FDA warns of liver injury risk with tolvaptan

Source: BioSpace , FDA Area: News The FDA and Otsuka America Pharmaceuticals have notified healthcare professionals of significant liver injury associated with the use of tolvaptan. In a double-blind, 3-year, placebo-controlled trial in about 1400 patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) and its open-label extension trial, 3 patients treated with the drug developed significant increases in serum alanine aminotransferase (ALT) with concomitant, clinically significant increases in serum total bilirubin. Most of the liver enzyme abnormalities were observed during the first 18 months of therapy. In the trials the maximum daily dose of tolvaptan administered (90 mg in the morning and 30 mg in the afternoon) was higher than the maximum 60 mg daily dose approved for the treatment of hyponatremia.
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news