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Drugs and Devices

FDA warns of potential risk of liver injury in ADPKD patients taking Samsca

On Jan. 25, 2013, the U.S. Food and Drug Administration notified healthcare professionals of significant liver injury associated with the use of Samsca in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD). In a double-blind, 3-year, placebo-controlled trial in about 1400 patients with ADPKD and its open-label extension trial, three patients treated with the drug developed significant increases in serum alanine aminotransferase (ALT) with clinically significant increases in serum total bilirubin. Healthcare providers should perform liver tests promptly in patients who report symptoms that may indicate liver injury, and if injury is suspected, Samsca should be discontinued. Read more.


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