A recent FDA MedWatch article noted that the FDA is adding a black box warning to Ocaliva, the only product marketed by Intercept Pharmaceuticals. The drug was incorrectly dosed daily instead of weekly for patients with a rare chronic liver disease. To prevent risk of liver problems, the FDA is clarifying recommendations for the drug with a Boxed Warning.
In the warning, the FDA highlights the heightened risk of liver decompensation or failure if improper dosage is taken. The warning doesn’t ask physicians to limit use of the drug in patients with the disease, but rather to closely monitor patients to watch for declining liver function or progressing cirrhosis.