Hepatitis Update

FDA Hepatitis Updates provide information about FDA Hepatitis product approval, safety warnings, medical product labeling changes, notices of upcoming meetings, and notices about proposed regulatory guidances.

April 25, 2019

FDA recently approved revisions to the VIREAD (tenofovir disoproxil fumarate) product labeling to include safety and pregnancy-related outcome information from three published controlled trials in pregnant women with chronic hepatitis B virus infection who were administered VIREAD during their third trimester.

Section 8.1 Pregnancy was updated as follows:

Risk Summary

Published studies in HBV-infected subjects do not report an increased risk of adverse pregnancy-related outcomes with the use of VIREAD during the third trimester of pregnancy.

Human Data

In published data from three controlled clinical trials, a total of 327 pregnant women with chronic HBV infection were administered VIREAD from 28 to 32 weeks gestation through 1 to 2 months postpartum and followed for up to 12 months after delivery. There were no new safety findings in pregnant women compared with the known safety profile of VIREAD in HBV-infected adults. An increased risk of adverse pregnancy-related outcomes was not observed; 2 stillbirths were identified, and there was 1 major birth defect (talipes) and 1 occurrence of multiple congenital abnormalities (not further specified) in VIREAD-exposed infants. Infants were followed for up to 12 months after delivery; there were no clinically relevant drug-related safety findings in infants exposed to VIREAD during late gestation.

The updated label will soon be available at drugs@fda or DailyMed Kimberly Struble Division of Antiviral Products Food and Drug Administration Elizabeth Thompson Division of Antiviral Products Food and Drug Administration Michael Stanfield Jr. Division of Antiviral Products Food and Drug Administration Our free e-mail alert service allows you to receive important FDA news and information as they become available. Sign up for FDA email updates https://updates.fda.gov/subscriptionmanagement and then select the topics that are of interest to you.