Finasteride And Dutasteride Raise Risk Of High-Grade Prostate Cancer, FDA Informs
Editor's ChoiceMain Category: Prostate / Prostate Cancer
Also Included In: Urology / Nephrology; Regulatory Affairs / Drug Approvals
Article Date: 10 Jun 2011 - 7:00 PDT
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opinionsFinasteride And Dutasteride Raise Risk Of High-Grade Prostate Cancer, FDA Informs
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Although finasteride and dutasteride lower overall risk of developing prostate cancer, they raise the chances of developing high-grade prostate cancer, a more serious form of the disease, the FDA (Food and Drug Administration) has announced. The Agency adds that the risk is low; but doctors need to be aware of this.
The FDA announced that all 5-alpha reductase inhibitor (5-ARI) medications will now have new safety information about the risk of developing high-grade prostate in their labeling, in the Warnings and Precautions section.
Examples of 5-ARI class medications include finasteride (Proscar, Propecia), dutasteride (Avodart), turosteride, bexlosteride and izonsteride. They are drugs with antiandrogenic activity and are used to treat benign prostatic hyperplasia (prostate gland enlargement) and androgenic alopecia (hair loss, baldness).
The FDA evaluated two randomized controlled trials - PCPT (the Prostate Cancer Prevention Trial), which compared finasteride 5mg against placebo for 7 years, and REDUCE (Reduction by Dutasteride of Prostate Cancer Events trial), which compared dutasteride 0.5 mg against placebo for 4 years. Both trials were measuring prostate cancer risk reduction in males aged 50+ years.
Even though both studies demonstrated an overall reduction in prostate cancer risk with both drugs, they also showed a higher risk of high-grade prostate cancer.
High-grade prostate cancer (Gleason score between 8 and 10) is the most deadly form of prostate cancer. It is an aggressive cancer which grows and spreads into surrounding areas rapidly. The cancer cells are large, very difficult to treat, and frequently reappear.
The FDA stresses that patients should talk to their doctors first before deciding on whether to change or stop any prescription medication.
Finasteride is marketed by Merck. Dutasteride is marketed by GlaxoSmithKline.
Written by Christian Nordqvist
Copyright: Medical News Today
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Visitor Opinions (latest shown first)
Confusing conclusions
posted by Richard Gillespie on 18 Aug 2011 at 3:27 pmI am currently taking avodart (min dosage 0.5 mg) plus a variety of vitamins and supplments which have been shown to slow prostate cancer growth.Adding 2 50 mg does of casodex weekly, has resulted in my PSA now 0.14.My medical oncologist states that keeping my PSA very low with these agents will keep my cancer very low grade, or slow growing..
What these latest FDA warnings conclude is that while keeping my low grade cancer low, Minimum dose Avodart actually is increasing the chances that I will develop high grade cancer. How could this happen? I am really confused. chapter
Finasteride may also cause Male Breast Cancer & Erectile Dysfunction
posted by Robert Kramer on 27 Jun 2011 at 8:48 amDrugs that contain finasteride whose side effect include high-grade prostate cancer but now may also cause male breast cancer and erectile dysfunction, among some other side effects.
High grade prostate cancer
posted by JB on 12 Jun 2011 at 2:57 amIn recent years, articles concerning 5-alpha reductase inhibitors have been reassuring that these did not cause a higher incidence of high grade or other prostate cancer. It would have been nice if the author had included a summary of the reasons (or data) that prompted this new warning.
High grade Prostate cancer
posted by Robert on 10 Jun 2011 at 10:34 amI have noticed a disturbing trend regarding drugs that seem to be pushed to market before the long-term effects can be fully discovered. I understand that this is more about the dosage amount than anything else but shouldn’t care be taken by physician’s and others to ensure that any serious side effects are discovered and addressed immediately. I just think that pharma companies are concerned about the bottom line and not the people involved.
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