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Heightened Risk for High-grade Prostate Cancer Prompts FDA Action on 5-Alpha Reductase Inhibitors
Despite Overall Low Cancer Risk, Agency Calls for Label Changes
By News Staff
About 5 million male patients received a prescription for a 5-ARI from 2002 to 2009, according to the FDA.
The labeling change affects the following drugs:
- finasteride, which is marketed as Propecia in 1-milligram strength and Proscar in 5-milligram strength;
- dutasteride, which as marketed as Avodart; and
- dutasteride in combination with tamsulosin, which is marketed as Jalyn.
The FDA made the labeling change based on its review of two large randomized, double-blind, controlled trials -- the Prostate Cancer Prevention Trial, or PCPT, and the Reduction by Dutasteride of Prostate Cancer Events, or REDUCE, trial. The two trials demonstrated an overall reduction in prostate cancer diagnoses with 5-milligram finasteride (a 26 percent reduction among treated men in the PCPT) and 0.5-milligram dutasteride (a 23 percent reduction among treated men in the REDUCE trial), respectively. Specifically, this reduction was due to a decreased incidence of lower risk forms of prostate cancer (Gleason Score, or GS, 6 or lower). However, both trials showed an increased incidence of high-grade prostate cancer (GS 8 or greater) among treated men versus those taking placebo (PCPT: 1.8 percent versus 1.1 percent; REDUCE trial: 1.0 percent versus 0.5 percent).
The agency issued the following information for health care professionals:
- Before initiating therapy with 5-ARIs, perform appropriate evaluation to rule out other urological conditions -- including prostate cancer -- that might mimic BPH.
- Be aware that treatment with 5-ARIs causes an approximate 50 percent reduction in prostate-specific antigen, or PSA, values within six months; however, individual patients receiving 5-ARIs may experience varying decreases in PSA values. Therefore, any confirmed increase in PSA while on a 5-ARI may signal the presence of prostate cancer and should be evaluated, even if that PSA is in the normal range of men not taking a 5-ARI.
- Know that 5-ARIs are not approved for the prevention of prostate cancer.
- Report any adverse events involving 5-ARIs to the FDA's MedWatch program.
Clinical Preventive Services: Prostate Cancer
FDA Drug Safety Communication: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer
(June 9, 2011)
FDA: Questions and Answers: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer
(June 9, 2011)