AUA asks FDA to alter language on recent 5-ARI alert

August 4, 2011

The AUA is asking the FDA to remove or alter certain language in a recent FDA alert concerning 5-alpha-reductase inhibitor therapy.

The AUA is asking the FDA to remove or alter certain language in a recent FDA alert concerning 5-alpha-reductase inhibitor therapy.

In a letter signed by AUA President Sushil S. Lacy, MD, the AUA pointed out the wording of the following item in the FDA alert: "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)."

The AUA asked that the FDA remove or alter the phrasing "appropriate evaluation" when considering considering men with BPH as candidates for 5-ARI therapy.

"Because a biopsy is the most effective means by which we can distinguish malignant from benign disease, the current wording implies that all men obtain a routine prostate biopsy prior to commencing treatment-something that is, at present, not supported by the literature. In fact, it is our understanding of the literature that the 'appropriate evaluation' of patients prior to 5-ARI therapy is unclear.

"In our opinion, the language, as written, is far too broad-and puts physicians at risk of inconsistent interpretation and associated legal issues."

The letter pointed out several issues related to prostate cancer detection, including limitations of the PSA test, a lack of noninvasive alternatives to needle biopsy, and potential safety concerns, including risk of sepsis, related to overuse of biopsy.