Patients who are prescribed an excessive dosage of chronic liver disease medication Ocaliva® may face an increased risk of serious liver injury and possibly death, the Food and Drug Administration warned.
Manufactured by Intercept Pharmaceutical, Ocaliva was approved by the FDA in May 2016 and is used to treat primary biliary cholangitis (PBC), a rare form of liver disease that causes the bile ducts to become inflamed, leading to bile build-up and liver damage.
In just over a year since Ocaliva was approved, the FDA announced that it received reports of 19 deaths and 11 cases of serious liver injuries in patients who had taken Ocaliva. Of the 11 cases of serious liver injury, three later died.
In many of the cases, the patients had moderate to severe decreased liver function and were prescribed 5mg of Ocaliva on a daily basis. The drug’s label, however, recommends a dose no greater than 10 mg twice weekly for that extent of liver damage, the FDA stated.
The FDA recommends that health care professionals carefully determine a patient’s baseline liver function before starting Ocaliva in order to ensure that the correct dosage is prescribed. Doctors should also closely monitor for disease progression and reduce dosage if needed.
Signs of liver injury and disease progression include: