Reuters Health Information (2011-03-04): FDA removes liver warning from Gilead drug
FDA removes liver warning from Gilead drug
Last Updated: 2011-03-04 13:37:21 -0400 (Reuters Health)
CHICAGO (Reuters) - U.S. health regulators removed warnings about potential liver damage from Gilead Sciences Inc's ambrisentan.
The drug, sold under the brand name Letairis, is a treatment to improve exercise ability and delay clinical worsening in patients with pulmonary arterial hypertension (PAH) and predominantly WHO Functional Class II-III symptoms.
Gilead said PAH patients receiving Letairis are no longer required to get monthly liver function tests.
On its website the company says the FDA decision was "based on its review of post-marketing data reflecting use of Letairis over more than 7,800 patient years.... During 12-week controlled clinical trials, the incidence of liver function abnormalities was 0% on Letairis and 2.3% on placebo."
Because of the risk of birth defects, Letairis continues to have a Boxed Warning.