HealthDay News — The FDA is advising health care providers to monitor patients who take the hyponatremia drug tolvaptan (Samsca, Otsuka) for hepatic injury, after reports of significant liver injury in patients taking the medication.

The FDA and Otsuka notified health care providers of this potential risk after three patients with autosomal dominant polycystic kidney disease (ADPKD) participating in a drug trial developed significant increases in serum alanine aminotransferase, along with significant increases in serum total bilirubin.

The patients were taking a higher dose (90 mg in the morning and 30 mg in the afternoon) than the 60-mg dose approved for hyponatremia. Tolvaptan is not approved for treating of ADPKD.

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An external panel of liver experts determined that tolvaptan was most likely the culprit in these three cases. All of the patients improved once they stopped taking the drug.

“Health care providers should perform liver tests promptly in patients who report symptoms that may indicate liver injury,” the drug maker wrote in a letter to healthcare providers. “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.”