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FDA Issues Warning Against the Use of Ocaliva in Primary Biliary Cholangitis Patients with Advanced Cirrhosis

By Burg Simpson
May 26, 2021
2 min read

The U.S. Food and Drug Administration (FDA) announced that it is restricting the use of Ocaliva in primary biliary cholangitis patients with advanced cirrhosis because it can cause serious harm. Primary biliary cholangitis is a chronic disease that causes the small bile ducts in the liver to become damaged and ultimately destroyed. The destruction of the bile ducts causes bile to remain in the liver, which damages and scars the liver over time. The scarring- called cirrhosis- can affect the liver’s ability to function.

In 2016, the FDA granted accelerated approval for Ocaliva for the treatment of primary biliary cholangitis in combination with another drug – ursodeoxycholic acid (UDCA) – in adults with inadequate response to UDCA alone, or in adults unable to tolerate UDCA. Since Ocaliva’s approval, the FDA reports it has identified 25 cases of serious liver injury, including liver failure, associated with Ocaliva in primary biliary cholangitis patients with cirrhosis. According to the FDA, many of these patients had advanced cirrhosis before starting Ocaliva. Due to these findings, the FDA has added to Ocaliva’s prescribing information a warning that that it should not be used in primary biliary cholangitis patients with advanced cirrhosis.

The FDA recommends that patients with primary biliary cholangitis and cirrhosis who are taking Ocaliva should talk to their health care professionals about the new FDA warning. Additionally, the FDA states patients should contact their healthcare professionals immediately if they develop any symptoms. For more information regarding this FDA announcement, click here.

If you or a loved one has suffered a severe liver injury due to Ocaliva, Burg Simpson’s experienced product liability attorneys can help. Burg Simpson has successfully represented thousands of individuals who suffered injuries due to defective drugs. Burg Simpson’s defective drug lawyers hold pharmaceutical companies responsible for their dangerous drugs, and will fight to secure just compensation for those injured by them. Call Burg Simpson’s Cincinnati attorneys today at 513-852-5600 or fill out our free case evaluation form now to discuss your case with us.

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