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Lupron Depot PED (Leuprolide Acetate) & Major Fracture, Any Fracture, Hip Replacement, and Temporomandibular Joint Replacement

    Basic Details
    Last Updated
    Friday, September 16, 2022
    Original Posting Date
    Health Outcome(s)
    any fracture
    hip replacement
    major fracture (primary)
    temporomandibular joint replacement
    Drug and Outcome Analysis
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    In response to case reports describing musculoskeletal adverse events, including decreases in bone density, in young adults who had been exposed to leuprolide acetate during childhood, the FDA further evaluated the risk of fracture with the use of gonadotropin-releasing hormone (GnRH) agonists indicated for the treatment of central precocious puberty (CPP), including leuprolide acetate. The Sentinel analysis estimated the risk of major fractures among individuals with CPP who initiated leuprolide acetate during childhood and compared them with leuprolide acetate-unexposed age- and sex-matched reference populations with and without CPP. Compared separately to the leuprolide-unexposed children with or without CPP, the study observed a lower risk of fracture in female leuprolide users with CPP, but no statistically significant difference in fracture risk for male leuprolide users with CPP. Results from the post hoc analysis were consistent with the findings from the main analysis. Because results from this study provided no evidence for an increased risk of fracture following leuprolide use during childhood, FDA determined that no regulatory action is needed at this time.