FDA Issues Warning for Liver Rx

The US Food and Drug Administration (FDA) is warning that a medication for a rare liver disease could pose deadly risks to some patients.

The FDA issued this warning after the agency received reports of 19 deaths linked to Ocaliva (obeticholic acid) in 13 months. Ocaliva is used to treat a rare type of liver disease called primary biliary cholangitis (PBC).

The agency said some of the deaths and injuries tied to Ocaliva were the result of incorrect dosing. However, the FDA warned that this medication could harm the livers of patients with mild PBC when given in the correct dose.

The FDA and Ocaliva manufacturer Intercept Pharmaceuticals are working to revise the dosing instructions included on the medication's label. In the meantime, the FDA is advising health care professionals of safer dosing regimens.

In addition to the 19 deaths tied to Ocaliva use, the FDA also determined that 11 cases of serious liver injury were tied to the medication. Patients who experience any of the following symptoms should contact their health care providers immediately: skin itching, blood in the stool, yellow skin or eyes, nausea, vomiting, diarrhea, fatigue, weight loss, decreased appetite, stomach swelling and behavioral changes.

The FDA encouraged patients and health care professionals to report adverse events tied to Ocaliva to the FDA MedWatch program.