FDA Warns of Potential Liver Injury For Samsca, Announces Public Meeting

Otsuka America Pharmaceutical Inc. and the Food and Drug Administration Jan. 25 said they have notified health care professionals of significant liver injury associated with the use of Samsca (tolvaptan).

The agency also has scheduled a public conference for March on drug-induced liver injury.

FDA approved Samsca in May 2009 for treating patients with clinically significant hypervolemic and euvolemic hyponatremia, including patients with heart failure, cirrhosis, and the syndrome of inappropriate anti-diuretic hormone (7 PLIR 627, 5/29/09).

In a double-blind, three-year, placebo-controlled trial in about 1,400 patients with autosomal dominant polycystic kidney disease (ADPKD) and its open-label extension ...