Press Announcements > FDA modifies boxed warning for pulmonary arterial hypertension drug Letairis

FDA modifies boxed warning for pulmonary arterial hypertension drug Letairis
Monthly liver enzyme testing is no longer required

The U.S. Food and Drug Administration today announced that monthly liver enzyme tests are no longer required for those taking Letairis tablets (ambrisentan), used to treat high blood pressure in the vessels that carry blood to the lungs (pulmonary arterial hypertension, or PAH).

Citing data from clinical trials and postmarket reports, the FDA said that the drug poses
only a low risk of liver injury. Information related to potential serious liver injury and the need to monitor for such serious injury is being removed from the drug’s boxed warning.

In patients with PAH, Letairis slows the worsening of symptoms and improves the ability to exercise. Approved in 2007, Letairis is in a class of medications called endothelin receptor antagonists, which stop the action of endothelin, a substance that narrows blood vessels and prevents normal blood flow in those with PAH.

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Press Announcements > FDA modifies boxed warning for pulmonary arterial hypertension drug Letairis