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U.S. Department of Health and Human Services

Safety

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Tracleer (bosentan) 62.5 and 125 mg tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 2009

 

Summary View

 

MEDICATION GUIDE (new)

 

REMS Goals

The goals of the Tracleer risk evaluation and mitigation strategy are as follows:
1. To enable informed risk-benefit decisions for treating patients with Tracleer.
2. To minimize the risk of hepatotoxicity in patients who are exposed to
Tracleer.
3. To minimize the risk of fetal exposures in female patients who are exposed to
Tracleer.
4. To educate prescribers, patients, and pharmacies on the safe-use conditions for
Tracleer.