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FDA Requires AbbVie to Strengthen Warning Labels

The Food and Drug Administration (FDA) announced that AbbVie’s hepatitis C treatments Viekira Pak and Technivie can cause serious liver damage to patients with underlying advanced liver disease. The FDA will require the new information regarding safety risks be added to the treatments’ warning labels.

If patients undergoing the treatment experience fatigue, weakness, loss of appetite, nausea, vomiting, yellow eyes or skin, or light colored stools, they should immediately contact their doctor or healthcare professional.

At least 26 cases were reported worldwide. In most of the cases, liver injury occurred within the first one to four weeks of treatment. The FDA believes it’s likely there’s more unreported cases.

Some of the cases resulted in patients undergoing liver transplants or death. The most serious cases occurred in patients taking Viekira Pak who had evidence of advanced cirrhosis before beginning treatment.

Technivie was approved in July 2015 for patients with chronic hepatitis C genotype 4. Genotype 4 is one of the rarer genotypes, and Technivie was one of the first treatments which demonstrated success with the genotype without the use of interferon.

Viekira Pak received approval in December 2014 for patients with chronic hepatitis C genotype 1. Genotype 1 is the most common genotype found in the United States and Europe.1

The FDA is requesting healthcare professionals and patients to report any side effects involving Viekira Pak and Technivie here.

As always, do not stop, start, or change any treatment without first discussing with your healthcare provider.

For more information regarding updates to AbbVie’s labels, visit the FDA’s announcement.

  1. FDA Drug Safety Communication: FDA warns of serious liver injury risk with hepatitis C treatments Viekira Pak and Technivie. The Food and Drug Administration. Published October 22, 2015. Accessed October 22, 2015.