Propecia Linked to Prostate Cancer, FDA Says
By Andrea Gressman
Healthcare providers have been warned by the U.S. Food and Drug Administration that a class of drugs known as 5-alpha reductase inhibitors (5-ARIs), like Propecia, has a new adverse side effect. The FDA warns that these drugs pose an increased risk of developing high-grade prostate cancer in men. While the FDA states that the side effect risk of Propecia prostate cancer is low, it is present and healthcare providers should be aware of the new safety considerations of these drugs.
The drugs included in this warning are finasteride and dutasteride. Dutasteride is marketed as Avodart while finasteride is marketed as either Proscar or Propecia. Propecia is one of the biggest brand names affected by this warning. The FDA states that about 5 million men have received prescriptions for 5-ARIs with 3 million of those being between the ages of 50 and 79. This latter group is already at a higher risk for prostate cancer due to their age and the drugs may exacerbate this risk.
Propecia is a low dose (1 mg) of finasteride manufactured by Merck. The drug has been approved to treat hair loss in male patients. The new warning by the FDA throws the safety of Propecia into question.
The FDA has based their warning of Propecia prostate cancer on two separate studies. These studies were two large, randomized and controlled clinical trials. These two trials were the Prostate Cancer Prevention Trial and the Reduction by Dutasteride of Prostate Cancer Events. The first clinical trial tested the use of finasteride (Proscar and Propecia) in 5 mg doses for 7 years. The latter study tested a dose of 0.5 mg of dutasteride against a placebo for a span of 4 years. Both of these studies looked for a reduction in the side effect risk of prostate cancer in male patients over the age of 50.
The good news of both studies was that the drugs showed an overall decreased side effect risk of prostate cancer against a placebo. While the overall side effect risk of prostate cancer was down, the incidence of a more advanced form of cancer was higher in both clinical trials. The high-grade prostate cancer risk was higher with both finasteride and dutasteride use.
With the revelation of this new information, healthcare providers must take new aspects of their patients’ urological health into consideration before administering 5-ARIs like Proscar, Propecia or Avodart. Again, while the side effect risk factor is currently believed to be small, those at a high risk for high-grade prostate cancer should perhaps seek alternate treatment and consult their physician before beginning these medications.
With this new revelation, there will likely be a new increase in in Propecia injury lawsuits filed as there was no warning of these prostate cancer side effects before. Many Propecia users that have developed these types of side effects probably never made the connection between the two until now.
There have been additional side effects associated to Propecia use as well. Some of these include the following:
* Anxiety
* Decreased sperm count
* Depression
* Erectile dysfunction (ED)
* Genital Shrinkage
* Impotence
* Loss of sex drive
* Low libido
* Male breast cancer
* Memory loss
* Peyronie’s disease
* Prostate cancer
* Testicular pain
If you have experienced a Propecia side effect, including prostate cancer as mentioned above, anxiety, depression, decreased sperm count, erectile dysfunction (ED), impotence, genital shrinkage, loss of sex drive, male breast cancer, low libido, memory loss, or testicular pain, you are not alone. Visit the Propecia Loss of Sex Drive, Sexual Dysfunction Class Action Lawsuit Settlement Investigation page to receive your free consultation with a qualified Propecia lawsuit lawyer.
Updated December 11th, 2012
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One thought on Propecia Linked to Prostate Cancer, FDA Says
I hope everyone that has had issues with Propecia report it to the FDA so they can start documenting cases. I contacted them and basically said in my email. “I wish they would take a closer look at Propecia, because it had ruined my life…..and if they wanted to hear my story I’d email it to them.” They sent a very nice and understand email back and wanted to hear more…..I think more people should email them.