FDA has recommended that prior to initiating therapy with 5-alpha reductase inhibitors (ARIs) like finasteride or Dutasteride, the healthcare professionals should perform appropriate evaluation to rule out other urological conditions, including prostate cancer, that might mimic benign prostatic hyperplasia (BPH).
The Warnings and Precautions section of the labels for the 5-ARI class of drugs has been revised to include new safety information about the increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer).
The decision has been taken in view of the results of two large randomised controlled trials (RCTs) conducted in 2010-the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial.
Finasteride and Dutasteride are available as Proscar, Avodart, and Jalyn.
These are approved to improve symptoms of benign prostatic hyperplasia (BPH).
Proscar and Avodart are also approved to reduce the risk of urinary retention or surgery related to an enlarged prostate.
Propecia is approved to treat male pattern hair loss.
Ironically, 5-ARIs were used for chemoprevention of prostate cancer without the FDA approval.
Also, the guidelines released jointly in 2009 by the American Society of Clinical Oncologists and the American Urological Association recommended that, "Asymptomatic men with a prostate-specific antigen (PSA) ≤3.0 ng/mL who are regularly screened with PSA or are anticipating undergoing annual PSA screening for early detection of prostate cancer may benefit from a discussion of both the benefits of 5-ARIs for 7 years for the prevention of prostate cancer and the potential risks (including the possibility of high-grade prostate cancer)." (1)
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm258529.htm
(1) http://caonline.amcancersoc.org/cgi/content/full/61/1/1
The Warnings and Precautions section of the labels for the 5-ARI class of drugs has been revised to include new safety information about the increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer).
The decision has been taken in view of the results of two large randomised controlled trials (RCTs) conducted in 2010-the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial.
Finasteride and Dutasteride are available as Proscar, Avodart, and Jalyn.
These are approved to improve symptoms of benign prostatic hyperplasia (BPH).
Proscar and Avodart are also approved to reduce the risk of urinary retention or surgery related to an enlarged prostate.
Propecia is approved to treat male pattern hair loss.
Ironically, 5-ARIs were used for chemoprevention of prostate cancer without the FDA approval.
Also, the guidelines released jointly in 2009 by the American Society of Clinical Oncologists and the American Urological Association recommended that, "Asymptomatic men with a prostate-specific antigen (PSA) ≤3.0 ng/mL who are regularly screened with PSA or are anticipating undergoing annual PSA screening for early detection of prostate cancer may benefit from a discussion of both the benefits of 5-ARIs for 7 years for the prevention of prostate cancer and the potential risks (including the possibility of high-grade prostate cancer)." (1)
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm258529.htm
(1) http://caonline.amcancersoc.org/cgi/content/full/61/1/1
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