Ocaliva Dosage Errors Prompt the FDA to Require New Black Box Warning

FDA officials have now added a boxed warning label to obeticholic acid (Ocaliva), a liver disease medicine, in order to emphasize the proper dosing patients with rare chronic liver disease should follow.

The FDA announcement states that the designated daily dosage for obeticholic acid, manufactured by Intercept Pharmaceuticals, has been incorrect. Instead, the dosage has been changed to weekly for patients suffering from moderate to severe primary biliary cholangitis (PBC). The former daily dosage increased patients’ risk of liver injury. Adding the boxed warning elucidates the existing recommendations for dosage, screening, managing, and monitoring PBC patients taking Ocaliva. With the modified dosage requirements, patients are also to be given a medication guide that explains dosing problems.

Primary Biliary Cholangitis (PBC)

Most often diagnosed in women in their 40s to 60s, Primary Biliary Cholangitis is a protracted liver disease in which the liver’s bile ducts are destroyed, preventing the flow of bile from the liver to the small intestines – a process which normally helps with digestion. With the bile ducts destroyed, bile can build up and cause damage to the liver over time.

What is Ocaliva?

Manufactured by Intercept Pharmaceuticals, and initially approved in May 2016, Ocaliva is used to treat PBC. Although the drug has been available on the market for two years, it has been associated with 11 cases of serious liver injury and 19 deaths. Seven out of the eight deaths investigated by the FDA involved a worsening condition of PBC. As well, seven of the cases involved patients experiencing moderate to severe declines in liver function after taking the formerly prescribed dosage of 5 mg per day.

The new recommendations reduce the weekly dosage of Ocaliva from 5 mg per day (equal to 35 mg per week) to 10 mg twice weekly (equal to 20 mg per week). Based on the reports of injury and death, the former dosage made Ocaliva into a dangerous drug for many patients.

The FDA initially announced concerns about Ocaliva and liver damage in September 2017.

The FDA now recommends patients taking Ocaliva contact their health provider if they develop or experience any of the following symptoms or conditions:

• Abdominal pain
• Severe itchiness of the skin (either new or worsening)
• Fatigue (either new or worsening)
• Diminished appetite
• Diarrhea
• Yellow skin or eyes
• Nausea and vomiting
• Abdominal swelling
• Weight loss
• Bloody stools
• Confusion, anxiety, or other behavioral changes

The FDA is advising healthcare providers to adhere to the dosing regimen on the new drug label and regularly monitor patients for tolerability, biochemical response, and the progression of Primary Billary Cholangitis. As well, healthcare professionals should reassess the Child-Pugh classification used to identify proper dosing if they are persuaded an adjustment to the dosage is required. According to the recommendations, patients with a risk of deteriorating liver function should be kept under close monitoring.

If the prescription medication you have taken has caused you injury and harm, you may have a valid claim for damages. Our team at McGowan, Hood, Felder & Phillips, LLC wants to help you secure the compensation you deserve, by holding the responsible parties liable. Let’s discuss your case together. To schedule a free, initial consultation, give us a call today at 803-327-7800 or take a moment to request an appointment through our contact form.