|WASHINGTON — The FDA said the weight-loss drug sibutramine (Meridia) should not be taken by patients with history of cardiovascular disease following a review of additional data showing an increased risk of heart attack and stroke among that population.
The agency said the manufacturer, Abbott, has agreed to add the contraindication to its labeling, which will be expanded to include patients with a history of the following:
- Coronary artery disease (i.e., heart attack, angina)
- Stroke or transient ischemic attack
- Heart arrhythmia
- Congestive heart failure
- Peripheral arterial disease
- Uncontrolled hypertension (>145/90 mmHg)
The initial review of sibutramine began in November 2009 when the FDA received preliminary data from the SCOUT study suggesting patients using the drug had a higher risk for cardiovascular events. (See Early Data Link Diet Drug to MI, Stroke, and Cardiac Death)
Prior to review, the product label included a warning for patients with cardiovascular disease.
Healthcare professionals should monitor patients for increase in blood pressure and heart rate and should discontinue therapy if either increase is observed, an FDA statement said.
Patients should also discontinue use of sibutramine if they do not lose 5% of their baseline body weight within the first three to six months of treatment, as the drug may not be effective and puts the patient at unnecessary risk, the release said.
The FDA said its review of SCOUT study data, as well as other information related to the drug’s risks and benefits, is ongoing and will be followed by an open public advisory committee meeting to determine if it requires additional regulatory action.