standard care. Patients were aged 55 years or older, overweight or obese, and had a history of cardiovascular disease or type 2 diabetes plus 1 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 November 2009 Early Communication from the FDA described preliminary results from the SCOUT study indicating cardiovascular events occurred in 11.4% of patients using sibutramine compared with 10% of patients using a placebo. This difference was higher than expected, suggesting that sibutramine was associated with an increased cardiovascular risk in the study population. The additional data from the SCOUT study reviewed by the FDA indicate that the increased risk for cardiovascular events with sibutramine occurred only in patients with a history of cardiovascular disease. SOURCE: US Food and Drug Administration E-mail this page to a friend or colleague! To print, use this version