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FDA warns of liver injury, death risks from Intercept's drug
September 21, 2017 / 4:31 PM / 3 months ago

FDA warns of liver injury, death risks from Intercept's drug

Sept 21 (Reuters) - The U.S. Food and Drug Administration (FDA) warned on Thursday that Intercept Pharmaceuticals Inc’s drug Ocaliva was being incorrectly dosed in some patients with a rare liver disease, increasing the risk of liver injury and death.

The U.S. drugmaker’s shares fell 8.7 percent to $89.54 in afternoon trading.

Ocaliva, approved last May, is used to treat primary biliary cholangitis, a rare, chronic liver disease that causes bile ducts in the liver to become inflamed, damaged and destroyed.

The FDA said some patients were receiving higher doses of Ocaliva, particularly due to a higher frequency of dosing than recommended in the drug label. (bit.ly/2hiUvil)

Intercept had sent a letter earlier this month to healthcare providers with prescribing information for the drug, and flagged reports of liver failure and deaths. (bit.ly/2xudehJ) (Reporting by Manas Mishra in Bengaluru; Editing by Sai Sachin Ravikumar)

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