The FDA and drug manufacturer Otsuka are notifying healthcare professionals of “significant” liver injury associated with the use of the drug Samsca. The agency is urging clinicians to conduct liver tests promptly in patients who report symptoms that may indicate liver injury.
Three participants in a large study of patients with autosomal dominant polycystic kidney disease who were treated with the drug “developed significant increases in serum alanine aminotransferase (ALT) with concomitant, clinically significant increases in serum total bilirubin.” On discontinuation of treatment, all three patients improved, said the agency. An external panel that reviewed the cases concluded that the issues were “probably or highly likely to be caused by tolvaptan.” According to the FDA, these findings indicate that Samsca (tolvaptan) has the potential to cause irreversible and potentially fatal liver injury.
Samsca is a selective vasopressin V2-receptor antagonist indicated for the treatment of hyponatremia (low blood sodium levels). Samsca is not approved for the treatment of ADPKD.
The FDA is recommending that healthcare providers perform liver tests promptly in patients who report symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice. If hepatic injury is suspected, Samsca should be promptly discontinued, appropriate treatment should be instituted, and investigations should be performed to determine probable cause. Samsca should not be re-initiated in patients unless the cause for the observed liver injury is definitively established to be unrelated to treatment with Samsca.
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