While the cause of death wasn’t available in all cases, seven of the patients who died were taking an increased dosage, above what was recommended. The FDA also identified 11 cases of serious liver injury from Ocaliva use, warning that this injury may occur even in patients receiving the correct dose.
“Ocaliva is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death … it may also be associated with liver injury in some patients with mild disease who are receiving the correct dose,” the FDA said.
The FDA is suggesting that physicians determine a patient’s baseline liver function and warn patients of increased risks prior to prescribing Ocaliva. In addition, the FDA is recommending all physicians screen patients for worsening liver injury while taking the drug.
The FDA approved Ocaliva in May 2016 to treat primary biliary cholangitis, a chronic liver disease that causes bile ducts to become inflamed, damaged and destroyed.
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