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Phosphodiesterase Type 5 (PDE5) Inhibitors & Exposure in Pregnancy

Basic Details
Status
Complete
Last Updated
Monday, October 5, 2020
Original Posting Date
Health Outcome(s)
exposure in pregnancy
Purpose
Drug Use
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
Regulatory Determination / Use

Use of PDE5 inhibitors was assessed among reproductive age women, including among pregnant women, to investigate a concern arising from an international clinical trial.  FDA decided that no action is necessary at this time, based on available information.

Result(s) (1)
Phosphodiesterase Type 5 (PDE-5) Inhibitor Utilization Among Women
Related Publication(s) and/or Presentation(s) (2)
Presentation: Phosphodiesterase Type 5 (PDE-5) Inhibitor Use Among Pregnant Women and Women of Reproductive Age in the United States Publication: Phosphodiesterase Type 5 Inhibitor Use Among Pregnant and Reproductive‐Age Women in the United States