Assessing Dutasteride-Associated Sexual Dysfunction Using the U.S. Food and Drug Administration Adverse Event Reporting System

    December 2017 in “ Journal of the European Academy of Dermatology and Venereology ”
    Aditya K. Gupta, Jessie Carviel, Madhulika A. Gupta, Neil H. Shear
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    TLDR Dutasteride is linked to a higher chance of sexual dysfunction, especially in younger males and the elderly.
    The study analyzed the FAERS database to evaluate the risk of sexual dysfunction in dutasteride users, a drug for benign prostatic hyperplasia and androgenetic alopecia. It found a significant increase in reports of sexual dysfunction across all age groups, except for those aged 31-45 years. The highest risk was observed in the 76-92 years age group. The unadjusted Reporting Odds Ratios (ROR) indicated a particularly high risk in younger males, with an ROR of 21.93 for ages 31-45 and 76.68 for ages 17-30. The adjusted, weighted average ROR was 5.51 (p-value <0.001), confirming a statistically significant association between dutasteride and sexual dysfunction. The study suggests further research is needed to identify at-risk populations and calls for caution in the use of dutasteride. Limitations included potential underreporting and selection bias in the FAERS database.
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