On September 21st, the FDA issued a drug safety communication for Ocaliva (obeticholic acid), a medication used to treat primary biliary cholangitis (PBC).
The FDA warns that using Ocaliva can cause serious liver injury and even death when improperly dosed. The FDA has reviewed the 19 cases of death potentially caused by Ocaliva, and determined that in several cases patients with moderate to severe liver disease were receiving too high of a dose. This can result in an increased risk of serious liver injury or death.
What is Ocaliva indicated for?
Ocaliva is indicated in adults for the treatment of primary biliary cholangitis (PBC) with or without ursodeoxycholic acid.
Primary biliary cholangitis (PBC) is a rare liver disease in which your body begins to attack itself and destroy the bile ducts in the liver, leading to liver damage or eventual cirrhosis.
What are the signs and symptoms of associated with liver function?
If you or someone you know is taking Ocaliva, be sure to seek medical attention for the following signs and symptoms:
- New or worsening tiredness
- Weight loss
- Stomach pain
- Decreased appetite
- Nausea and vomiting
- change in behavior or confusion
- Anxiety or unease
- Stomach swelling
- Yellowing of the eyes or skin
- Bloody stool
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What is being done to warn people about these serious side effects?
The FDA is reminding healthcare providers to determine patients’ baseline liver function before starting a patient on Ocaliva.
What does the FDA recommend prescribers do?
The FDA recommends the following:
- Patients with moderate to severe liver impairment should be started on the approved dosing schedule of 5 mg once weekly, rather than the 5 mg daily dose.
- Healthcare professionals should monitor patients frequently for disease progression, and reduce the dosing frequency for patients who progress to moderate or severe liver impairment.
- All patients treated with Ocaliva should be monitored frequently for liver injury (e.g. worsened liver blood tests and adverse liver-related reactions).
- If liver injury is suspected, discontinue Ocaliva.
- After the patient has stabilized, weigh the benefits against the risks when deciding whether to re-initiate treatment. Educate patients about the symptoms of potential liver injury.