The US Food and Drug Administration (FDA) has issued a warning about the incorrect dosing of the liver disease medicine Ocaliva (obeticholic acid) in some patients, which is resulting in an increased risk of serious liver injury and death.
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Some patients with moderate to severe decreases in liver function are receiving excessive doses of the drug, in particular the FDA states that the frequency of dosing is higher than the recommended level.
Ocaliva is manufactured by Intercept Pharmaceuticals and is used to treat a rare, chronic liver disease known as primary biliary cholangitis (PBC). PBC causes the bile ducts in the liver to become inflamed, damaged and destroyed, resulting in a build-up of bile within the liver, which causes damage to the organ.
In its safety communication, the FDA advises that healthcare professionals determine their patients’ baseline liver function prior to starting treatment. The recommended dosing regimen for patients with moderate to severe liver impairment is to start at 5 mg once a week with an option to increase to 10 mg twice a week. Although, the FDA stresses that careful monitoring of each patient’s condition should be performed and the dosing adjusted should their disease progress and treatment discontinued completely if any sign of liver injury occurs.
Patients are advised by the FDA to report any new or worsening skin itching to their respective healthcare professional. Also, should they encounter any of the following symptoms they should contact their healthcare professional immediately:
- New or worsening fatigue
- Diarrhoea
- Weight loss
- Abdominal pain
- Decreased appetite
- Nausea and vomiting
- Change in behaviour or confusion
- Vague symptoms such as anxiety or unease
- Abdominal swelling
- Yellow eyes or skin
- Bloody stools
The warning follows reports of death and injury submitted to the agency through its Adverse Event Reporting System in the 13 months since Ocaliva was approved. The FDA emphasized that it is working with the drug manufacturer to address the safety concerns.