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FDA Safety Alert: Direct-Acting Antivirals for Hepatitis C

by The GoodRx Pharmacist on November 11, 2016 at 5:03 pm

The FDA has issued a drug safety alert for direct-acting antivirals used to treat Hepatitis C. They warn that using direct-acting antivirals such as Sovaldi, Harvoni, or Zepatier can cause a reactivation of Hepatitis B in patients who have been previously infected with the virus.

The FDA gained knowledge about the reactivation of hepatitis B occurring from direct-acting antivirals through reported incidents and published literature. This is signifiant, because the reactivation of hepatitis B can result in liver problems and even death.

Which medications are considered direct-acting antivirals? 

The following are examples of direct acting antivirals:

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

What is being done to warn people about these side effects?

The FDA is requiring that all direct-acting antivirals have a boxed warning, and the information will be listed in a a drug’s patient information leaflet or medication guide.

A boxed warning, also called a black box warning, is the strongest type of warning the FDA can give to a medication to call attention to serious or life-threatening risks. So, if you see any on your hepatitis medications, be sure to read them!

What are some signs and symptoms that I should be on the lookout for?

If you or someone you know is taking these types of medications, the signs and symptoms that you should seem medical attention for include:

  • Fatigue
  • Weakness
  • Loss of appetite
  • Nausea and vomiting
  • Yellowing of the skin or eyes
  • Light-colored stool

How many cases of reactivated hepatitis B has the FDA received?

At this time, the FDA has only received 24 reported cases, but there are likely additional cases that the FDA is unaware of. Of these 24 reported cases, 2 patients died, and 1 patient had a liver transplant.

What does the FDA recommend to prescribers?

The FDA recommends that prescribers screen all patients for evidence of current or previous hepatitis B infection before starting treatment with direct-acting antivirals. They also recommended that prescribers should test patients for hepatitis B flare-ups, or reactivation during treatment and post-treatment follow-up.


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