Label Changes for:

Letairis (Ambrisentan) Tablets

August 2013

Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2013

 

CONTRAINDICATIONS

Pregnancy
  • Letairis was consistently shown to have teratogenic effects when administered to animals.
 
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