FDA is alerting healthcare professionals that Meridia (sibutramine) is contraindicated in patients with a history of cardiovascular disease because the drug increases their risk of heart attack and stroke. Meridia is used to manage obesity.

In November 2009, an early communication from FDA reported preliminary study results suggesting that patients on Meridia had a greater frequency of cardiovascular events than those not taking the drug. Additional data from the study has shown that the excess risk occurred in patients with a history of cardiovascular disease.

Based on this information, Meridia is now contraindicated in patients with a history of cardiovascular disease, including coronary artery disease, stroke or transient ischemic attack (TIA), cardiac arrhythmias, congestive heart failure, peripheral arterial disease, or uncontrolled hypertension. Healthcare professionals should regularly monitor the blood pressure and heart rate of patients using Meridia and discontinue the drug if there are sustained increases in these measurements.

They should also discontinue Meridia in patients who do not lose at least 5 percent of their baseline body weight within the first three to six months of treatment, because further treatment is not likely to be effective and exposes the patient to unnecessary risk. Patients using Meridia should talk with their healthcare professional about whether to continue using the drug.