Phosphodiesterase Type 5 (PDE5) Inhibitors & Exposure in Pregnancy

    Basic Details
    Status
    Complete
    Last Updated
    Monday, March 18, 2019
    Health Outcome(s)
    exposure in pregnancy
    Purpose
    Drug Use
    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.