FDA Issues Safety Alert for Ocaliva

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Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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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:

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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:

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