Label Changes for:
Promacta (eltrombopag) tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – March 2010 and February 2011
WARNINGS AND PRECAUTIONS
- Thrombotic/Thromboembolic Complications
High platelet counts and higher chance for blood clots
- You may have a higher chance of getting a blood clot if your platelet count is too high during treatment with Promacta but blood clots can occur with normal or even low platelet counts. You may have severe complications or die from some forms of blood clots, such as clots that travel to the lungs or that cause heart attacks or strokes. Your healthcare provider will check your blood platelet counts, and change your dose or stop Promacta if your platelet counts get too high. Tell your healthcare provider right away if you have signs and symptoms of a blood clot in the leg, such as swelling, pain, or tenderness in your leg.