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Federal Regulators Warn Against Use of AbbVie's Hepatitis C Drugs

Jan 6, 2016

The U.S. Food and Drug Administration (FDA) recently issued a "Safety Communication" concerning AbbVie's Viekira Pak and Technivie; both are hepatitis C treatments.

According to the FDA, Viekira Pak and Technivie are prescribed for the treatment of chronic hepatitis C. Hepatitis C is a viral infection that may last throughout a patient's lifetime and may lead to serious liver and other health problems, such as cirrhosis, liver cancer, and death.

Viekira Pak and Technivie are prescribed to minimize the level of hepatitis C virus in the patient's body, which may prevent the disease from multiplying and may also slow down the disease's progression. The medications have also been associated with serious liver injury, typically in patients who have been diagnosed with advanced liver disease. Because of this, the FDA is requiring that AbbVie add the new information about this safety risk to the drugs' labels; specifically, 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. Signs of liver injury include:

  • Fatigue
  • Light-colored stools
  • Loss of appetite
  • Nausea
  • Vomiting
  • Weakness
  • Yellow Eyes
  • Yellow Skin

The FDA advised that patients experiencing any of these symptoms while on AbbVie's Viekira Pak and Technivie should contact their health care provider and not stop treatment early without physician approval. Stopping treatment early may lead to drug resistance to other hepatitis C drugs. The FDA also advises health care professionals to closely monitor patients for signs and symptoms of worsening liver disease, which include: ascites, hepatic encephalopathy, variceal hemorrhage, and/or increases in the blood's direct bilirubin levels.

The FDA's review of adverse events reported to its own Adverse Event Reporting System (FAERS) database, as well as 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 events resulted in the need for liver transplantation; some cases led to death. These serious case were generally reported in patients taking Viekira Pak and who had evidence of advanced cirrhosis prior to treatment. Of note, FAERS includes only those reports to the FDA, which means there are likely more cases of which the FDA is unaware.

Viekira Pak was approved in December 2014 and Technivie in July 2015; since, at least 26 cases have been reported worldwide to FAERS that were considered to be possibly or probably related to Viekira Pak or Technivie. In most cases, liver injury took place within one to four weeks of beginning treatment. Some cases occurred in patients for whom these medicines were contraindicated or not recommended.

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