New Study Maintains Propecia Safety and Efficacy

INTERNATIONAL SOCIETY OF HAIR RESTORATION SURGERY MAINTAINS SAFETY AND EFFICACY OF PROPECIA (FINASTERIDE 1MG) FOR MALE HAIR LOSS IS BACKED BY PROVEN SCIENTIFIC DATA

Task force formed to study reports of sexual dysfunction in some men taking Propecia for hair loss

GENEVA, IL. – December 13, 2011. The International Society of Hair Restoration Surgery (ISHRS) – the world’s leading medical authority on hair loss and hair restoration – cautions that recent anecdotal reports of persistent sexual dysfunction by some men who have used finasteride 1mg (Propecia) to treat hair loss should not define the safety and effectiveness of this drug. Propecia is the only oral medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of hair loss in men.

From a scientific standpoint, the ISHRS reports that there are no evidence-based data substantiating the link between finasteride and persistent sexual side effects after discontinued use of the drug in numerous, double blinded, placebo controlled studies conducted evaluating the use of Propecia 1mg for hair loss.

“The health and well being of our patients is the utmost concern of the 900 physician members of the ISHRS – whether prescribing medications like Propecia or performing hair restoration surgery,” said ISHRS President Dr. Jennifer Martinick. “ISHRS members devote an average of 72% of their practices to medically and surgically treating hair loss, and collectively they have treated millions of men around the world suffering from hair loss with finasteride 1mg with virtually no side effects.”

Since receiving FDA approval in December of 1997, 20.5 million and 6.7 million patient-years of exposure using Proscar (finasteride 5mg) and Propecia (finasteride 1mg) respectively are recorded with a low adverse event profile. The ISHRS believes that these are the most current and reliable data available until further studies are conducted.

Sexual dysfunction is a complex disorder, and Dr. Martinick noted that it often can be hard to pinpoint the exact cause – particularly when multiple factors such as nicotine, alcohol, prescription medications, stress, anxiety, fatigue and depression can contribute to erectile dysfunction (ED).

“The incidence of ED in the general population is known to be quite high – as high as 49% in middle-aged and older men according to one study published in 2006 in the Archives of Internal Medicine,” said Dr. Martinick. “That being said, we owe it to our patients to address valid concerns in a scientific manner and to clarify any misleading reports so that men can make informed choices regarding the use of this medication.”

Recently, the ISHRS formed a task force to more closely examine anecdotal reports of sexual dysfunction by some Propecia users who have used the drug to treat hair loss. In addition, the ISHRS has called on the medical communities of dermatologists, hair loss physicians, urologists, endocrinologists and sexual medicine specialists to join in a colloquium to share all data and experiences with finasteride in a fact-based manner.

About the ISHRS
Founded in 1993, the International Society of Hair Restoration Surgery (ISHRS) is a non-profit medical association with a membership of over 900 physicians worldwide dedicated to the advancement of the art and science of hair restoration. The mission of the ISHRS is to achieve excellence in patient outcomes by promoting member education, international collegiality, research, ethics, and public awareness. For more information and to locate a physician, visit www.ishrs.org.

The following are precautions for Propecia provided by the FDA:

Propecia (finasteride) 1 mg tablet

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) March 2010, March 2011 and June 2011

 

June 2011 

Summary View

 

PRECAUTIONS

Increased Risk of High-Grade Prostate Cancer with 5-Alpha Reductase Inhibitors
  • Men aged 55 and over with a normal digital rectal examination and PSA ≤3.0 ng/mL at baseline taking finasteride 5 mg/day (5 times the dose of Propecia) in the 7-year Prostate Cancer Prevention Trial (PCPT) had an increased risk of Gleason score 8-10 prostate cancer (finasteride 1.8% vs placebo 1.1%). Similar results were observed in a 4-year placebo-controlled clinical trial with another 5α-reductase inhibitor (dutasteride, Avodart) (1% dutasteride vs 0.5% placebo). 5α-reductase inhibitors may increase the risk of development of high-grade prostate cancer. Whether the effect of 5α-reductase inhibitors to reduce to reduce prostate volume, or study-related factors, impacted the results of these studies has not been established.

ADVERSE REACTIONS

  • During the 4- to 6-year placebo- and comparator-controlled Medical Therapy of Prostatic Symptoms (MTOPS) study that enrolled 3047 men, there were 4 cases of breast cancer in men treated with Proscar but no cases in men not treated with Proscar. During the 4-year placebo-controlled study that enrolled 3040 men, there were 2 cases of breast cancer in placebo-treated men but no cases in men treated with Proscar. During the 7-year placebo-controlled Prostate Cancer Prevention Trial (PCPT) that enrolled 18,882 men, there was 1 case of breast cancer in men treated with Proscar, and 1 case of breast cancer in men treated with placebo. The relationship between long-term use of finasteride and male breast neoplasia is currently unknown.
  • The PCPT trial was a 7-year randomized, double-blind, placebo-controlled trial that enrolled 18,882 healthy men ≥55 years of age with a normal digital rectal examination and a PSA ≤3.0 ng/mL. Men received either Proscar (finasteride 5 mg) or placebo daily. Patients were evaluated annually with PSA and digital rectal exams. Biopsies were performed for elevated PSA, an abnormal digital rectal exam, or the end of study. The incidence of Gleason score 8-10 prostate cancer was higher in men treated with finasteride (1.8%) than in those treated with placebo (1.1%). In a 4-year placebo-controlled clinical trial with another 5α-reductase inhibitor (dutasteride, Avodart), similar results for Gleason score 8-10 prostate cancer were observed (1% dutasteride vs 0.5% placebo). The clinical significance of these findings with respect to use of Propecia by men is unknown.
  • No clinical benefit has been demonstrated in patients with prostate cancer treated with Proscar. Proscar is not approved to reduce the risk of developing prostate cancer.

 

March 2011

Summary View

ADVERSE REACTIONS

Postmarketing Experience
  • depression

 

March 2010

Summary View

PRECAUTIONS

Drug/Laboratory Test Interactions Other
  • Studies with Proscar showed it may also cause decreases in serum PSA in the presence of prostate cancer.  Any confirmed increases in PSA levels from nadir while on Propecia may signal the presence of prostate cancer and should be carefully evaluated, even if those values are still within the normal range for men not taking a 5α reductase inhibitor. Non-compliance to therapy with Propecia may also affect PSA test results.

MEDICATIONS GUIDE

What are the possible side effects of Propecia?
  • Because Propecia decreases PSA levels, changes in PSA levels will need to be carefully evaluated by your doctor(s). Any increase in follow-up PSA levels from their lowest point should be carefully evaluated even if the test results are still within the normal range for men not taking Propecia. You should also tell your doctor if you have not been taking Propecia as prescribed because this may affect the PSA test results. For more information, talk to your doctor.

 

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