FDA: Sibutramine Is Contraindicated in Heart Patients

Patients with histories of cardiovascular disease who are using the weight-loss drug sibutramine (Meridia) face increased risks for MI and stroke, the FDA has concluded as part of its ongoing safety review. Accordingly, the agency is calling for a stronger warning on the drug's label.

The prescribing information currently warns against sibutramine's use in patients with CVD. With the revision, the warning will become a contraindication and will state that the drug should not be used in patients with histories of:

• coronary artery disease, including MI and angina

• congestive heart failure

• arrhythmia

• stroke or transient ischemic attack

• peripheral arterial disease

• uncontrolled hypertension