On January 25th, the FDA announced that the drug Samsca (tolvaptan) “has the potential to cause irreversible and potentially fatal liver injury.”

ISSUE: Otsuka and FDA notified healthcare professionals of significant liver injury associated with the use of Samsca. In a double-blind, 3-year, placebo-controlled trial in about 1400 patients with Autosomal Dominant Polycystic Kidney