FDA Drug Safety Communication on risk of serious liver injury with hepatitis C treatments Viekira Pak and Technivie -

FDA Drug Safety Communication on risk of serious liver injury with hepatitis C treatments Viekira Pak and Technivie
Information type: Safety alerts
Source: US Food and Drug Administration
Specialities: Liver disorders
Summary
As these treatments can cause serious liver injury, mostly in patients with underlying advanced liver disease, the FDA is requiring the manufacturer to include information about serious liver injury adverse effects in the drug labels.
UKMi comment
Viekira Pak is a fixed-dose combination of dasabuvir, ombitasvir, paritaprevir, and ritonavir used with or without ribavirin. Technivie is a fixed-dose combination of ombitasvir, paritaprevir, and ritonavir, used in combination with ribavirin. In the UK, this combination is available under the brand name Viekirax. The safety alert applies only to the US products.
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