FDA Issues Drug Safety Warning for Hepatitis C Drugs

For patients with underlying advanced liver disease, the hepatitis C infection treatments Viekira Pak (AbbVie) and Technivie (AbbVie) may increase the risk for serious liver injury, according to a drug safety communication from the Food and Drug Administration (FDA).

The statement reads, in part: “FDA is warning that hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury mostly in patients with underlying advanced liver disease. As a result, FDA is requiring the manufacturer to include information about serious liver injury adverse events to the Contraindications, Warnings and Precautions, Postmarketing Experience, and Hepatic Impairment sections of the Viekira Pak and Technivie drug labels.”

The statement further notes that the serious outcomes were reported mostly in patients taking Viekira Pak who had evidence of advanced cirrhosis even before starting treatment with it. In most cases, the FDA noted, liver injury occurred within 1 to 4 weeks of starting treatment. Some of the cases occurred in patients for whom these medicines were contraindicated or not recommended.

In a statement, AbbVie noted that, “Most patients with these severe outcomes had evidence of advanced cirrhosis prior to initiating therapy. Because post-marketing events are reported voluntarily during clinical practice, estimates of frequency cannot be made and a causal relationship between treatment and these events has not been established.”

Viekira Pak and Technivie are part of a number of recent medications developed to treat Hepatitis C. Viekira Pak is a fixed-dose combination of dasabuvir, ombitasvir, paritaprevir, and ritonavir used with or without ribavirin, another hepatitis C medicine. Technivie is a fixed-dose combination of ombitasvir, paritaprevir, and ritonavir, used in combination with ribavirin.

The FDA will now require the company to add information about serious liver injury adverse events to the Contraindications, Warnings and Precautions, Postmarketing Experience, and Hepatic Impairment sections of the Viekira Pak and Technivie drug labels.

The adverse events were noted in the FDA’s initial review of the medications. “Most patients with these severe outcomes had evidence of advanced cirrhosis prior to initiating therapy,” AbbVie noted in a response to the FDA action. “Because post-marketing events are reported voluntarily during clinical practice, estimates of frequency cannot be made and a causal relationship between treatment and these events has not been established.”

Physicians should inform patients taking these medicines to 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. Patients should not stop taking these medicines without first talking to their health care professionals. Stopping treatment early could result in drug resistance to other hepatitis C medicines.