 
Updated Labeling for IBAT Inhibitors Maralixibat and Odevixibat Related to Hepatotoxicity and the Fat-soluble Vitamin Deficiency Sequela of Bleeding
FDA is notifying health care professionals of safety-related changes to the prescribing information for the ileal bile acid transporter (IBAT) inhibitors, Livmarli (maralixibat) and Bylvay (odevixibat). These medications are indicated to treat cholestatic pruritus (persistent itching) in patients with Alagille syndrome (ALGS) or progressive familial intrahepatic cholestasis (PFIC).
Hepatotoxicity (Liver Injury)
When the IBAT inhibitors were first approved, their labeling described liver test abnormalities observed in patients in the initial clinical trials. As additional indications were studied in subsequent trials, evidence emerged of more severe hepatotoxicity. The updated labeling for both maralixibat and odevixibat includes a Contraindication for patients with prior or active hepatic decompensation events (i.e., complications that arise from liver injury such as variceal hemorrhage, ascites, or hepatic encephalopathy). It also includes Warnings and Precautions language describing cases of hepatotoxicity, recommendations for monitoring patients, and guidance for when to discontinue the drugs.
Bleeding
Fat-soluble vitamin (FSV) deficiency occurs in patients with ALGS and PFIC, and the IBAT inhibitors can exacerbate FSV deficiency. FSV deficiency has been described in IBAT inhibitor labeling since the products were approved. With increased patient exposure through clinical trials and postmarket use, there have been more reports of bleeding. The updated labeling for maralixibat and odevixibat expands on the discussion of bleeding as an adverse reaction in the Warnings and Precautions and in the Adverse Reactions sections.
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