Propecia FDA Warning

In June 2011, the U.S. Food & Drug Administration (FDA) issued a press release indicating that Propecia and other drugs used to treat baldness may increase the risk of the most serious form of prostate cancer. Federal health officials issued a safety alert stating that a group of drugs known as 5-alpha reductase inhibitors (5-ARIs) – which are sold under the names Propecia, Proscar, Avodart and Jalyn – may boost the chance of developing high-grade prostate cancer. The warning is based on the FDA’s review of two large studies which showed that the drugs increased the risk of developing high-grade tumors.

Free Propecia Case Evaluation: If you or a loved one has developed prostate cancer or any other serious side effect after undergoing treatment with Propecia, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.

Propecia Prostate Cancer

On June 9, 2011, the FDA informed healthcare professionals that the warning labels for Propecia and other drugs in the 5-ARI class had been updated to include new safety information about the risk of being diagnosed with high-grade prostate cancer, the most serious form of the disease. The administration has advised healthcare professionals and patients to be aware of the prostate cancer link, and to carefully weigh the benefits vs. risks prior to beginning or continuing a regimen of 5-ARI treatment.

Propecia contains finasteride, the active ingredient in all 5-ARIs. Finasteride treats male pattern baldness by preventing the conversion of testosterone to dihydrotestosterone (DHT). DHT is a substance in the body that has the potential to shrink hair follicles until they are no longer visible. By doing so, Propecia is supposed to promote and assist in the steady growth of hair in the scalp region.

The move to enhance the warnings on Propecia was based on the agency’s review of two trials – the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial – which analyzed daily use of finasteride 5 mg vs. placebo for seven years and daily use of dutasteride 0.5 mg vs. placebo for four years.

The PCPT was a randomized, double-blind, placebo-controlled trial in 18,882 men over the age of 55 who had normal digital rectal examination and PSA levels. The trial compared the use of finasteride 5 mg to placebo for the reduction in the risk of prostate cancer. Treatment was continued for seven years following randomization or until diagnosis of prostate cancer, initiation of treatment with a 5-ARI, or unacceptable side effects. The results of the PCPT showed that men taking finasteride had a 26% overall lower risk of being diagnosed with prostate cancer than the placebo group. However, there was an increased risk of high-grade prostate cancers with finasteride vs. placebo.

The REDUCE trial was a randomized, double-blind four year study designed to evaluate the safety of dutasteride in reducing the risk of prostate cancer in 8,231 men 50-75 years of age considered to be at increased risk for prostate cancer. The results of the trial showed that men tasking dutasteride had a 23% overall lower risk of being diagnosed with low-grade prostate cancer when compared to test subjects taking a placebo. However, like the PCPT, the REDUCE trial found an increased incidence of high-grade prostate cancer with dutasteride vs. placebo. According to the FDA press release:

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.

Signs and symptoms of Propecia-induced high-grade prostate cancer include:

• trouble urinating
• decreased force in the stream of urine
• blood in the urine
• blood in the semen
• swelling in the legs
• discomfort in the pelvic area
• bone pain

Side Effects of Propecia

In addition to the increased risk for high-grade prostate cancer, Propecia has also been linked to a host of serious sexual side effects including:

• less desire for sex
• difficulty in achieving an erection (erectile dysfunction)
• decrease in the amount of semen
• problems with ejaculation
• gynecomastia
• impotence
• testicular pain
• male breast cancer

Some men have also reported various mental side effects associated with Propecia use that include:

• depression
• anxiety
• insomnia
• memory loss
• slurring of speech
• dissociative states

State laws establish independent statutes of limitations for which a Propecia prostate cancer claim can be filed. Lawsuits of this type are typically product liability claims because the manufacturer failed to provide an adequate warning about the risk of prostate cancer. Most Propecia prostate cancer lawsuits include causes of action for strict liability, negligence, and breach of warranty. Because state laws create a deadline for filing a claim, a man who believes he contracted high-grade prostate cancer because of Propecia should contact a defective drug lawyer as soon as possible.

Do You have a Propecia 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 Propecia prostate cancer lawsuits. We are handling individual litigation nationwide and currently accepting new Propecia prostate cancer cases in all 50 states.