Are you an Avodart user? If so, be advised: Avodart and other similar medications have been linked to high-grade prostate cancer and other serious sexual side effects including erectile dysfunction, impotence, problems with ejaculation and decreased sperm count. The Defective Drug Litigation Group at our law firm is handling individual litigation nationwide and currently accepting new Avodart side effects cases in all 50 states.
FDA Warning on Avodart
In a press released issued by the U.S. Food & Drug Administration (FDA) on June 9, 2011, the administration announced that Avodart and other 5-alpha reductase inhibitor (5-ARI) drugs will include new cautionary language highlighting data suggesting a link to high-grade prostate cancer tumors. The data comes from two new studies that showed the drugs cut the overall risk of contracting prostate cancer, but boosted the chance of developing the more deadly high-grade tumors. Along with Avodart, 5-ARI medications indicated in the new warnings include Propecia, Proscar and Jalyn.
“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––which evaluated daily use of finasteride 5 mg versus placebo for 7 years and daily use of dutasteride 0.5 mg versus placebo for 4 years, respectively, for the reduction in the risk of prostate cancer in men at least 50 years of age. The trials demonstrated an overall reduction in prostate cancer diagnoses with finasteride 5 mg and dutasteride treatment. This overall reduction was due to a decreased incidence of lower risk forms of prostate cancer. However, both trials showed an increased incidence of high-grade prostate cancer with finasteride and dutasteride treatment.”
What is Avodart?
Marketed and manufactured by GlaxoSmithKline (GSK), Avodart is an FDA-approved medication that treats an enlarged prostate by blocking an enzyme that converts testosterone into dihydrotestosterone (DHT), a hormone responsible for enlarging the prostate. By reducing DHT levels, Avodart helps to shrink the prostate, thereby relieving the symptoms of an enlarged prostate. In addition to its approved usages, Avodart is also commonly used in an ‘off-label’ capacity to treat male pattern baldness and prostate cancer after surgical removal of the prostate.
Avodart Prostate Cancer
Prostate cancer is a disease that starts in the prostate gland, a walnut-sized structure located just under the bladder that makes up part of a man’s reproductive system. The prostate gland produces fluid that makes up part of the semen. Prostate cancer occurs when cells in the prostate gland grow out of control. There are often no early signs of prostate cancer, but some men have reported:
- Delayed or slowed start of urinary stream;
- Dribbling or leakage of urine, most often after urinating;
- Slow urinary stream;
- Straining when urinating, or not being able to empty out all of the urine;
- Blood in the urine or semen;
- Bone pain or tenderness, most often in the lower back and pelvic bones (only when the cancer has spread)
Prostate cancer is most often found in older men. As men age, the prostate may enlarge and block the bladder or urethra, leading to a condition known as benign prostatic hyperplasia (BPH). Although BPH is not cancer, surgery may be needed to correct it. The symptoms of BPH and other issues in the prostate may be similar to those listed above.
Prostate Cancer Treatment
Prostate cancer treatment options depend on the following factors:
- how fast the cancer is growing
- how much the cancer has spread
- to what parts of the body the cancer has spread
- a patient’s overall health
- the benefits and potential side effects of the treatment
For tumors that are still inside the prostate, radiation therapy and radical prostatectomy are common treatment options. “Watchful waiting” is a popular treatment option for older men, and involves an approach where no treatment is given until the tumor gets bigger. Tumors that have grown beyond the edge of the prostate cannot be cured with radiation or surgery, and must be treated with hormones that are designed to slow the cancer’s growth.
Sexual Side Effects of Avodart
To make matters worse, the use of Avodart and other 5-alpha reductase inhibitor (5-ARI) drugs may result in permanent sexual dysfunction in some men. Sexual side effects may include (but are not limited to):
- loss of sexual desire
- erectile dysfunction
- reduced semen volume
Other, non-sexual side effects commonly reported in Propecia users include:
- male breast cancer
- testicular pain