AUA comments on FDA guidance on safe use of 5-ARIs


The American Urological Association (AUA) has written to the U.S. Food & Drug Administration (FDA) seeking modification of the FDA’s recent guidance on the use of 5α-reductase inhibitors like dutasteride and finasteride in the management of urologic conditions.

Specifically, the AUA is requesting removal of the following statement from the FDA’s guidance document:

Prior to initiating therapy with 5-ARIs, perform appropriate evaluation to rule out other urological conditions, including prostate cancer, that might mimic benign prostatic hyperplasia (BPH).

For the explanation of this request and the full text of the AUA’s letter to the Commissioner of the FDA, please click here. The AUA believes that this language is unclear and potentially problematic in the clinical setting. The “New” Prostate Cancer InfoLink agrees with the AUA’s request.

One Response

  1. I’m convinced the FDA’s position that effectively opposes use of 5-alpha reductase inhibitors is fundamentally unsound, and I’m delighted the AUA is challenging the FDA. I am now doing a thorough review of the transcript of the FDA ODAC committee hearing on a finasteride label change suggesting potential for prevention (from December 1, 2010) and associated materials. It is not hard to spot some major flaws in the FDA position. I’m hopeful that the survivor community will take this on as a cause.

    At this point, I believe, as do many, that the use of 5-ARI drugs makes detection of high Gleason disease more likely, and I suspect that the 5-ARI trialists are correct in their analyses indicating that finasteride actually decreases the true incidence of high Gleason score disease.

    Of course the FDA is not opposing the use of 5-ARIs for BPH. Their opposition relates to 5-ARIs in the context of prostate cancer or possible prostate cancer, including prevention.

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