The FDA is removing the warning from ambrisentan (Letairis), a pulmonary arterial hypertension drug, that had cautioned that the drug increases the risk for serious liver injury. The agency had mandated monthly liver enzyme tests.
The warning was first issued when the drug was approved in 2007 based on experience with other endothelin-receptor antagonists and a few cases of elevated liver enzymes. FDA analysis indicates that rates of liver problems in patients taking the drug are similar to rates in other patients with pulmonary arterial hypertension.
The boxed warning on the risk of serious birth defects will remain on the label, however.
ARYAN'S BLOG 