The Food and Drug Administration (FDA) is warning that excessive dosing of obeticholic acid (Ocaliva), a drug approved to treat primary biliary cholangitis, may increase the risk of liver damage and could potentially be fatal. Primary biliary cholangitis is a rare chronic liver disease in which the bile ducts are inflamed, damaged, and destroyed, causing a buildup of bile in the liver that leads to loss of liver function.

The dosing recommendations for obeticholic acid vary based on the patient's liver function. Between May 2016, when the drug was approved, and June 2017, the FDA received reports of 19 deaths associated with obeticholic acid, and 11 cases of serious liver injury. In many of these case reports, the patients had been diagnosed with moderate-to-severe liver impairment but were receiving the dose recommended for patients with zero-to-mild liver impairment (patients with worse liver impairment need a lower dose than patients with milder liver impairment). Some case reports also showed liver function deterioration in patients with no or mild liver dysfunction.

Nurses and NPs who work with patients prescribed obeticholic acid for primary biliary cholangitis should confirm that the patients are taking an appropriate dose based on their identified phase of liver impairment. Patients with moderate-to-severe liver impairment (Child-Pugh B and C) should be started on the approved dosing schedule of 5 mg once weekly, rather than the schedule of 5 mg daily, which is appropriate for patients with less severe disease. Providers should monitor patients frequently for disease progression and reduce the dosing frequency to once or twice weekly in patients whose mild impairment progresses to moderate-to-severe impairment. Nurses should also teach patients about the symptoms of deteriorating liver function and tell them to report these symptoms to the prescriber as soon as possible.

To read the FDA Drug Safety Communication regarding obeticholic acid, go to http://www.fda.gov/Drugs/DrugSafety/ucm576656.htm.