FDA lifts liver injury risk boxed warning from Gilead's Letairis

FOSTER CITY, Calif. — Gilead on Friday announced that the Food and Drug Administration has removed a boxed warning about a possible liver injury risk caused by the drug maker's hypertension treatment.

Gilead said the FDA approved a change to the prescribing information for Letairis (ambrisentan 5-mg and 10-mg tablets), the company’s once-daily treatment of pulmonary arterial hypertension.

The announcement followed the FDA's review of post-marketing data, which found that during 12-week controlled clinical trials, the incidence of liver function abnormalities was 0% on Letairis and 2.3% on placebo among patients. In conjunction with this label update, PAH patients receiving Letairis no longer are required to obtain monthly liver function tests.

Gilead did note, however, that the drug will continue to carry a boxed warning, since it is contraindicated in pregnancy.