5-Alpha Reductase Inhibitor (5-ARI) Drugs may increase Prostate, Male Breast Cancer and Erectile Dysfunction Risk
Prostate Cancer, Male Breast Cancer or Erectile Dysfunction sufferers that used Propecia, Avodart, Proscar or Jalyn, the medication, known as a 5-alpha reductase inhibitor (5-ARI) may be to blame. Parker Waichman LLP is offering free case evaluations to victims of 5-ARI victims and their families. Contact our defective drug lawyers today by completing our online form or calling us at 1-800-YOURLAWYER (1-800-968-7529).
In June 2011, the U.S. Food & Drug Administration (FDA) informed healthcare professionals that the Warnings and Precautions section of the labels for these drugs was being updated to include information about their association with high-grade prostate cancer, a more serious and aggressive form of the disease. In August 2011, Canadian regulators announced that labels of a 5-alpha reductase inhibitor product (finasteride) sold in Canada would be updated to include information regarding their possible association with male breast cancer.
Health Canada, has stated that male breast cancer has been reported in a small number of patients worldwide with both the 1 mg and 5 mg formulations of finasteride, though most have been associated with the 5mg formulation. Health Canada has advised that men taking finasteride contact their doctors should they experience breast enlargement, breast lumps, pain or tenderness, nipple discharge, or any other changes while taking the drug.
If you or a loved one were diagnosed with high-grade prostate cancer or have been recently diagnosed with male breast cancer while taking Proscar, Propecia, Avodart or Jalyn, you may be entitled to compensation. The defective drug lawyers at Parker Waichman LLP are experienced in defective drug litigation and are offering free lawsuit evaluations to 5-ARI victims and their families. To learn how our 5-ARI (5-alpha reductase inhibitor) lawyers can help you, we urge you to contact us today.
Proscar, Propecia, Avodart or Jalyn users and High-Grade Prostate, Male Breast Cancer Risk
Proscar (finasteride 5 mg), Avodart (dutasteride), and Jalyn (dutasteride and tamsulosin) 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 (finasteride 1 mg) is approved to treat male pattern hair loss. According to the FDA, approximately 5 million male patients received a prescription for a 5-ARI medication between years 2002 to 2009. Of these, nearly 3 million patients were between the ages of 50 and 79 years old.
In a Drug Safety Community Publication issued on June 9, 2011, the FDA said the decision to modify the labels of 5-ARIs was based on its review of two large, randomized controlled trials–the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial.
Together these trials involved 27,000 men 50 years of age or older who used either Proscar or Avodart for several years. According to the FDA, while both trials demonstrated an overall reduction in prostate cancer diagnoses with use of the drugs, this was mainly due to a decreased incidence of lower risk forms of prostate cancer. Both trials, in fact, saw an increased incidence of high-grade prostate cancer with finasteride and dutasteride treatment.
As a result of these two studies, the labels of all FDA-approved 5-ARIs will now include new information that they may increase the risk of high-grade prostate cancer. The product labeling will also state that 5-ARIs are not approved for the prevention of prostate cancer. The labeling of Propecia, although not a treatment for enlarged prostate, was also changed to reflect the possibility of an increased risk of high-grade prostate cancer because Propecia contains 1 mg of finasteride, the same active ingredient in Proscar.
High-grade prostate cancer is an aggressive type of prostate cancer, meaning it grows and spreads faster compared to low-grade prostate cancer. According to the FDA, high-grade prostate cancer is a serious disease, but accounts for a small portion of all diagnosed prostate cancers.
In its Drug Safety Communication, the FDA said it continues to believe that the benefits of 5-ARIs in treating enlarged prostate still outweighs their risks. The FDA said men taking these drugs should consult a healthcare professional to discuss their risks and benefits. Men should not stop taking their medication unless directed to do so by a healthcare professional.