Ocaliva Lawsuit
Ocaliva Linked to Serious Liver Injury in PBC Patients Without Cirrhosis
Ocaliva Linked to Serious Liver Injury
The U.S. Food and Drug Administration (FDA) has issued a critical safety communication regarding Ocaliva (obeticholic acid), a medication used to treat primary biliary cholangitis (PBC). The FDA has identified cases of serious liver injury among PBC patients taking Ocaliva who do not have cirrhosis. In a postmarket clinical trial, patients receiving Ocaliva demonstrated a higher risk of liver transplant and death compared to those on a placebo. To ensure patient safety, frequent liver test monitoring is essential to detect worsening liver function and determine if discontinuation of Ocaliva is necessary.What is Ocaliva?
Ocaliva (obeticholic acid) is a medication used to treat primary biliary cholangitis (PBC), a chronic liver disease. It is a farnesoid X receptor (FXR) agonist that works differently from other PBC treatments by activating FXR in the liver, which plays a critical role in bile acid regulation. Ocaliva is typically prescribed in combination with ursodeoxycholic acid (UDCA) for adults with an inadequate response to UDCA alone, or as monotherapy for those unable to tolerate UDCA. The drug has been shown to reduce alkaline phosphatase levels, a marker of liver dysfunction, and may help slow the progression of PBC.
What is Primary Biliary Cholangitis (PBC)?
Primary Biliary Cholangitis (PBC), formerly known as primary biliary cirrhosis, is a chronic, progressive liver disease that primarily affects women between the ages of 35 and 70. It is characterized by inflammation and destruction of the small bile ducts within the liver, leading to the buildup of bile and eventual liver damage. PBC is believed to be an autoimmune condition, where the body’s immune system mistakenly attacks its own bile ducts. Over time, this can result in scarring of the liver (cirrhosis), liver failure, and other complications.