Trials show an increased incidence of high grade prostate cancer with finasteride and dutasteride treatment.
New safety information has been released based on the FDA's review of two large clinical trials: "The Prostate Cancer Prevention Trial "(PCPT) and "Reduction by Dutasteride of Prostate Cancer Events" (REDUCE) trial.
Both trials showed an increased incidence of high-grade prostate cancer with finasteride and dutasteride treatment. These medications are classified as 5-alpha reductase inhibitors (5-ARIs). Per the FDA, "drugs in the 5-ARI class are finasteride and dutasteride. These drugs are marketed under the brand-names Proscar, Propecia, Avodart, and Jalyn."
How many men are at risk? Reports show that approximately 5 million men received a prescription for a 5-ARI between years 2002 and 2009. It is estimated that approximately 3 million of these patients were between 50 and 79 years of age (1). The American Urological Association revised its guidelines and now recommends that baseline screening be considered in men at 40 years of age instead of 50 years. Men that are in high-risk groups, African-Americans or those with a family history should be checked on a regular basis.
It is important to note that the increased risk of prostate cancer was reported with the more serious type of prostate cancer defined as "GS 8-10 Prostate Cancers." It is suggested that risk for this form of "high-grade cancer" appears to be low. Obviously, for individuals that incurred this form of "high-grade cancer," the risk was too high.
It is becoming obvious that maybe some of these prescription medications are not as safe as previously thought. It is virtually impossible to turn on the television and not see a law firm commercial regarding this medication or that. This is why it is important to choose a health care provider that you trust and with whom you can discuss your health concerns.
Outside North America, physicians and health care professionals rely more heavily on natural products, known in the U.S. as dietary supplements. Pharmaceutical revenues for a respective medication are much higher in North America in comparison to revenue generated outside of North America. In addition, the number of insurance carriers covering individuals and willing to pay for expensive prescription medications is extremely limited or simply not available.
"Proscar, Avodart, and Jalyn are FDA-approved 5-ARIs to improve symptoms of an enlarged prostate gland (benign prostatic hyperplasia or BPH). Proscar and Avodart are also FDA approved to reduce the risk of urinary retention or surgery related to an enlarged prostate (2)." "Propecia is an FDA-approved 5-ARI to treat male pattern hair loss (3)."
Outside North America, plant sterols or beta-sitosterol have been relied upon for the relief of BPH or the symptoms of an enlarged prostate for decades. There is no disputing that the symptoms of an enlarged prostate or BPH drastically affect daily living. Tens of thousands of men have discovered that the natural ingredient beta-sitosterol can actually address these symptoms without the side effects of prescription medications. For years the medical community recommended saw palmetto to address the symptoms of an enlarged prostate. However, in 2006 a study published in the New England Journal of Medicine demonstrated that taking saw palmetto for an enlarged prostate was no more effective than a placebo. For men that want to try non-SOY, non-GMO-derived beta-sitosterol for the symptoms of an enlarged prostate, there is Best Prostate at www.bestprostate.com or www.naturalprostateformula.com.
1. Vector One®: Total Patient Tracker (TPT). Years 2002-2009. Data extracted 5-24-11.
2., 3. www.fda.gov/Drugs/DrugSafety/ucm258314.htm