Breaking Breaking
STAT News

STAT+: In first speech to her FDA staff, Høeg says she’ll scrutinize RSV shots and SSRIs in pregnancy

myndfocal
The top drug regulator at the FDA told staff she plans to question the safety of taking SSRIs in pregnancy and of RSV shots given to infants.

WASHINGTON — Tracy Beth Høeg, the top drug regulator at the Food and Drug Administration, indicated in her first address to staff that she’ll scrutinize antidepressants and the shots used to protect babies from RSV.

Høeg told employees on Thursday that her top priorities include two issues she’s focused on in the recent past: evaluating the safety of antidepressants taken by pregnant women and of monoclonal antibodies that protect infants against RSV.

“I’ve been interested to learn we really haven’t been doing sort of thorough safety monitoring of these products during pregnancy, and so I think we could do a better job,” Høeg said. “I actually think that there’s agreement about that, and among the CDER staff that I’ve been working with on this issue, so I’m excited to see that.”

Continue to STAT+ to read the full story…

— Source: STAT News (https://www.statnews.com/2026/02/19/tracy-beth-hoeg-fda-speech-to-staff-ssris-in-pregnancy-rsv-shots/)

Health & Biotech
Read original on STAT News →