Expanded indications/Labeling changes for January 2010

[chantell.reagan]

Expanded indications/labeling changes

Meridia (sibutramine) by Abbott
Labeling change: FDA requested and the manufacturer agreed to add a new contraindication to the sibutramine drug label stating that sibutramine is not to be used in patients with a history of cardiovascular disease, including:

* History of coronary artery disease (e.g., heart attack, angina)
* History of stroke or transient ischemic attack (TIA)
* History of heart arrhythmias
* History of congestive heart failure
* History of peripheral arterial disease
* Uncontrolled hypertension (e.g., > 145/90 mmHg)

•Link to FDA: Follow-Up to an Early Communication about an Ongoing Safety Review

Sources:

U.S. Food and Drug Administration. Drugs@FDA. Available at: Drugs@FDA
U.S. Food and Drug Administration. Center for Biologics Evaluation and Research. Available at: CBER