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 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. In the trials the maximum daily dose of Samsca 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.
Although this is a new issue, the lawyers at my firm are investigating whether it will be appropriate to file any Samsca lawsuits on behalf of individuals who suffered liver damage while taking the drug Samsca.
As the news of the association between Samsca and liver injury is less than a week old, there is not a lot of information to go on, yet. But if you’d like to have a Samsca lawyer contact you regarding a potential injury, e-mail me at email@example.com or call toll-free at (855) 452-5529 and we will keep you informed as to what we find.