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Phosphodiesterase Type 5 (PDE5) Inhibitors & Exposure in Pregnancy

    Basic Details
    Last Updated
    Monday, October 5, 2020
    Original Posting Date
    Health Outcome(s)
    exposure in pregnancy
    Drug Use
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    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.