On June 9, 2011, the U.S. Food and Drug Administration (“FDA”) announced that it would revise the labeling on all drugs that contain 5-alpha reductase inhibitors (“5-ARIs”).The new labeling warns consumers that taking these drugs puts them at an increased risk of developing high-grade prostate cancer.  Drugs such as Proscar contain 5-ARIs, which inhibit the conversion of the male hormone, testosterone, into dihydrotestosterone (“DHT”), which can cause enlarged prostates. Proscar helps decrease DHT levels, shrinking the prostate over time, and works to alleviate the symptoms of an enlarged prostate, which include difficulty urinating, getting up during the night to urinate, decreased urinary flow, and hesitation at the start of urination. Proscar is also used to reduce the risk of urinary retention or surgery related to an enlarged prostate.

FDA Responds to Studies Concluding that Proscar Leads to Prostate Cancer

High-grade prostate cancer is a quick spreading form of prostate cancer; the appearance of the cancer cells is vastly different from normal prostate cells. It is also one of the most deadly forms of prostate cancer because of its aggressive nature, and the cancerous cells’ ability to enter into surrounding areas such as bones and lymph nodes. High-grade cancer cells are usually harder to treat and reappear more frequently.

After reviewing randomized controlled studies, the FDA issued a Drug Safety Community Publication, which modified the labels of all drugs containing 5-ARIs. These studies found that daily use of 5-ARIs for a prolonged period of time lowered the risk of less aggressive forms of prostate cancer, but increased the likelihood of developing high-grade prostate cancer. The two trials conducted by the FDA involved 27,000 men, 50 years of age or older, who used either Avodart or Proscar for several years. As a direct result of the two trials conducted by the FDA, the labels of all FDA-approved 5-ARI’s now will include new information and warnings that these drugs may increase the risk of high-grade prostate cancer. Additionally, the new labels will also provide information to warn consumers that 5-ARIs are not approved for the prevention of prostate cancer. In the Drug Safety Communication, the FDA did not deny that 5-ARIs are beneficial for the treatment of enlarged prostates but maintained that consumers should be aware of the potential risks.

Proscar Lawsuits

If you or a loved one took Proscar and have been diagnosed with prostate cancer, you may be eligible to file a Proscar lawsuit seeking compensation for your injuries and reimbursement of your expenses.  Contact one of our Proscar injury attorneys today for a free assessment of your potential Proscar lawsuit and find out if you are eligible for compensation. The lawyers at Bernstein Liebhard LLP have extensive litigation experience, and have recovered billions of dollars for their clients. In addition to being staunch advocates for your claim, our Proscar injury lawyers also provide personal attention to guide you through the complex litigation process.

Published November 17, 2011 by