Black Box Warning Added to Ocaliva
February 1, 2018 – The U.S. FDA has added a black box warning, its strongest precaution, to the labeling for Intercept Pharmaceuticals’ Ocaliva® (obeticholic acid). The warning has been added due to concerns that the drug is being incorrectly dosed in patients who have moderate to severe primary biliary cholangitis (PBC)—a rare, chronic liver disease. Excessive dosing of Ocaliva in these patients has been associated with increased risk of death or serious liver injury.
According to the FDA, the intent behind the new black box warning is to further clarify and highlight current recommendations for screening, dosing, monitoring, and managing PBC patients who are taking Ocaliva, and whose liver disease is moderate to severe. The FDA now also requires a Medication Guide be included with Ocaliva to better inform patients of potential risks.
Healthcare professionals are advised to refer to Ocaliva’s product label for detailed instructions on selecting appropriate dosage regimens. All patients should be monitored on a routine basis for biochemical response, tolerability, and PBC progression. Because recommended dosing with Ocaliva is based on a patient’s Child-Pugh classification, healthcare providers should also routinely re-evaluate each patient’s Child-Pugh score to determine if their dosage should be adjusted.
The FDA advises that patients be aware of the need for regular tests to monitor liver function during treatment with Ocaliva. They should be informed of the signs and symptoms of declining liver function, and contact their healthcare professional if these become apparent.
In the event a patient experiences an adverse effect or side effect that may be related to the use of Ocaliva, the FDA requests this information be reported to their MedWatch program.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.