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Sibutramine Use Contraindicated in Patients With History of CVD, Says FDA Full Text
American Family Physician, 01/27/2010
The FDA is informing physicians and patients about the increased risk of heart attack and stroke in patients with a history of cardiovascular disease who use the prescription weight–loss drug sibutramine hydrochloride. The FDA said the contraindication will state that sibutramine should not be used in patients with a history of cardiovascular disease, including: coronary artery disease (myocardial infarction, angina); stroke or transient ischemic attack; heart arrhythmias; congestive heart failure; peripheral arterial disease; or uncontrolled hypertension. Physicians should regularly monitor the blood pressure and heart rate of patients using sibutramine. If sustained increases in blood pressure and/or heart rate are observed, use of the drug should be discontinued. Weight–loss medication should be discontinued in patients who do not lose at least 5 percent of their baseline weight within the first three to six months of treatment because continued use is unlikely to be effective and exposes patients to unnecessary risk.