FDA Restricts the Use of Liver Disease Medicine Ocaliva For Risk of Serious Liver Injury
Meyers & Flowers is currently investigating potential Ocaliva chronic liver disease lawsuits for individuals with primary biliary cholangitis (PBC) who have suffered serious liver injuries after taking the drug.
The U.S. Food and Drug Administration recently restricted the use of the liver disease medicine Ocaliva in patients that have primary biliary cholangitis with advanced cirrhosis of the liver because the drug has been found to cause serious harm. Some PBC patients with cirrhosis who took Ocaliva, especially those with evidence of advanced cirrhosis, developed liver failure – sometimes requiring liver a transplant.
In response, the FDA is adding a new contraindication, the agency’s strongest warning, to the drug’s labeling information and patient education guide stating the drug should not be used by PBC patients with advanced cirrhosis.
What is Ocaliva?
Ocaliva (obeticholic acid) is an oral tablet used to lower the level of liver enzyme that is found in the blood, and that is elevated in PBC patients who have not responded well enough to another medicine called ursodeoxycholic acid (UDCA). With no generic equivalent, patients rely on Ocaliva to treat primary biliary cholangitis, which is a rare autoimmune disease affecting the small bile ducts in the liver that become inflamed, damaged, and destroyed. Consequently leading to liver failure, cirrhosis (late stage of scarring of the liver), and death.
Why did the FDA Restrict the Use of Ocaliva?
The medication was approved in 2016 on an accelerated basis with the condition that its manufacturer Intercept Pharmaceuticals, Inc. would continue to undergo testing and clinical studies to identify all known side effects and risks. In these five years since, the FDA has identified 25 cases of serious liver injuries leading to liver decompensation or liver failure in users with cirrhosis. Among the 25 cases, four patients with compensated cirrhosis required a liver transplant within little over a year of starting use of Ocaliva. One user with cirrhosis died of liver failure.
All of these cases described PBC patients with cirrhosis taking Ocaliva at the recommended dosage prior to the initial liver-related adverse event. The reports highlighted in the new warning only depict those submitted to the agency and those found in medical literature, so there may be numerous other incidents which we are unaware of.
The FDA’s Past Concerns About Ocaliva
The regulator’s new contraindication follows a series of prior reports. The FDA first raised concerns in 2017 as they alerted consumers about the serious complications associated with Ocaliva in a Drug Safety Communication. The emergency health letter notified that 19 patients taking Ocaliva had died and at least 11 others were discovered to have developed liver disease. The adverse effects were partially attributed to users receiving excessive dosing, resulting in an increased risk of serious liver injury and death. The statement also warned that patients with a milder form of PBC may experience liver injury even when receiving the correct dose.
Later in 2018, a black box warning was issued on the label and medication guide to correct the prescribing and dosage information, as severe adverse events were reported in patients after being incorrectly dosed daily instead of weekly. The new Boxed Warning, the FDA’s most prominent warning, updated the recommendations for screening, dosing, monitoring, and managing PBC patients with moderate to severe liver disease.
Contact Meyers & Flowers Today
If you or a loved one believe you have been harmed by Ocaliva, contact our experienced legal team to get the help you deserve. At Meyers & Flowers, our track record of large resolutions for victims of dangerous drugs is a testament to the representation you will receive. With no fees unless we win, contact us today for a free case evaluation at (630) 232-6333, [email protected] or on our website.