Ocaliva: Serious Liver Injury
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Intercept Pharmaceuticals Inc.’s Ocaliva (obeticholic acid) was approved by the FDA in May 2016 for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA. Since being on the market here in the US, liver related Ocaliva side effects have drawn scrutiny from the FDA on several occasions.
First, in September 2017, the FDA released a Drug Safety Communication warning of serious liver injury caused by Ocaliva, particularly when the incorrect dosage was given to the patient.
Next, in February 2018, we had this update to the earlier Drug Safety Communication: “FDA adds Boxed Warning to highlight correct dosing of Ocaliva (obeticholic acid) for patients with a rare chronic liver disease“.
Lastly, in May 2020, the FDA started an investigation of Ocaliva side effects involving unspecified “liver disorders”. This ongoing FDA Ocaliva safety evaluation is expected to take about 12 months to complete.
The following side effects may be caused by Ocaliva:
- Liver Injury
- Liver Failure
- Drug-Induced Hepatitis
- Hepatic Failure
- Hepatic Necrosis
- Portal Hypertension
- Hepatorenal Syndrome
We are currently investigating cases of these Ocaliva side effects as possible drug injury lawsuits filed for patients against the responsible drug company — and not your doctor.
Free Ocaliva Case Evaluation
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Most Recent Article About This Drug
Ocaliva-related Liver Injury Warnings Will be Added to Ocaliva Drug Label
We now know more about the Ocaliva-related liver injury “safety signal” that the FDA has been investigating over the past year, and as a result of that Ocaliva FDA safety evaluation there will be an Ocaliva label change with new warnings.
On May 26, 2021, this FDA Drug Safety Communication about Ocaliva, “Due to risk of serious liver injury, FDA restricts use of Ocaliva in primary biliary cholangitis (PBC) patients with advanced cirrhosis”, was issued. This document announced the FDA’s findings of Ocaliva-related liver injury and informed that Intercept Pharmaceuticals Inc. would be adding and updating the Ocaliva Prescribing Information, or drug label.
To read more of this article, click below:
From the May 2021 Ocaliva FDA Drug Safety Communication we get this statement about what the FDA is doing:
We added a new Contraindication, FDA’s strongest warning, to the Ocaliva prescribing information and patient Medication Guide stating that Ocaliva should not be used in PBC patients with advanced cirrhosis. Advanced cirrhosis is defined as cirrhosis with current or prior evidence of liver decompensation (e.g., encephalopathy, coagulopathy) or portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia). We also revised the Boxed Warning, our most prominent warning, to include this information along with related warnings about this risk.
And later in the May 2021 Ocaliva FDA Drug Safety Communication about a “new” Ocaliva-related liver injury and the Ocaliva label change, here is what the FDA found during its Ocaliva liver safety evaluation:
In the five years since Ocaliva’s accelerated approval, FDA identified 25 cases of serious liver injury leading to liver decompensation or liver failure associated with Ocaliva in PBC patients with cirrhosis, both in those without clinical signs of cirrhosis (compensated) or in those with clinical signs of cirrhosis (decompensated). Many of these PBC patients had advanced cirrhosis before starting Ocaliva…. After starting Ocaliva, the pace of the liver decompensation or failure reported suggested these adverse events, which resulted in liver transplant in a small number of cases, were related to the drug rather than progression of the underlying PBC.
We are investigating possible Ocaliva drug injury lawsuits that would be filed against Intercept Pharmaceuticals, the responsible drug company, for patients who have been diagnosed with these serious possible Ocaliva side effects.[Read article in full at original source]
Earlier articles by attorney Tom Lamb on the Side Effects Blog:
- Ocaliva Drug Label Warnings vis-à-vis FDA Ocaliva Safety Signal Investigation
- Current Ocaliva Liver Safety FDA Evaluation Started Back in May 2020
- Ocaliva 2018 Label Change With A Black-Box Warning About Liver Failure
- Ocaliva Patients Died From Liver Injury Says September 2017 FDA Report
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All content by attorney Tom Lamb