FDA Orders Warnings About Severe Liver Injury On 2 New Hepatitis C Drugs

(October 28, 2015, 12:30 PM EDT) -- SILVER SPRING, Md. — The Food and Drug Administration on Oct. 23 said it has ordered new warnings added to the labels of the hepatitis C treatments Viekira Pak and Technivie after reports of serious liver injury in patients taking the recently approved drugs.

Viekira Pak is a fixed-dose combination of dasabuvir, ombitasivir, paritaprevir and ritonavir; it was approved in December 2014 to treat patients with the hepatitis C virus, with or without concurrent use of ribavirin, another hepatitis C drug. Technivie, approved in July, is...
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