FDA News

FDA revises Viread pregnancy data: ‘no increased risk for adverse outcomes’

The FDA approved revisions to the Viread product labeling to include safety and pregnancy-related outcome data from three published trials in pregnant women with chronic hepatitis B.

The update reads as follows: “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.”

The controlled trials comprised 327 women who received Viread (tenofovir disoproxil fumarate or TDF, Gilead) between 28 weeks to 32 weeks gestation through 1 month to 2 months postpartum and followed for up to 12 months after delivery.

Results showed no new safety findings and no increased risk for adverse pregnancy-related outcomes in pregnant women compared with the known safety profile of TDF.

Researchers reported two stillbirths, one case of talipes, and one occurrence of multiple congenital abnormalities in infants exposed to TDF. At 12 months follow-up of the full cohort of infants, the researchers found no clinically relevant drug-related safety findings.

 

Reference: www.fda.gov

The FDA approved revisions to the Viread product labeling to include safety and pregnancy-related outcome data from three published trials in pregnant women with chronic hepatitis B.

The update reads as follows: “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.”

The controlled trials comprised 327 women who received Viread (tenofovir disoproxil fumarate or TDF, Gilead) between 28 weeks to 32 weeks gestation through 1 month to 2 months postpartum and followed for up to 12 months after delivery.

Results showed no new safety findings and no increased risk for adverse pregnancy-related outcomes in pregnant women compared with the known safety profile of TDF.

Researchers reported two stillbirths, one case of talipes, and one occurrence of multiple congenital abnormalities in infants exposed to TDF. At 12 months follow-up of the full cohort of infants, the researchers found no clinically relevant drug-related safety findings.

 

Reference: www.fda.gov