The FDA issued a warning last week that Abbvie’s hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury mostly in patients with underlying advanced liver disease. The FDA is requiring the Abbvie to include information about adverse events of serious liver injury to the Viekira Pak and Technivie drug labels.
Viekira Pak and Technivie are used to treat chronic hepatitis C. Viekira Pak is a combination drug consisting of dasabuvir, ombitasvir, paritaprevir, and ritonavir used with or without ribavirin (another hepatitis C medication). Technivie is very similar; a combination drug of ombitasvir, paritaprevir, and ritonavir, used in combination with ribavirin.
Adverse event reports identified cases of liver injury and failure in patients with underlying liver cirrhosis who were taking these medicines. Some of these events resulted in liver transplantation or death. The most serious outcomes were reported mostly in patients taking Viekira Pak who had evidence of advanced cirrhosis even before starting treatment with the drug.
In most of the reported adverse events liver injury occurred within 1 to 4 weeks of starting treatment. Patients taking these medicines should contact their health care professional immediately if they develop the following symptoms as these may be signs of liver injury:
- loss of appetite,
- nausea and vomiting,
- yellow eyes or skin, or
- light-colored stools.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at 1-800-332-1088. You can read the entire FDA warning here.
At Rheingold, Giuffra, Ruffo & Plotkin LLP, we have over 30 years of experience handling cases of dangerous drugs and medical devices. Call us today to speak with a knowledgeable drug liability attorney: (212) 684-1880.