The U.S. Food and Drug Administration warned that Intercept Pharmaceuticals' drug Ocaliva was being incorrectly dosed in some patients with a rare liver disease, increasing the risk of liver injury and death, according to a Reuters article.
Intercept reportedly gave healthcare providers prescribing information for Ocaliva and flagged the reports of liver failure and deaths, the story said. Even though the cause of death wasn’t available in most cases, seven of the patients who died were taking Ocaliva more frequently than is recommended, the FDA said.
Ocaliva treats primary biliary cholangitis (PBC), a rare, chronic liver disease that causes bile ducts in the liver to become inflamed, damaged and destroyed.
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