The Food and Drug Administration (FDA) is warning consumers that patients with underlying advanced liver disease risk serious liver injury by using two hepatitis C treatments -- Viekira Pak and Technivie -- manufactured by AbbVie.
Both of the AbbVie drugs are used to treat chronic hepatitis C, a condition caused by a viral infection that can cause liver cirrhosis, cancer and even death. The AbbVie medications work to slow the multiplication of hepatitis C virus in the body.
The FDA said that adverse event reports submitted to the agency and to the manufacturer showed that some patients with underlying advanced liver disease suffered liver failure and hepatic decompensation as a result of taking these medications. Some of the incidences reported resulted in liver transplantation or death.
Viekira Pak was approved in December 2014 and Technivie received approval in July 2015. Since those approvals, the FDA has received at least 26 worldwide reports of liver injury due to the medications, which typically occurred 1-4 weeks after beginning treatment. Of the 26 cases reported, 10 patients either required a liver transplant or died; 16 patients experienced liver dysfunction.
The FDA has ordered AbbVie to include information about these serious liver injury risks on drug labels for Viekira Pak and Technivie. AbbVie said that package inserts for the drugs have been changed to note they should not be prescribed for patients with advanced liver disease caused by hepatitis. AbbVie is also recommending that physicians screen patients for evidence of liver decompensation before and during treatment.
Before taking Viekira Pak or Technivie, patients should tell their doctors if they have liver problems other than hepatitis C, have been diagnosed with HIV or are taking birth control medication that contains ethinyl estradiol.
"Patients taking these medicines should contact their health care professional immediately if they develop 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 said.
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