Side Effects of Viekira Pak and Technivie Carry Serious Liver Injury Risk: FDA

Federal health regulators are warning that side effects of the hepatitis C drugs Viekira Pak and Technivie may cause serious liver injury and even death. 

The FDA issued a drug safety communication on October 22, announcing that new label warnings will be added to the two AbbVie drugs.

According to the agency’s determinations, the side effects of Viekira Pak and Technivie can cause serious liver injury, particularly in those patients who have underlying advanced liver disease.

The two drugs are used to treat chronic hepatitis C, and Viekira Pak has only been on the market since December 2014. Technivie was just approved in July 2015. However, the FDA indicates that at least 25 worldwide cases of liver damage were attributed to the drugs by July.

The injuries appear to occur within one to four weeks of starting treatment. In some cases, the patients were contraindicated and doctors prescribed the drugs despite existing warnings that use by patients with those conditions was not recommended.

“Our review of adverse events reported to the FDA Adverse Event Reporting System (FAERS) database and to the manufacturer of these medicines, AbbVie, identified cases of hepatic decompensation and liver failure in patients with underlying liver cirrhosis who were taking these medicines. Some of these events resulted in liver transplantation or death,” the FDA warning notes. “These serious outcomes were reported mostly in patients taking Viekira Pak who had evidence of advanced cirrhosis even before starting treatment with it.”

Viekira Pak and Technivie are combination drugs that involve several active ingredients. Viekira Pak consists of dasabuvir, ombitasvir, paritaprevir, and ritonavir, while Technivie is a combination of ombitasvir, paritaprevir, and ritonavir. Both are often used in combination with ribavarin. Viekira Pak is approved for use in patients with genotype 1 chronic hepatitis C infections, including those with compensated cirrhosis. Technivie is approved for treatment of patients with genotype 4 chronic hepatitis C virus infection without cirrhosis.

An estimated 10,104 patients in the U.S. filled prescriptions for Viekira Pak between December 2014 and August 2015. No prescription data is yet available for Technivie.

AbbVie acknowledged that it would add label warnings in an October 22 press release. The company also said it would issue a “Dear Health Care Provider” letter to inform medical professionals about the changes.

The FDA is warning patients who are taking the drugs that they may cause serious, including life-threatening, liver injuries. Those taking the drugs should contact their doctor right away if they experience:

• Fatigue
• Weakness
• Loss of appetite
• Nausea and vomiting
• Yellow eyes or skin
• Light-colored stools