Worst Pills, Best Pills

An expert, independent second opinion on more than 1,800 prescription drugs, over-the-counter medications, and supplements

Black-Box Warning Added to Hepatitis C Drugs

Worst Pills, Best Pills Newsletter article September, 2017

On Oct. 4, 2016, the Food and Drug Administration (FDA) released a warning that medications known as direct-acting antivirals (DAAs), which are used to treat hepatitis C, can reactivate the hepatitis B virus in patients with current or previous hepatitis B infections.[1] Examples of DAAs include sofosbuvir (SOVALDI), the fixed-dose combination of ledipasvir and sofosbuvir (HARVONI), and simeprevir (OLYSIO).

The FDA based its alert on cases, reported to the agency, of confirmed...

On Oct. 4, 2016, the Food and Drug Administration (FDA) released a warning that medications known as direct-acting antivirals (DAAs), which are used to treat hepatitis C, can reactivate the hepatitis B virus in patients with current or previous hepatitis B infections.[1] Examples of DAAs include sofosbuvir (SOVALDI), the fixed-dose combination of ledipasvir and sofosbuvir (HARVONI), and simeprevir (OLYSIO).

The FDA based its alert on cases, reported to the agency, of confirmed reactivation of hepatitis B virus in patients who were receiving treatment with DAAs for hepatitis C infection. Hepatitis B reactivation usually occurred four to eight weeks after the start of DAA treatment. Two patients died, and one required a liver transplant.

The agency has updated the product labels for all DAAs to carry a blackbox warning — the most serious warning the FDA can require — that explains this risk of hepatitis B reactivation.

Before starting a DAA, tell your doctor whether you have ever had hepatitis B or other liver problems. If you have had hepatitis B and start a DAA, your doctor should monitor you with blood tests to see whether the hepatitis B infection reactivates while you are taking a DAA, and for several months after you stop the medication.

After you start a DAA, tell your doctor immediately if you experience fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools, as these might be signs of a serious liver problem related to hepatitis B reactivation. To see the FDA’s safety alert, visit the following webpage: http://www.fda.gov/ Drugs/DrugSafety/ucm522932.htm.

References

[1] FDA Drug Safety Communication: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C. October 4, 2016. http://www.fda.gov/Drugs/DrugSafety/ucm522932.htm. Accessed May 18, 2017.