June 10, 2011 – The U.S. Food & Drug Administration (FDA) has issued a press release stating that the Warnings and Precautions labeling for Proscar and other 5-alpha reductase inhibitor (5-ARI) drugs has been changed to include information about the increased risk of high-grade prostate cancer associated with the medications. FDA is recommending that users perform appropriate evaluations to rule out other urological conditions that might mimic benign prostatic hyperplasia (BPH).
Proscar Prostate Cancer Update 3/19/12: Canadian health officials are warning the public that Propecia, Proscar and Avodart may be linked to an increased risk for developing high-grade prostate cancer. New information regarding this risk has been added to Canadian warning labels for these drugs. Click here to learn more.
Proscar Lawsuit Update 2/16/12: More than 50 people from 22 states have joined a lawsuit against Merck & Co. and its subsidiaries for failing to warn the public about the dangerous side effects associated with their male pattern baldness drugs. The complaint alleges that Propecia and Proscar, which contain the active ingredient finasteride, cause an “increased risk of persistent and/or serious and dangerous side effects.” Click here to learn more.
Free Proscar Case Evaluation: If you or a loved one has been diagnosed with prostate cancer after using Proscar, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
What’s the problem?
The new Proscar label change is based on the FDA’s review of the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial. These studies evaluated daily use of finasteride 5 mg for seven years and dutasteride for four years, respectively, in men at least 50 years of age. The trials demonstrated an overall reduction in prostate cancer diagnoses with the medications, which was attributed to a decreased incidence of lower forms of prostate cancer. However, both trials showed an increased incidence of high-grade prostate cancer with finasteride and dutasteride treatment.
“The results of the PCPT showed that men on the finasteride arm had a 26% overall lower risk of being diagnosed with prostate cancer when compared to the placebo arm (p<0.0001). The reduction in risk of prostate cancer was limited to Gleason score (GS) 6 or lower prostate cancers. However, there was an increased incidence of GS 8-10 prostate cancers with finasteride versus placebo (1.8% versus 1.1%, respectively). … The results of the REDUCE trial showed that men on dutasteride had a 23% overall lower risk of being diagnosed with biopsy detectable prostate cancer when compared to men on placebo (p<0.0001). This overall risk reduction was limited to a decrease in GS 6 or lower prostate cancers. In contrast, there was an increased incidence of GS 8-10 cancers with dutasteride versus placebo (1% versus 0.5%, respectively).”
Proscar High-Grade Prostate Cancer
High-grade prostate cancer is a type of cancer that has an appearance least like normal prostate scales. It is the most deadly type of prostate cancer since it is aggressive and grows extremely fast, even into surrounding areas such as lymph nodes and bones. High-grade cancer cells are characteristically large, hard to treat, and reappear more frequently. Unfortunately, high-grade prostate cancer does not initially cause symptoms. By the time symptoms do occur, the disease may be full-blown and spreading to other parts of the body. Signs and symptoms of high-grade prostate cancer include:
- Urinary problems (not being able to urinate; having a hard time starting or stopping the flow of urine; needing to urinate often, especially at night; weak flow of urine; urine flow that starts and stops; pain or burning during urination)
- Difficulty having an erection
- Blood in the urine or semen
- Frequent pain in the lower back, hips, or upper thighs
Prior to initiating therapy with Proscar, it is advised that physicians perform tests on potential patients to rule out other urological conditions – including prostate cancer – that could mimic the symptoms of BPH. Proscar is approved to treat symptoms of an enlarged prostate gland (benign prostatic hyperplasia or BPH), as well as to reduce the risk of urinary retention or surgery related to an enlarged prostate. Other drugs in the 5-alpha reductase inhibitor (5-ARI) class include Propecia, Avodart, and Jalyn.
Do I have a Proscar Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Proscar lawsuits. We are handling individual litigation nationwide and currently accepting new prostate cancer cases in all 50 states.