Viekira Pak and Technivie Label Updated to Include Risk of Liver Injury

The warning labels of AbbVie’s hepatitis C treatments Viekira Pak and Techivie have been updated to include the risk of serious liver injury, the U.S. Food and Drug Administration (FDA) said in a safety notification. The agency stated that the treatments were linked to cases of hepatic decompensation and liver failure in a review of the agency’s Adverse Event Reporting System (FAERS) database and in cases reported to AbbVie, mostly in patients who already had underlying liver cirrhosis. “These serious outcomes were reported mostly in patients taking Viekira Pak who had evidence of advanced cirrhosis even before starting treatment with it.” the FDA said.

There have been 26 worldwide cases of liver injury that are possible or probably linked to the treatments since the approval of Viekira Pak in December 2014 and Technivie in July 2015. The FDA says liver injury occurred between 1 and 4 weeks of starting treatment in most cases.

According to the Centers for Disease Control and Prevention (CDC), hepatitis C becomes a long-term, chronic infection occurs in 70 to 85 percent of people infected. Hepatitis C is caused by a bloodborne virus that leads to liver infection. Viekira Pak and Technivie are used to treat patients who have chronic hepatitis C.

Patients taking Viekira Pak or Technivie should contact their health care professional if they experience “fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools, as these may be signs of liver injury” the FDA states. Patients should not stop taking their medications without first discussing it with their health care professional, the agency says.

from Parker Waichman http://www.yourlawyer.com/blog/17392-2/