New Black Box Warnings Spur Lawsuits

Lawsuits may be emerging soon after the FDA issued a Black Box Warning for 9 direct-acting antiviral (DAA) medications this October 2016. Patients who have taken DAA medications and seen a reemergence of their Hepatitis B, experienced liver damage, or suffered liver failure, may be eligible to file a lawsuit against the drug manufacturers. According to the FDA, this reactivation usually occurred within 4-8 weeks of receiving DAA treatment drugs. During clinical trials, this potentially deadly side effect was not discovered because researchers only recruited patient with Hepatitis C and no co-infections.

What Medications Have Been Affected by FDA Black Box Warning

To date, the following DAA medications were part of the FDA Black Box Warning:

  • Daklinza
  • Epclusa
  • Harvoni
  • Olysio
  • Sovaldi
  • Technivie
  • Viekira Pak
  • Viekira Pak XR
  • Zepatier

Patients who have Hepatitis C and are considering DAA drug treatment should notify their doctor if they have also been previously diagnosed with HBV. Doctors should also screen patients for HBV prior to starting Hepatitis C drug treatment and they should monitor HBV patients closely for signs of liver failure, liver damage, or adverse reactions.

Signs of Hepatitis B (HBV) Reemergence

Patients who have signs of liver damage or liver failure should notify their physician immediately. Some of those signs include:

  • Jaundice
  • Yellow eyes and skin
  • Nausea
  • Vomiting
  • Fatigue or weakness
  • Loss of Appetite
  • Light colored stools


Posted to: Supplemental Research


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