Ocaliva (obeticholic acid) is a drug manufactured by Intercept Pharmaceuticals for treatment of PBC or primary biliary cholangitis, a rare and chronic disease of the liver that damages the organ as a result of the bile build-up that occurs when the bile ducts become damaged, inflamed, or are destroyed.
Now, the FDA has issued a warning regarding excessive dosing of Ocaliva in patients with moderate to severe decreases in liver function, claiming some who have taken more than the recommended dosage have experienced serious liver injury or even died.
The FDA advises heath care professionals to begin patients with Child-Pugh B and C on a once weekly dosage of 5 mg. PBC patients typically take 5 mg of Ocaliva daily. The FDA further states that patients with moderate to severe liver impairment may have the dosage increased from 5 mg once weekly to 10 mg twice weekly if necessary, although this is the maximum dosage recommended. All patients taking Ocaliva should be closely monitored to determine if injury or damage to the liver is worsening, and if so, discontinue use of the drug.
Ocaliva was approved in May 2016 and since that time, the FDA has learned that several patients have experienced serious liver injury or even death associated with the drug. Anyone with liver problems or who takes Ocaliva and experiences the following symptoms of possible injury should call their health care professional at once.
New or worsening itching of skin
Swelling of, or pain, in the abdominal area
Confusion or other behavioral changes
Skin or eyes that take on yellow tinge
Vomiting or nausea
The FDA is currently working with Intercept Pharmaceuticals to address the safety concerns associated with Ocaliva.
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