Adverse Event Reporting in Clinical Trials of Finasteride for Androgenic Alopecia: A Meta-analysis.

    June 2015 in “ PubMed
    Steven M. Belknap, Imran Aslam, Tina Kiguradze, William H. Temps, Paul R. Yarnold, John Cashy, Robert E. Brannigan, Giuseppe Micali, Beatrice Nardone, Dennis P. West
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    TLDR Finasteride for hair loss may cause long-lasting side effects like impotence and low libido, but trials lack proper safety reporting.
    This meta-analysis evaluated the safety reporting of clinical trials of finasteride for androgenic alopecia (AGA) and found that none of the 34 clinical trials analyzed had adequate safety reporting. The quality of adverse event reporting in clinical trials of finasteride for AGA was inadequate, and recent reports describe that impotence, loss of libido, low androgen levels, and severe oligospermia may persist long after discontinuation of finasteride at a dosage of 1.25 mg/d or less. The study concludes that validated, effective methods for detecting adverse events, grading their severity, and evaluating causality should be used in clinical trials to identify and characterize drug toxicity.
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