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Active Ingredient: ALDESLEUK ARCTIUM L BARIUM CA CHIMAPHIL CLEMATIS
Side Effects reported to FDA: 2. View Prostate Adverse Reports
5-alpha reductase inhibitors (5-ARIs): Label Change - Increased Risk of Prostate Cancer
Drugs in the 5-ARI class include finasteride and dutasteride. These drugs are marketed under the brand-names Proscar, Propecia, Avodart, and Jalyn
AUDIENCE: Urology, Family Medicine, Internal Medicine
ISSUE: FDA notified healthcare professionals that the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor (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).
BACKGROUND: The new safety information is based on FDA’s review of two large, randomized controlled trials––the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial. Proscar, Avodart, and Jalyn are approved to improve symptoms of an enlarged prostate gland (benign prostatic hyperplasia or 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.
RECOMMENDATION: 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). See Drug Safety Communication for a Data Summary and additional information.
[06/09/2011 - Drug Safety Communication - FDA]
[06/09/2011 - Q and A's - FDA]
Have Your experienced Prostate Side Effects? You are not alone. Many patients report unusual symptoms after using Prostate. PatientsVille.com raises awareness about Drug Side Effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.