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.
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.
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
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