On June 9, 2011, the U.S. Food & Drug Administration (FDA) issued a press release informing the public of new safety information for Jalyn and other medications in the 5-alpha reductase inhibitor (5-ARI) class. Men who take these drugs may be at an increased risk of developing a serious form of cancer known as high-grade prostate cancer. Additionally, 5-ARI drugs like Jalyn have been linked to serious sexual side effects including erectile dysfunction, impotence, low libido and gynecomastia.
Jalyn 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.
Free Jalyn Case Evaluation: If you or a loved one has been injured by Jalyn, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
Jalyn FDA Warning
Prompted by the results of two large studies - the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) Trial - the FDA said it was requiring the labels of the following medications to be updated to include the risk of high-grade prostate cancer:
The studies found that these drugs paradoxically decreased the chance of getting lower-risk forms of prostate cancer by as much as 26%, but slightly raised the risk of a more severe type of prostate cancer that grows and spreads more rapidly.
“This risk appears to be low, but healthcare professionals should be aware of this safety information, and weigh the known benefits against the potential risks when deciding to start or continue treatment with 5-ARIs in men,” the FDA said.
Jalyn (generic: dutasteride and tamsulosin) is an FDA-approved prescription medication distributed by GlaxoSmithKline (GSK) for the treatment of an enlarged prostate (known medically as benign prostatic hyperplasia). The drug works by blocking the conversion of testosterone into dihydrotestosterone (DHT), a male sex hormone responsible for enlarging the prostate. Because DHT is responsible for enlarging the prostate, using Jalyn to reduce DHT levels can help shrink an enlarged prostate and relieve symptoms of benign prostatic hyperplasia.
Benign Prostatic Hyperplasia (BPH)
As a man ages, the prostate goes through two separate periods of growth. The prostate initially begins to grow in early puberty, when it nearly doubles in size. Then around the age of 25, the prostate enters a second phase of growth that often results in benign prostatic hyperplasia (BPH) later in life. BPH may compress the urethra which courses through the center of the prostate, impeding the flow of urine from the bladder through the urethra to the outside. It can cause urine to back up in the bladder (retention), leading to the need to urinate frequently during the day and night. Additional signs and symptoms of BPH include (but are not limited to):
- Hesitancy/straining - When the urethra is obstructed, it is often difficult to start urinating despite the urge.
- Weak stream/intermittency - Flow of urine may be slow or diminished. Urination may be characterized by a repetitive pattern that requires additional straining.
- Nocturia (nighttime frequency) - The inability to sleep through the night without having to get up to urinate.
- Urgency - The sudden and intense urge to urinate that results from having a hypersensitive bladder.
Jalyn Prostate Cancer
Prostate cancer is one of the most common types of cancer found in men. It usually grows slowly and initially remains confined to the prostate, a small gland in a man’s body that produces seminal fluid that nourishes and transports sperm. While some types of cancer grow slowly and may need minimal treatment, jalyn-induced high-grade prostate cancer is aggressive and can spread quickly. A measure of prostate cancer aggressiveness is the Gleason score, which is calculated by a trained pathologist observing prostate biopsy specimens under the microscope. Telltale symptoms of prostate cancer include:
- problems during urination
- difficulty achieving an erection
- painful ejaculation
- semen in the blood
- pelvic discomfort
- persistent back and/or hip pain
- Swelling in the legs
- Swollen lymph nodes
According to the American Cancer Society, nearly 200,000 new cases of prostate cancer are diagnosed each year. Sadly, a high percentage of these cases will result in the death of the patient. The estimated lifetime risk of being diagnosed with the disease is 17.6% for Caucasians and 20.6% for African Americans. The lifetime risk of death from prostate cancer similarly is 2.8% and 4.7%, respectively. Considering these figures, it is safe to say that prostate cancer is likely to impact the lives of a significant proportion of men that are alive today.
Sexual Side Effects of Jalyn
In addition to the prostate issues linked to Jalyn, a significant number of men reported sexual side effects including:
- less desire for sex
- difficulty in achieving an erection (erectile dysfunction)
- decrease in the amount of semen
- problems with ejaculation
- testicular pain
- male breast cancer
Individual Jalyn lawsuits are currently being investigated around the country in an attempt to hold GSK accountable for its negligence. These lawsuits claim that the company’s warnings led men to think that any potential side effects would go away once the treatment was discontinued. If you’ve suffered from any of the side effects listed in this article after taking Jalyn, contact our attorneys today.
Related Cancer Lawsuit: Morcellator Cancer Lawsuit
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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 Jalyn lawsuits. We are handling individual litigation nationwide and currently accepting new prostate cancer cases in all 50 states.