Suicidal Ideaton Associated with Finasteride Use in Young Men, Says New Study in Leading Pharmacology Journal

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Suicidal Ideaton Associated with Finasteride Use in Young Men,

Says New Study in Leading Pharmacology Journal

 

SOMERSET, N.J., July 23, 2015 – New research in a leading pharmacology journal concludes that young men who take finasteride for hair loss may be at risk of contemplating suicide.

The study, published in the July issue of Pharmacotherapy and titled “Persistent Sexual Dysfunction and Suicidal Ideation in Young Men Treated with Low-Dose Finasteride,” analyzed 4,910 adverse-event reports involving low-dose finasteride use among men 18 to 45 years old that were submitted to the U.S. Food and Drug Administration between 1998 and 2013.

Researchers found that 11.8% of those reports (577 cases) involved persistent sexual dysfunction (SD) and 7.9% (39 cases) involved suicidal ideation (SI).

“Approximately 60% of the SD events were serious in nature, corresponding to disability (43.5%), required intervention (18.3%), hospitalization (9.9%), life-threatening events (5.5%), and patient death (1.7%),” they report. “Among men who experienced SD and SI, 88% of the SI events were serious (disability [36.7%], hospitalization [20%], life-threatening events [16.7%], and required intervention [13.3%]).”

“Persistent [sexual dysfunction] might be a potential risk of low-dose finasteride for androgenic alopecia therapy in young men, and this risk might contribute to [suicidal ideation],” concludes the study’s lead author, Ayad Ali, a pharmacoepidemiologist in the Global Patient Safety division of Eli Lilly and Company.

“Our findings provide a strong hypothesis for pharmacoepidemiologic studies to further examine this association.”

“This study is further evidence that finasteride most likely plays a role in not only devastating sexual health in a subset of otherwise healthy men, but in some cases leads to suicide,” added PFS Foundation CEO Dr. John Santmann. “It’s critical that health care professionals be aware of the numerous risks when considering finasteride therapy for patients.”

PFS has been reported to occur in men who have taken the prescription drug finasteride to treat hair loss (under the brand name Propecia and generics), or enlarged prostates (Proscar and generics).

Reported symptoms include loss of libido, erectile dysfunction, depression, suicidal ideation, anxiety, panic attacks, Peyronie’s disease, penile shrinkage, gynecomastia, muscle atrophy, cognitive impairment, insomnia, severely dry skin, and tinnitus. The condition often has a life-altering impact on victims and their families, such as job loss and the breakup of marriages and romantic relationships.

In March 2015, the U.S. National Institutes of Health listed PFS on its Genetic and Rare Diseases Information Center, noting that “some patients who have taken finasteride have referred to side effects such as sexual dysfunction and depression (sometimes severe)… Studies sponsored by the NIH and other organizations are underway to better understand the effects of 5-alpha reductase inhibitor drugs.”

Three months later, a study published in the Journal of the American Medical Association (JAMA), found that, of the 34 clinical trials conducted on finasteride, none adequately reported on sexual side effects.

“People who take or prescribe the drug assume it’s safe, but there is insufficient information to make that judgment,” said the study’s lead author, Steven Belknap, of the Northwestern University Feinberg School of Medicine.

Also in June, a study published in Hormone Molecular Biology and Clinical Investigation showed that finasteride increases the severity of erectile dysfunction and decreases testosterone levels in men with benign prostatic hyperplasia.

“Our findings suggest that finasteride therapy is associated with undesirable and, in some cases, detrimental sexual side effects and reduced quality of life,” said the study’s lead investigator, Abdulmaged M. Traish, professor of urology at Boston University School of Medicine.

About the PFS Foundation

Headquartered in Somerset N.J., the Post-Finasteride Syndrome Foundation was established in July 2012 as a 501(c)(3) organization, with private grants from families in the U.S. and abroad. Tax-deductible financial donations to the nonprofit organization can be made via PFSFoundation.org, which also houses patient-recruitment information on active clinical studies, published research, research goals, and media reports about PFS.  In July 2015, the PFS Foundation partnered with the Southwest Brain Bank in the Department of Psychiatry at the Texas Tech University El Paso. The mission of the brain bank is to function as a donation site for post-mortem human brain and spinal cord tissue of PFS patients, and study that matter in order to better understand the pathology and etiology of the condition.

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Contact

Philip Roberts
Post-Finasteride Syndrome Foundation
proberts@pfsfoundation.org
(856)425-6046

 

Southwest Brain Bank Launches PFS Brain and Spinal Cord Donation Program

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Southwest Brain Bank Launches Post-Finasteride Syndrome

Brain and Spinal Cord Donation Program

 

SOMERSET, N.J., July 15, 2015 – The Southwest Brain Bank (SWBB) in the Department of Psychiatry at the University of Texas Health Science Center in San Antonio has received its first donation of the brain and spinal cord of a post-finasteride syndrome (PFS) patient and formed a program to collect and study post-mortem human brain and spinal cord tissue in additional patients with PFS.

The purpose of this program is to better understand the pathology and etiology of PFS, and to better understand the effects of finasteride on the neuroanatomy and neurochemistry of the brain and spinal cord in PFS patients.

Brain and spinal cord tissue that has been donated to the SWBB will be stored in a centralized repository. Available specimens will be distributed to researchers throughout the world who are interested in studying PFS. The precious gift of brain and spinal cord donation will be provided to scientists in their efforts to study the cause and develop new treatments for PFS.

There are two ways to make a donation:

  1. You can make arrangements with the SWBB to donate after death. If you choose this approach, please contact the SWBB to process the authorizations and informed consent.
  2. Family members of deceased PFS patients may also donate their loved one’s brain and spinal cord after their death to the SWBB. As part of the donation, the family member(s) will be interviewed for a history of their loved one, including medical history, educational and occupational history, and history of cognitive, behavioral and mood symptoms. This donation is time critical. The SWBB must receive the donation within 36 hours after death and the brain cannot be embalmed or chemically fixed in any way.

The identity of each potential donor, actual brain donor and donor family will remain strictly confidential. All publication of findings are de-identified (without name and identifiable details) unless the SWBB has received permission from the family to publicize the subject’s participation.

If you would like additional information, please contact Peter Thompson, M.D. at the SWBB.

Limited funds are available from the Post-Finasteride Syndrome Foundation to cover out-of-pocket costs associated with initial neuropathological specimen cryopreservation, handling and shipment to the SWBB.

About the Southwest Brain Bank

The Southwest Brain Bank is a research organization that collects, studies, and distributes brain tissue to scientists that study mental disorders.

About Post-Finasteride Syndrome

PFS has been reported to occur in men who have taken the prescription drug finasteride to treat hair loss (under the brand name Propecia and generics), or enlarged prostates (Proscar and generics).

Symptoms include loss of libido, erectile dysfunction, depression, anxiety, panic attacks, Peyronie’s disease, penile shrinkage, gynecomastia, muscle atrophy, cognitive impairment, insomnia, severely dry skin, and tinnitus. The condition often has a life-altering impact on victims and their families, such as job loss and the breakup of marriages and romantic relationships.

In March 2015, the U.S. National Institutes of Health listed PFS on its Genetic and Rare Diseases Information Center, noting that “some patients who have taken finasteride have referred to side effects such as sexual dysfunction and depression (sometimes severe)… Studies sponsored by the NIH and other organizations are underway to better understand the effects of 5-alpha reductase inhibitor drugs.”

About the PFS Foundation

Headquartered in Somerset N.J., the PFS Foundation was established in July 2012 as a 501(c)(3) organization, with private grants from families in the U.S. and abroad.  Tax-deductible financial donations to the nonprofit organization can be made via PFSFoundation.org, which also houses patient-recruitment information on active clinical studies, published research, research goals, and media reports about PFS.

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Contact

Philip Roberts
Post-Finasteride Syndrome Foundation
proberts@pfsfoundation.org
(856)425-6046

Number of Nations Logging onto PFS Foundation Website Rises 22% in 2014

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Number of Nations Accessing Post-Finasteride Syndrome Foundation Website Rises 22% in 2014

Overall Traffic Jumps 64% vs. 2013

SOMERSET, N.J., Jan. 6, 2015 – The number of nations that logged onto the Post-Finasteride Syndrome Foundation website jumped 22 percent in 2014, according to Google Analytics.

In all, users in 157 countries—or 81 percent of the world (as defined by the 195 nations recognized by the U.S. Department of State)—accessed information on the condition via PFSFoundation.org, versus 129 countries during the period from the website’s launch in August 2012 through 2013.

Visits from outside the U.S. comprised 54 percent of the site’s total annual traffic in 2014.

Additionally, the total number of unique visitors to the site rose 64 percent in 2014 compared to 2013.

Separately, between June 2009 and June 2014, via its MedWatch program, the U.S. Food and Drug Administration received reports of adverse finasteride events from patients and health care professionals in 33 nations outside the U.S., including the U.K., Japan, France, Germany, Canada, Denmark, China, Italy, Spain and Israel.

PFS has been reported to occur in men who have taken the prescription drug finasteride to treat hair loss (under the brand name Propecia and generics), or enlarged prostates (Proscar and generics).

Reported symptoms include loss of libido, erectile dysfunction, depression, suicidal ideation, anxiety, panic attacks, Peyronie’s disease, penile shrinkage, gynecomastia, muscle atrophy, cognitive impairment, insomnia, severely dry skin, and tinnitus. The condition often has a life-altering impact on victims and their families, such as job loss and the breakup of marriages and romantic relationships, while also being linked to suicides.

“At this current rate of expanding awareness, we’re likely to see users from most every nation on earth educating themselves on PFS before the decade is out,” said PFS Foundation CEO Dr. John Santmann.

Following are analytics surrounding PFSFoundation.org use during 2014:

Site popularity by nation (top 50 of 157)

1: USA
2: United Kingdom
3: Germany
4: Canada
5: Japan
6: Brazil
7: Italy
8: Australia
9: Turkey
10: India
11: Spain
12: Ireland
13: Netherlands
14: Sweden
15: Switzerland
16: South Korea
17: Poland
18: France
19: Norway
20: Argentina
21: Finland
22: Israel
23: Belgium
24: Austria
25: Greece
26: Croatia
27: Singapore
28: Portugal
29: Denmark
30: Mexico
31: New Zealand
32: Iran
33: Thailand
34: South Africa
35: Hong Kong
36: Russia
37: Indonesia
38: Philippines
39: United Arab Emirates
40: Chile
41: Pakistan
42: Slovenia
43: Romania
44: Saudi Arabia
45: China
46: Malaysia
47: Serbia
48: Taiwan
49: Colombia
50: Uruguay

Site popularity by U.S. states (top 25 of all 50 + Washington, DC)

1: California
2: New York
3: Texas
4: Massachusetts
5: Florida
6: Pennsylvania
7: Illinois
8: New Jersey
9: Kentucky
10: Nevada
11: Michigan
12: Georgia
13: Virginia
14: Ohio
15: Washington
16: District of Columbia
17: North Carolina
18: Tennessee
19: Maryland
20: Minnesota
21: Connecticut
22: Colorado
23: Oregon
24: Arizona
25: Indiana

Site popularity by language (top 25 of 116*)

1: English
2: German
3: Portugeuse
4: Japanese
5: Turkish
6: Italian
7: Spanish
8: Dutch
9: Polish
10: French
11: Swedish
12: Korean
13: Norwegian
14: Greek
15: Finish
16: Danish
17: Chinese
18: Hebrew
19: Russian
20: Danish
21: Hungarian
22: Croatian
23: Slovene
24: Arabic
25: Thai

*Includes different national varieties, such as American English, British English and Australian English.

Top 10 most popular landing pages

1: Home page

2: Syndrome Overview

3: Daniel Stewart memorial

4: Medical Awareness: Doctors Begin Recruiting PFS Patients for Research Studies

5: Published PFS Clinical Research

6: News release: Clinical Study of Post-Finasteride Syndrome Launched at Brigham and Women’s Hospital

7: News release: Clinical Study of Post-Finasteride Syndrome Launched at Baylor College of Medicine

8: PFS Foundation News page

9: PFS Clinical Research Initiatives

10: Donate

Users by age group

  • 25-34: 33.5%
  • 18-24: 27.5%
  • 35-44: 15.5%
  • 45-54: 12.5%
  • 55-64: 5.5%
  • 65+: 5.5%

Users by gender

  • Male: 54.15%
  • Female: 45.85%

 

Following, in order of popularity, are the nations from which patients and health care professionals filed adverse finasteride events to the FDA between June 2009 and June 2014:

All 34 countries

1: USA
2: United Kingdom
3: Japan
4: France
5: Germany
6: Canada
7: Denmark
8: China
9: Italy
10: Spain
11: Israel
12: Korea
13: Sweden
14: Netherlands
15: Australia
16: Switzerland
17: Ireland
18: Poland
19: Saudi Arabia
20: Norway
21: Singapore
22: Taiwan
23: Hong Kong
24: Croatia
25: Turkey
26: Argentina
27: Austria
28: Belgium
29: Bangladesh
30: Brazil
31: Greece
32: Peru
33: Russia
34: Ukraine

About the PFS Foundation

Headquartered in Somerset N.J., the Post-Finasteride Syndrome Foundation was established in July 2012 as a 501(c)(3) organization, with private grants from families in the U.S. and abroad.  Tax-deductible financial donations to the nonprofit organization can be made via PFSFoundation.org, which also houses patient-recruitment information on active clinical studies, published research, research goals, and media reports about PFS.

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Contact

Philip Roberts
Post-Finasteride Syndrome Foundation
proberts@pfsfoundation.org
(856)425-6046

 

 

 

Reminder: Report PFS Symptoms to FDA MedWatch

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Reminder: Report PFS Symptoms to FDA MedWatch

Taking Action Can Lead to Safety Alerts,
Label Changes or Product Recalls

SOMERSET, N.J., Oct. 29, 2013 – The Post-Finasteride Syndrome Foundation is reminding PFS patients to report all persistent side effects to the FDA MedWatch program.

MedWatch is the U.S. Food and Drug Administration’s system for detecting safety-hazard signals for pharmaceutical products and medical devices. If a signal is detected, the FDA can issue safety alerts, or order product recalls, withdrawals or labeling changes to protect the public health.

Established in 1993, MedWatch collects reports of adverse reactions and quality problems, primarily with drugs. An adverse event is any undesirable experience associated with the use of a medical product, including persistent side effects.

PFS has been reported to occur in men who have taken the prescription drug finasteride to treat hair loss (under the brand name Propecia and generics), or enlarged prostates (Proscar and generics).

Reported symptoms include loss of libido, erectile dysfunction, suicidal ideation, anxiety, panic attacks, Peyronie’s disease, penile shrinkage, gynecomastia, muscle atrophy, cognitive impairment, severely dry skin, tinnitus, and depression. The condition often has a life-altering impact on victims and their families, such as job loss and the breakup of marriages and romantic relationships, while also being linked to suicides.

In April 2012, as a result, in part, of hundreds of PFS patients filing MedWatch reports, the FDA ordered drug manufacturer Merck to revise the labeling on Propecia to reflect mounting evidence that it can cause persistent sexual dysfunction.  Of the 421 Propecia-related sexual dysfunction cases reviewed by the FDA in its probe, 14 percent lasted longer than three months after patients quit the drug.

“It’s critical that the FDA be informed of each and every finasteride user who has experienced long-term side effects from the medication,” said PFS Foundation CEO Dr. John Santmann.  “If you haven’t already filed a MedWatch report, please do so as soon as possible.”

Voluntary reporting by patients and health care professionals is conducted via a one-page reporting form that can be accessed online at FDA.gov.

Reporting can also be conducted by phone at 800-FDA-1088, or by submitting FDA form 3500 via regular mail to: “MedWatch: The FDA Safety Information and Adverse Event Reporting Program, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20852-9787.”

PFS patients are also encouraged to report their persistent side effects to RxISK.org, a global, independent pharmacovigilance organization whose database is used by patients, doctors and pharmacists to research prescription drugs and their side effects, ideally to identify problems early on in the life of a drug.

About the PFS Foundation

Headquartered in Somerset N.J., the Post-Finasteride Syndrome Foundation was established in July 2012 as a 501(c)(3) organization, with private grants from families in the U.S. and abroad.  Tax-deductible financial donations to the nonprofit organization can be made via PFSFoundation.org, which also houses patient-recruitment information on active clinical studies, published research, research goals, and media reports about PFS.

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Contact

Media Relations Manager
The Post-Finasteride Syndrome Foundation
media@pfsfoundation.org
(856)425-6046

 

 

Clinical Study of Post-Finasteride Syndrome Launched at Baylor College of Medicine

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Clinical Study of Post-Finasteride Syndrome
Launched at Baylor College of Medicine

Research Aims to Determine Why Potentially Thousands of Men
Have Persistent Sexual Dysfunction After Quitting Finasteride

SOMERSET, N.J., Aug. 21, 2013 – The Post-Finasteride Syndrome Foundation today announced the funding of a second major clinical study on post-finasteride syndrome (PFS), this one at Baylor College of Medicine (BCM) in Houston, Texas.

Dr. Mohit Khera (above): Pioneering PFS research.

Dr. Mohit Khera (above): Pioneering PFS research.

Titled “Genetic and Epigenetic Studies on Post-Finasteride Syndrome Patients,” the research is being led by Mohit Khera, M.D., M.B.A., M.P.H., Assistant Professor of Urology in the Scott Department of Urology and Director of the Laboratory for Andrology Research, McNair Medical Institute at BCM.

The objective of the study is to determine why PFS patients develop sexual dysfunction.

PFS has been reported to occur in men who have taken the prescription drug finasteride to treat hair loss (under the brand name Propecia and generics), or enlarged prostates (Proscar and generics).

Reported symptoms include loss of libido, erectile dysfunction, suicidal ideation, anxiety, panic attacks, Peyronie’s disease, penile shrinkage, gynecomastia, muscle atrophy, cognitive impairment, severely dry skin, tinnitus, and depression. The condition often has a life-altering impact on victims and their families, such as job loss and the breakup of marriages and romantic relationships, while also being linked to suicides.

On July 1, the PFS Foundation announced the funding of its first clinical PFS study, at Brigham and Women’s Hospital (BWH) in Boston, a teaching affiliate of Harvard Medical School. That study aims to identify causes of the condition at the molecular level.

Details of the BCM study are as follow:

Principal Investigator: Mohit Khera, M.D.

Institution: Baylor College of Medicine; St. Luke’s Episcopal Hospital and The Methodist Hospital.

Title: Genetic and Epigenetic Studies on Post-Finasteride Syndrome Patients

Objective: To study why the patient population of post-finasteride syndrome (PFS) patients develops sexual dysfunction.

Methods: To (i) evaluate sexual and psychological function, (ii) assess hormone levels, (iii) measure penile hemodynamic and sensory parameters, (iv) study androgen receptor genetics and gene expression, and (v) and determine gene expression patterns and profiles.

Why This Study is Important

  • This study will evaluate parameters of peripheral sexual function in patients with PFS.
  • This study will uncover the underlying biological mechanisms related to the wide array of symptoms in PFS patients which closely match those of the androgen deprivation syndrome.
  • This systematic investigation will help identify the genetic footprint of PFS and the array of deregulated androgen dependent functions.
  • This study will elucidate the hormonal, genetic and epigenetic molecular mechanisms of the PFS.
  • This study will provide leads for the development of mechanism-specific therapeutic strategies.

Patient recruitment for the BCM study got under way in July/August 2013.

Patients interested in participating in the study should email Sharon A. Harrison, Administrative Coordinator for Dr. Khera: sharons@bcm.edu

“Coupled with the Brigham and Women’s Hospital study, the Baylor research promises to pave the way for PFS therapies by uncovering the root causes of this condition that is likely affecting thousands of men worldwide,” said PFS Foundation CEO Dr. John Santmann.

On April 11, 2012, the Food and Drug Administration ordered drug manufacturer Merck to revise the labeling on Propecia to reflect mounting evidence that it can cause persistent sexual dysfunction.  Of the 421 Propecia-related sexual dysfunction cases reviewed by the FDA in its probe, 14 percent lasted longer than three months after patients quit the drug.

About Dr. Mohit Khera

Specializing in andrology, sexual wellness and male reproductive medicine, Dr. Khera is Assistant Professor of Urology in the Scott Department of Urology and Director of the Laboratory for Andrology Research, McNair Medical Institute at the Baylor College of Medicine.  He also serves on the board of directors of the Sexual Medicine Society of North America (SMSNA) and the executive council of the American Society of Andrology (ASA), while serving as Associate Editor of the Journal of Sexual Medicine.  Dr. Khera earned his medical degree from The University of Texas Medical School at San Antonio. After finishing a six-year residency in urology at Baylor, he completed a one-year fellowship in male reproductive medicine and surgery with Dr. Larry I. Lipshultz. Dr. Khera edited the most recent edition of the book Urology and the Primary Care Practitioner, and in 2009 won the SMSNA Basic Science Award.

About Baylor College of Medicine

Baylor College of Medicine in Houston is recognized as a premier academic health science center and is known for excellence in education, research and patient care. It is the only private medical school in the greater southwest and is ranked as one of the top 20 medical schools for research in the country and number one in Texas by U.S. News & World Report. BCM is listed 17th among all U.S. medical schools for National Institutes of Health funding, and No. 2 in the nation in federal funding for research and development in the biological sciences at universities and colleges by the National Science Foundation. Located in the Texas Medical Center, BCM has affiliations with nine teaching hospitals. Currently, BCM trains more than 3,000 medical, graduate, nurse anesthesia, and physician assistant students, as well as residents and post-doctoral fellows. Follow BCM on Facebook and Twitter.

About the PFS Foundation

Headquartered in Somerset N.J., the Post-Finasteride Syndrome Foundation was established in July 2012 as a 501(c)(3) organization, with private grants from families in the U.S. and abroad.  Tax-deductible financial donations to the nonprofit organization can be made via PFSFoundation.org, which also houses published research, research goals, and media reports about PFS.

About Dr. John Santmann

Dr. Santmann brings three decades of medical experience to the PFS Foundation.  An Emergency Department physician by training, he spent two years in residency at Norfolk General Hospital in Norfolk, Va., after completing his internship at Alameda County Medical Center in Oakland, Calif.  From 1988 to 1999, he practiced at both community- and academic-based medical centers in Missouri and New Jersey, including the Robert Wood Johnson Medical Center in New Brunswick, N.J.  In recent years, Dr. Santmann has worked in the field of healthcare information technology.  He earned his M.D. from Washington University School of Medicine in St. Louis and his B.A., in biophysics, from The Johns Hopkins University.

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Contact

Media Relations Manager
The Post-Finasteride Syndrome Foundation
media@pfsfoundation.org
(856)425-6046

PFS Patient Query: Suicide Cases

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PFSF-logo-3

 

August 7, 2013

 

Dear Friends:

The PFS Foundation is seeking information about patients who have taken finasteride or dutasteride, and who have attempted suicide or who have completed suicide.

This is an area of active research interest and researchers are seeking to obtain medical records and other relevant material for such patients.

To reply to this query, please send the following information:

  • Name of patient
  • City/country of residence
  • If patient is deceased, (a) name of person replying to query, and (b) relation to deceased
  • Date of suicide
  • Or, date(s) of suicide attempt
  • Active email address and (optional) telephone number where you can be reached 

All information will be kept strictly confidential.

Please reply to: SuicideStudy@pfsfoundation.org

Thank you.

 

PFSF-address2

‘We Wouldn’t Recommend that Any Man Take’ Finasteride, Urologist at University Hospital Zurich Tells Swiss TV News Magazine

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‘We Wouldn’t Recommend that Any Man Take’ Finasteride, Urologist at University Hospital Zurich Tells Swiss TV News Magazine

 

May 20, 2018

Dear Friends:

Yet another European nation has taken to the airwaves with PFS awareness.

This time it’s Switzerland. The network is Swiss Radio and Television (SRF). And the program is Puls.

On May 7, the weekly health-news magazine debuted a special report titled Do Anti-Baldness Remedies Make You Impotent? (English-subtitled version here.)

The nine-minute program, hosted by Odette Frey, features an interview with Franz Fuchs, a 54-year-old PFS patient from Konzell, Germany, who took Propecia for 14 years, before quitting in 2001.

“Take this medication off the market so that there won’t be any more people as messed up as me,” says Franz. “Someone who doesn’t have this condition would find it hard to believe that such a medication can completely destroy a person’s life. I would give up all my hair if I could just be healthy again.”

Like Vice magazine editor Julian Morgans just two weeks earlier, we applaud Franz for having the courage to go public with his story. And, again, we look forward to the day when every PFS patient on earth feels comfortable doing the same.

Also cited in the Puls report are four Swiss dermatologists: Andreas Arnold, Christian Sigg, Thomas Kundig, and Ralph Trüeb, who’s among our volunteer team of health care professionals listed in the Patient Support section of the PFS Foundation website.

A Swiss urologist as well weighs in.

“We are certainly very cautious, because we see the side effects,” says Doris Mannhard of finasteride.“We wouldn’t recommend that any man take the drug, especially not young men. The longer they take it, the greater the risk of experiencing persistent side effects, including after they’ve stopped.”

This Puls report marks the fourth European nation to address PFS in a documentary or network-news feature format, after Spain, Belgium and France.

We remind all PFS patients who have not yet done so to report their symptoms to the FDA’s MedWatch program as directed here . Those living outside the US should also access the WHO’s Collaborating Centre for International Drug Monitoring list of pharmacovigilance agencies and report to their respective health agency.

Finally, if you or a loved one are suffering from PFS, and feeling depressed or unstable, please don’t hesitate to contact us as soon as possible via our Patient Support hotline: social@pfsfoundation.org

Thank you.

Common pathways between PFS and post-SSRI sexual dysfunction could be useful in designing therapeutic strategies for both, says new University of Milano study

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Common pathways between PFS and post-SSRI sexual dysfunction could be useful in designing therapeutic strategies for both, says new University of Milano study

 

April 30, 2018

Dear Friends:

Roberto Cosimo Melcangi, Ph.D., head of the Neuroendocrinology Unit in the Department of Pharmacological and Biomolecular Sciences at the University of Milano, has published a new paper in the current issue of Endocrine: International Journal of Basic and Clinical Endocrinology.

Titled Post-finasteride syndrome and post-SSRI sexual dysfunction: two sides of the same coin? the nine-page review “discusses the knowledge accumulated so far on the pathological phenotype of post-finasteride syndrome (PFS) and a post-SSRI sexual dysfunction (PSSD).”

“Sexual dysfunction is a feature shared by PFS and PSSD. This common aspect could be casual or rather be determined by common mechanisms that, once detected, could be useful to understand the pathophysiology and to possibly design therapeutic strategies for these conditions,” writes Prof. Melcangi, whose research team on this project includes Silvia Giatti, Silvia Diviccarom, and Giancarlo Panzica.

“In particular…neuroactive steroids, serotonin and dopamine are variably interconnected with PSSD and PFS… The finding that both PFS and PSSD, and consequently the persistent sexual dysfunction observed, occurred only in a limited number of patients may suggest possible epigenetic mechanisms,” he adds.

Please note that this review is separate from Prof. Melcangi’s current study, designed to examine epigenetic changes in PFS patients. For details on that research, which we announced in January, please access our Foundation News page.

If you’d like to help advance medical research on PFS, please visit our Donate page soon and give generously.

Thank you.

Leading German Paper Calls on Federal Institute for Drugs to Better Educate Doctors, Patients on PFS

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Leading German Paper Calls on Federal Institute for Drugs to Better Educate Doctors, Patients on PFS

 

March 12, 2018

Dear Friends:

PFS is a growing concern in Germany, too. Ditto Albania.

In December, we told you that the French National Agency for Drug Safety (ANSM) launched a public-awareness campaign warning against reported mood changes in Propecia patients, “particularly depression, and suicidal ideation.”

Now we’re encouraged to report that Die Zeit, Germany’s largest weekly newspaper, recently ran a 4,500-word feature on PFS, headlined I Didn’t Want to Go Bald. A Pill the Doctor Gave Me Destroyed My Life.

Written by investigative reporter Anne Kunze, the story focuses on Thorben Weber (not his real name), a German PFS patient whose life has been devastated by the condition.

“Back when Weber was still a cheerful young man, he would flirt often,” Kunze writes of the 33-year-old mathematics and music teacher. “In the teacher’s room, while playing sports on the weekends, while dancing at night; he usually found women who interested him… Now he no longer goes out in the evenings. He no longer trains at the gym… Now he lies on the sofa and watches series on Netflix.”

But Weber’s “real stunner,” Kunze continues, “reared its head in the form of so-called ‘brain fog’… It made him perceive colors as faded, and contrasts in his environment grew blurry… [He] suddenly started forgetting names of students he had taught for years… He no longer dared to go by car into the mountains, fearing he would not be able to find his way back.”

Within a year, “Weber was no longer able to shop for groceries or even to do his own cleaning, so he…moved back in with his parents. For weeks, he couldn’t go to work. One day he wrote down on a piece of paper that his younger sister should get his Audi A3 and his best friend his electric piano. Then he scouted a spot on the railroad embankment where…the trains go too fast to break.”

Fortunately, Weber mustered the will to live, and was eventually diagnosed with PFS by Dr. Michael Zitzmann, an andrology professor at the University of Munster, who is also among our volunteer team of health care professionals listed in the Patient Support section of the PFS Foundation website.

“Using finasteride for hair loss is like shooting at sparrows with cannons,” Zitzmann, who has examined approximately 100 PFS patients to date,” tells Die Zeit. “The drug…blocks not only the super hormone but also other hormones that affect thinking and psyche, mood and emotions. Discontinuation of the drug should actually make the hormones work again…but apparently, something breaks down in some men, in the prostate, in the brain, in the whole organism.”

Die Zeit also asserts that “the Federal Institute for Drugs and Medical Products should be the one to take action and request that doctors in Germany today better educate their patients. They did that when it came to thrombosis risks in new birth control pills. Doctors were sent checklists to pass onto their patients.”

Meanwhile Dr. Kim Drasa has been busy with a public-awareness campaign in his home nation of Albania.

The President of the Albanian Urologists & Sexologists Association, who’s also among our volunteer team of Patient Support health care professionals, recently penned an op-ed in Gazeta Panorama, one of Albania’s best-selling newspapers, and its highest-trafficked website.

Titled Adverse Side Effects from Medications Used to Treat Enlarged Prostate, the article recounts Dr. Drasa’s own negative experience with the 5α-reductase (5ARI) medication dutasteride.

“After being on the drug for just a week, I experienced severe ED. Moreover, I suffered from trembling, nerve twitches, anorexia, insomnia and other symptoms,” the urology professor writes. “So I immediately quit dutasteride. Within a week, I had stabilized—and never used it again. And I never again prescribed the drug to my patients who were sexually active.”

“In my own practice,” adds Dr. Drasa, “I have to date identified 137 5ARI patients who suffer from depression, self-harm and suicidal ideation, some of whom went on to attempt suicide. The Albanian National Agency for Drugs and Medical Devices needs to issue a drug-safety warning that finasteride and dutasteride can cause impotence and depression, as well as precipitate self-harm, suicidal behavior, and/or suicide.”

In France, meanwhile, we continue to see the impact of ANSM’s public-awareness campaign warning against depression and suicidal ideation.

Case in point: the current issue of La Revue Prescrire, a medical journal wholly independent of the pharmaceutical industry, features an article titled Finasteride: A growing risk of depression or suicidal ideation in hair-loss treatment.

“Suicidal ideation and depression are regularly reported in patients taking finasteride, including low doses for alopecia,” says the journal. “Given its low efficacy in treating alopecia, an exclusively aesthetic condition, the undesirable effects of finasteride are disproportionate: its balance of benefits versus risks is unfavorable in this situation.”

In a Periodic Safety Update last year, the European Medicines Association recommended that finasteride packaging be revised to include warnings of depression and suicidal ideation. In all, there are 31 member states that could potentially take such action, seven of which have done so to date: Belgium, Denmark, France, Germany, Netherlands, Poland and the United Kingdom.

English translations of Die Zeit and Gazeta Panorama stories can be accessed here:

Once again we’d like to remind all PFS patients who have not yet done so to report their symptoms to the FDA’s MedWatch program as directed here.

Those living outside the US should also access the WHO’s Collaborating Centre for International Drug Monitoring list of pharmacovigilance agencies and report to their respective health agency.

Finally, if you or a loved one are suffering from PFS, and feeling depressed or unstable, please don’t hesitate to contact us as soon as possible via our Patient Support hotline: social@pfsfoundation.org

Thank you.

Possible Epigenetic Changes in PFS Patients is Focus of New Clinical Study

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Possible Epigenetic Changes in PFS Patients is Focus of New Clinical Study at University of Milano

 

SOMERSET, N.J., Jan. 29, 2018 – The Post-Finasteride Syndrome Foundation today announced Phase II of the clinical research on post-finasteride syndrome (PFS) being conducted at the University of Milano.

Led by Roberto Cosimo Melcangi, Ph.D., head of the Neuroendocrinology Unit in the Department of Pharmacological and Biomolecular Sciences, the new study will evaluate:

—In PFS patients: possible epigenetic changes in the 5-alpha reductase enzyme.

—In an animal model of PFS: behavioral parameters, and alterations in neurogenesis, neuroinflammation and neurotransmitter pathways involved in the control of sexual function, as well as possible epigenetic changes in 5alpha-reductase. Possible changes of the gut microbiota composition will also be considered.

This research will build on the Neuroendocrinology Unit’s Phase I study, titled Neuroactive steroid levels and psychiatric and andrological features in post-finasteride patients, which was published in the July 2017 issue of The Journal of Steroid Biochemistry and Molecular Biology.

According to that research, PFS patients suffer from altered levels of critical brain-function regulators, including neuroactive steroids, and those with severe erectile dysfunction suffer from neuropathy of the pudendal nerve.

“Thanks to Professor Melcangi and his team, a clearer picture of what PFS looks like at the molecular level is slowly but surely emerging,” said Dr. John Santmann, CEO of the Post-Finasteride Syndrome Foundation, which funded the research.

Post-finasteride syndrome occurs in men who’ve taken finasteride to treat hair loss, or enlarged prostates. Reported symptoms include: loss of libido, erectile dysfunction, depression, suicidal ideation, anxiety, panic attacks, Peyronie’s disease, penile shrinkage, gynecomastia, muscle atrophy, cognitive impairment, insomnia, severely dry skin and tinnitus. The condition often has a life-altering impact on patients and their families, such as job loss and the breakup of marriages and romantic relationships, while also being linked to suicide.

The PFS Foundation has also funded clinical research and statistical analyses at other leading institutions, including:

Brigham and Women’s Hospital (Boston): Characteristics of Men Who Report Persistent Sexual Symptoms after Finasteride Use for Hair Loss, The Journal of Clinical Endocrinology & Metabolism, September 2016

Northwestern University Feinberg School of Medicine (Chicago): Persistent erectile dysfunction in men exposed to the 5α-reductase inhibitors finasteride or dutasteride, PeerJ, March 2017

Baylor College of Medicine (Houston): Genetic and Epigenetic Studies on Post-Finasteride Syndrome Patients

As of January 2108, the World Health Organization Programme for International Drug Monitoring’s database of adverse drug reactions contained 13,900 finasteride ADRs, including 2,477 reports of erectile dysfunction, and 2,956 psychiatric disorders including 32 suicide attempts, and 55 completed suicides.

In May 2017, the UK’s Medicines and Healthcare Products Regulatory Agency issued a drug-safety update titled Finasteride: rare reports of depression and suicidal thoughts. “Depression and suicidal thoughts,” it read, “have been reported in men with and without a previous history of depression.”

Three months later, the European Medicines Association issued a Periodic Safety Update, in which it noted, “Cumulatively 51 cases of suicidal ideation have been received… Taking into account the serious reported cases…[we] recommended to include a warning…to inform that mood alterations, depression and suicidal ideation have been reported with finasteride.” In all, there are 31 EMA member states that could potentially issue such warnings, seven of which have done so to date: Belgium, Denmark, France, Germany, Netherlands, Poland and the United Kingdom.

In March 2015, the U.S. National Institutes of Health listed PFS on its Genetic and Rare Diseases Information Center, noting that “some patients who have taken finasteride have referred to side effects such as sexual dysfunction and depression (sometimes severe)… Studies sponsored by the NIH and other organizations are underway to better understand the effects of 5-alpha reductase inhibitor drugs.”

About Roberto Melcangi

Prof. Melcangi received his Ph.D. degree in Chemistry and Pharmaceutical Technology from the University of Milano in 1982. He is currently Professor of Endocrinology and Head of the Neuroendocrinology Unit in the Department of Pharmacological and Biomolecular Sciences in the University of Milano, Italy, and serves on the editorial board of Frontiers in Aging Neuroscience. With 186 peer-reviewed publications (H-index = 46), he is a leading authority in the field of neuroendocrinology and neuroactive steroids, and is organizer of the International Meeting on Steroids and the Nervous System, held biannually in Turin, Italy.

About the PFS Foundation

Headquartered in Somerset N.J., the Post-Finasteride Syndrome Foundation was established in July 2012 as a 501(c)(3) organization, with private grants from families in the U.S. and abroad. Tax-deductible financial donations to the nonprofit organization can be made via PFSFoundation.org, which also houses patient-recruitment information on active clinical studies, published research, research goals, and media reports about PFS.  In July 2015, the PFS Foundation established The Southwest Brain Bank in the Department of Psychiatry at the University of Texas Health Science Center, whose mission is to collect and study post-mortem human brain and spinal cord tissue in patients with PFS in order to better understand the pathology and etiology of the condition.

#     #     #

Contact

Philip Roberts
Post-Finasteride Syndrome Foundation
proberts@pfsfoundation.org
(856)425-6046

French Warning of Propecia-Induced Depression and Suicidal Ideation Prompts Wave of Media Attention

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French Warning of Propecia-Induced Depression and Suicidal Ideation Prompts Wave of Media Attention

 

Dec. 19, 2017

Dear Friends:

France is taking PFS very seriously.

On Oct. 26, the French National Agency for Drug Safety (ANSM) issued a warning that “Changes in mood, particularly depression, and suicidal ideation, have been reported by patients taking Propecia.”

The agency—France’s equivalent of the US Food and Drug Administration—noted that “finasteride treatment should be discontinued in the presence of any psychiatric symptoms, and that “it is possible to observe persistent sexual disorders after stopping finasteride treatment.”

Two weeks later, ANSM’s director of dermatology, Dr. Caroline Semaille, launched a PFS public-awareness campaign, chiefly by relaying the potential dangers of finasteride to a number of national media outlets.

On Nov. 8, she told the France 2 news magazine 20 Heures “The addition to the [finasteride] insert is a clear warning to patients about the possible occurrence of these side effects, advising them to stop taking the drug and immediately consult their doctor.”

Dr. Semaille also told France 3 News, “Depressive disorders [stemming from finasteride] have not yet been formally established, but we have doubts and prefer therefore to inform the public.”

Dr. Semaille was equally vocal in the print media.

Daily newspaper Le Parisien ran a story headlined Propecia, Prescribed to 30,000 Men to Combat Hair Loss, Is on the Hot Seat. Doctors Issue Alert, which noted that:

“It was the publication of a study reassessing the risks of finasteride that pushed the [European Medicines Agency] to take more precaution. This Canadian survey of 93,000 men over the age of 66, published in May, showed an increased risk of depression in patients taking finasteride because of their prostate…

“ANSM has also looked closely at reports of adverse reactions to finasteride in France. There have been 40 such reports in nearly 20 years. And those numbers are not taken lightly.”

Le Parisien went on to quote Dr. Semaille as follows:

“We know [these adverse drug reactions] are undervalued, because France does not have much pharmacovigilance reflex. And, worldwide, 508 serious psychiatric cases, including 25 suicides, have been identified… From now on, you’re informed. So you decide.”

Weekly news magazine L’Obs published a story as well, headlined Prescription Hair-loss Medication Propecia Accused of Ruining Lives, in which Dr. Semaille said:

“No one forces patients to take finasteride. What’s important is that they be able to decide, that they be cognizant of what they may be risking if they take the drug.”

The four-page, 4,000-word L’Obs feature, which focuses on the 2016 suicide of 25-year-old PFS patient Romain Mathieu—and notes that “Nearly 128,000 Frenchmen were exposed to [finasteride] in 2016″—also cited PFS Foundation CEO Dr. John Santmann.

“When you take finasteride, you are eliminating the effects of testosterone. You don’t need to be a ranking scientist to figure out that finasteride is probably not a good idea,” Dr. Santmann said.

To watch English-subtitled versions of the 20 Heures and France 3 News stories, please access the PFS Foundation YouTube channel here.

English translations of the Le Parisien and L’Obs stories can be accessed here:

Le Parisien: Propecia, Prescribed to 30,000 Men to Combat Hair Loss, Is on the Hot Seat. Doctors Issue Alert

Le Parisien: Propecia Side Effects: Marc, 45, Plans to Complain

L’Obs: Prescription Hair-loss Medication Propecia Accused of Ruining Lives

(The original L’Obs story, in French, is here.)

Meanwhile, we’d like to remind all PFS patients, and/or their loved ones, who have not yet done so to report their symptoms to the FDA’s MedWatch program as directed here.

Those living outside the US should also access the WHO’s Collaborating Centre for International Drug Monitoring list of pharmacovigilance agencies and report to their respective nation’s health agency.

Finally, if you or a loved one are suffering from PFS, and feeling depressed or unstable, please don’t hesitate to contact us as soon as possible via our Patient Support hotline: social@pfsfoundation.org

Thank you.

European Medicines Agency Recommends Adding Depression and Suicidal Ideation to Finasteride Label

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Aug. 10, 2017

Dear Friends:

On August 4, CEO John Santmann wrote in his 2017 Annual Address, “Recent events in Europe and Asia have given me hope that, before this decade is out, we’ll see the day when no man on earth is prescribed finasteride without ample warning of its many potential dangers.”

Then he noted that both the UK’s Medicines and Healthcare Products Regulatory Agency and South Korea’s Ministry of Food and Drug Safety had recently mandated that finasteride packaging be revised to include warnings of depression and suicidal ideation.

Less than two days later, we got word that the European Medicines Agency (EMA), which oversees the scientific evaluation, supervision and safety monitoring of pharmaceutical products throughout the European Union, had followed suit.

In the agency’s most recent Periodic Safety Update, it writes:

Scientific Conclusions: The [Pharmacovigilance Risk Assessment Committee] noted that during the current interval two serious cases, one reporting suicidal behaviour and one reporting suicidal ideation, have been received for finasteride 5 mg. Cumulatively 51 cases of suicidal ideation have been received according to the information in the summary tabulation of adverse drug reactions from post-marketing sources.  Taking into account the serious reported cases…the PRAC recommended to include a warning…to inform that mood alterations, depression and suicidal ideation have been reported with finasteride. In addition, an advice to monitor patients and to remind them to seek medical advice should they develop psychiatric symptoms should also be included.

According to the EMA’s implementation timetable, the new warnings should be added by Member States and countries of the European Economic Area this month. In all, that’s 31 nations, from Austria to the United Kingdom, representing more than 500 million people.

Already, the French Ministry of Social Affairs and Health has revised its patient notice for Propecia to include this warning:

Changes in mood such as depressed mood, depression and, less frequently, suicidal thoughts have been reported in patients treated with Propecia. If you experience any of these symptoms, stop taking Propecia and contact your doctor as soon as possible for further medical advice.

Meanwhile, we’d like to remind all PFS patients who have not yet done so to report their symptoms to the FDA’s MedWatch program as directed here.

Those living outside the United States should also access the WHO’s Collaborating Centre for International Drug Monitoring list of pharmacovigilance agencies and report to their respective health agency.

Finally, if you or a loved one are suffering from PFS, and feeling depressed or unstable, please don’t hesitate to contact us as soon as possible via our Patient Support hotline: social@pfsfoundation.org

Thank you.

2017 PFS Foundation Annual Address

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2017 Annual Address

 

Aug. 4, 2017

 

Dear Friends:

Recent events in Europe and Asia have given me hope that, before this decade is out, we’ll see the day when no man on earth is prescribed finasteride without ample warning of its many potential dangers.

On May 24, the UK’s equivalent of the US Food and Drug Administration, the Medicines and Healthcare Products Regulatory Agency, issued a drug-safety update titled Finasteride: rare reports of depression and suicidal thoughts.

“Depression and suicidal thoughts have been reported in men with and without a previous history of depression,” it reads. “Depressed mood has been previously recognized with Propecia. A recent review of the evidence has suggested more significant depression can occur.”

On July 4, South Korea’s equivalent of the FDA, the Ministry of Food and Drug Safety, which received 1,351 adverse drug reaction reports for finasteride between 2013 and 2016, followed suit. The agency mandated that the label on Propecia and its generic versions warn against depression and suicidal ideation.

Now, to mark the PFS Foundation’s five-year anniversary, I’d like to share some additional highlights of the past 12 months.

MEDIA AWARENESS  

More and more, major media organizations are not just reporting on the existence of PFS, but exposing the devastating impact the condition often has on young men and their families.

In November, the maiden issue of Tonic, Vice Magazine’s health spinoff, ran a story headlined The Medical Mystery Behind America’s Best-Selling Hair-loss Drug. It begins:

When the shot rang out on Jan. 19, 2016, no one was around to hear it. Eric Carlos Rodriguez made sure. That day, the 33-year-old financial analyst…slipped on jeans and a hoodie, lifted a black Glock 9 mm handgun out of its case, and walked down the stairs to the pontoon boat docked outside his family’s vacation home. He’d been living with his parents in a nearby Los Angeles suburb for years, quietly battling a crushing brain fog and insomnia. As he’d recently confided to his mother Ana, he also suffered from a bizarre constellation of sexual symptoms that had shrunken and numbed his genitals…

In early January, he asked his parents if he could stay at their bayside villa in Oxnard for a while. They reluctantly obliged, texting often to check in. One day, he didn’t text back. His father found him on a Wednesday morning…a single shot to his temple. His parents aren’t sure when Eric pulled the trigger. But Ana is convinced she knows why. She says a rare side effect of the hair-loss drug finasteride, aka Propecia, killed her son.

That same month, French TV-news magazine Santé aired a story about a 25-year-old aspiring banker from Paris who endured PFS for more than three years.

On June 7, 2016, Romain Mathieu, who had several months earlier moved home from London where he’d been studying at the most prestigious business school in Europe—and had been scheduled to intern at Deutsche Bank in July—sealed himself in a tent at a local park. Then he released carbon monoxide gas which, as intended, ended his life.

He’d signed his suicide note “A victim of Propecia.”

“He was no longer himself. He was a ghost,” Romain’s mother Sylviane Mathieu told Santé. “I knew he’d be leaving us.”

Doctors as well are more frequently voicing their concerns about finasteride. Daniel Marchalik, a urologist at MedStar Washington Hospital Center, for instance, wrote a February 3 column in The Washington Post, in which he noted:

A recent study demonstrated changes in the levels of certain steroids in cerebrospinal fluid of men taking finasteride for hair loss. These steroids have been shown to influence brain function, and their presence may help explain the profound psychological changes such as depression and suicidality that have been associated with finasteride use. This research should cause us to think more carefully about this commonly encountered medication.

(For a complete listing of PFS news stories, please refer to our Media Awareness page.)

CLINICAL STUDIES

Three PFS Foundation-sponsored studies have appeared in major medical journals over the past nine months. In September, The Journal of Clinical Endocrinology & Metabolism published the study conducted at Brigham and Women’s Hospital and led by Shalender Bhasin, MD, a professor of medicine at Harvard Medical School.

Titled Characteristics of Men Who Report Persistent Sexual Symptoms after Finasteride Use for Hair Loss, the research suggested that men who experience persistent sexual dysfunction after discontinuing finasteride have “neurobiological abnormalities,” including neural circuitry that overlaps with functional abnormalities identified in men suffering from “major depression.”

Another key finding was that symptomatic finasteride users had “significantly lower IIEF [International Index of Erectile Function] composite score” and “significantly lower scores for each of its domains of erectile function, sexual desire, orgasmic function, intercourse satisfaction, and overall satisfaction.”

In March, PeerJ published the statistical analysis conducted at Northwestern University’s Feinberg School of Medicine by a team of nine researchers led by Assistant Professor of Dermatology Steven M. Belknap, MD.

Titled Persistent erectile dysfunction in men exposed to the 5α-reductase inhibitors finasteride or dutasteride, the study demonstrated that more than 1% of young men who took finasteride for 206 days or longer developed persistent erectile dysfunction (PED) that lasted an average of 4.2 years after drug discontinuation.

Among other key conclusions was that men 16 to 42 years old without prior sexual dysfunction exposed to finasteride ≤ 1.25 mg/day were more likely to have new ED and new low libido. Of these 4,284 men, 34 (0.8%) developed PED with a median duration of 1,534 days after drug discontinuation.

One month later, our second clinical study, conducted at the University of Milano’s Department of Pharmacological and Biomolecular Sciences by Roberto Cosimo Melcangi, PhD, appeared in The Journal of Steroid Biochemistry and Molecular Biology.

Titled Neuroactive Steroid Levels and Psychiatric and Andrological Features in Post-Finasteride Patients, the three-year project demonstrated that PFS patients suffer from altered levels of critical brain-function regulators, including neuroactive steroids.

In all, 16 men with PFS—all of whom had no prior history of erectile dysfunction or depression prior to finasteride use—and 25 control patients were evaluated by a team of 12 researchers, who also uncovered evidence of neuropathy of the pudendal nerve among those with severe ED.

Meanwhile, our clinical study at Baylor College of Medicine continues to progress steadily. The moment it’s published, we’ll announce the results.

SUPPORTING RESEARCH

In addition to the studies we’ve funded, we’ve seen a continued stream of research supporting the thesis that finasteride does in fact cause PFS.

Alessio Soggiu, PhD, an assistant professor at the University of Milano, published a paper in the October issue of Psyconeuroenocrinology titled Exploring the neural mechanisms of finasteride: A proteomic analysis in the nucleus accumbens. In it, he writes:

Recent evidence has shown that [finasteride], albeit generally well tolerated, can induce untoward psychological effects in a subset of patients… [Our research] showed that FIN treatment affected the expression of a number of accumbal proteins involved in key functional processes, such as regulation of GABAergic neurotransmission, as well as steroid and pyrimidine metabolism. These findings may prove crucial to understanding the neurochemical mechanisms of FIN’s neuropsychiatric side effects.

A month later, Sabina Cauci, PhD, an associate professor at the University of Udine’s Department of Medical and Biological Sciences, published a study in The Journal of Sexual Medicine titled Androgen Receptor (AR) Gene (CAG)n and (GGN)n Length Polymorphisms and Symptoms in Young Males With Long-Lasting Adverse Effects After Finasteride Use Against Androgenic Alopecia. She concluded that:

Short and/or long (CAG)n and (GGN)n repeats had different frequencies according to symptoms reported by patients with PFS, likely reflecting the vast array of genes modulated by the [androgen receptor]. This study showed a U-curvilinear profile of (CAG)n repeats for skin dryness symptoms, where the two extremes exhibited a worse condition than medium repeats. Further studies are necessary to investigate the PFS pathophysiology using a precision medicine approach.

(For a full directory of PFS-related studies, please visit our Published Research page.)

BRAIN BANK

In December, the Southwest Brain Bank, established a year earlier to study postmortem human brain and spinal cord tissue in patients with PFS, moved to Texas Tech University’s Health Sciences Center.  There, it’s housed in a new facility that affords Director Peter Thompson, MD, and his team greater resources and more robust technology for their ongoing research.

MEDICAL AWARENESS

We continue to expand our network of doctors and other health care professionals worldwide who have backgrounds in finasteride use and research, while educating them on PFS. Year over year, that network has grown from approximately 30,000 to 47,000.

And we continue to monitor and distribute the adverse drug-reaction reports for finasteride housed in the World Health Organization’s VigiBase database, so that medical professionals are aware of the rising global trends.

It’s disturbing to note that, according to those statistics, 45 men to date have taken their own lives due to finasteride ADRs, while another 31 have attempted suicide. In all, more than 13,600 finasteride ADRs have been filed with the WHO.

PATIENT SUPPORT

In last year’s address I announced a new section of our Resources page listing doctors who maintain an interest in helping PFS patients manage their symptoms. At the time, 20 had volunteered for inclusion. Today that list has more than doubled, to 51 medical professionals across 12 specialties in 17 nations.

From Irwin Goldstein in San Diego, Calif. to Keith Jarvi in Toronto, Canada to Olivier Chabre in Grenoble, France to Hoon Kang in Seoul, Korea to Kim M. Drasa in Tirana, Albania, we thank you one and all.

Meanwhile, our Patient Support program, designed to connect PFS patients with one another for moral support and sharing potentially helpful coping strategies, is shaping up to be one of our most popular resources.

In January 2016, Renato Wullschleger, a PFS patient from Frauenfeld, Switzerland, called to inform us that, after 15 years on Propecia, he began suffering from complete loss of libido, extreme muscle atrophy, incessant tinnitus, deep depression, and insomnia that “nearly robbed me of all my senses.”

At wits end, he jumped at the chance to speak to other PFS patients about how they managed to survive such health crises.

Eighteen months later, Renato phoned to let us know how much better he felt, thanks in part to the support of fellow PFS patients in Switzerland and the US, as well as to Roberto Melcangi, who provided a consultation via Skype.

“A psychiatrist put me on Seroquel for a few months after I crashed, which helped me get back to sleep,” he said. “But today I’m completely unmedicated. And while I still see my psychiatrist, he’s very satisfied with the progress I’ve made.”

“2016 was the worst year of my life,” he continued. “If not for all the encouragement and kindness I received from other men who’ve lived through similar nightmares, I’m not sure what I would have done.”

“My advice to any man suffering from PFS is to help yourself—move, go out, try to forget, be an optimist even when you’re in the depths of hell. And of course make music,” added Renato, whose rock band, The Circles, has been performing in Europe for more than 40 years.

As we embark on year six of our mission to fund research on and increase awareness of PFS, while helping support those afflicted by the condition, I ask you to continue giving generously to the PFS Foundation so that we may continue this vital work.

In the meantime, if you or a loved one are suffering from PFS, and feeling depressed or unstable, please don’t hesitate to contact us as soon as possible via our Patient Support hotline: social@pfsfoundation.org

Sincerely,

John Santmann, MD
CEO

Korea Mandates Propecia Label Change Based on Reports of Depression and Suicidal Ideation

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R E G U L A T O R Y   U P D A T E

South Korea Mandates Propecia Label Change Based on Reports of Depression and Suicidal Ideation

 

July 15, 2017

Dear Friends:

On July 4, the Korean Ministry of Food and Drug Safety (MFDS) announced it will revise the warning label on Propecia and its generic versions to include depression and suicidal ideation.

The move by South Korea’s equivalent of the US Food and Drug Administration came just six weeks after the UK’s FDA equivalent, the Medicines and Healthcare Products Regulatory Agency (MHRA), warned that finasteride has been linked to depression and suicidal ideation.

The MFDS action was prompted by a report from finasteride manufacturer MSD Korea Ltd., a subsidiary of Merck & Co., containing approximately 835 adverse drug reactions (ADRs) to finasteride, including erectile dysfunction, among Korean citizens.

MFDS records show that, from 2013 through 2016, the ministry received 1,351 finasteride ADRs within the Korean population, about 35 percent of which were reported by local medical facilities. (English translation here.)

In all, the revised warning will be added to 142 products, made by 98 pharmaceutical companies, all of which contain finasteride.

The revised label reads:

“Mood swings including gloomy mood, depression and suicidal thoughts were reported by patients taking 1mg of finasteride. Please be sure to observe patients for psychological symptoms. If any of the above symptoms occur, stop finasteride treatment and consult a medical provider.”

The agency’s action was widely reported throughout South Korea. According to the country’s largest news service, Yonhap News Agency:

“Propecia was released in the Korean market in 2000. When its patent expired in 2008, several generic drugs were also released in the market… Korean doctors tend to prescribe Monad (JW Shinyak) and Finated (Hanmi Pharm Co.) most among the generic versions of finasteride.”

Other news outlets carrying the story included:

  • MK Daily: The Food and Drug Administration announced on Tuesday that it has decided to add a warning on the label of Propecia, a drug for treating hair loss and prostatitis, that depression and suicidal thoughts may appear after administration.
  • YTN: Propecia, which is commonly used as a treatment for male hair loss, is expected to include warnings for depression and suicidal thoughts.
  • Shisa Journal: Use of Propecia for oral hair loss treatment will include a warning about depression and suicidal thoughts.
  • Social Responsibility Times: Propecia, which is commonly used as a treatment for male hair loss, is expected to include warnings of depression and suicidal thoughts.
  • Busan News: The Korea Food and Drug Administration has issued a warning that the use of finasteride-based hair loss treatment…may lead to depression and suicidal thoughts.
  • Korea Biomedical Review: The Ministry of Food and Drug Safety announced plans Tuesday to revise warning labels of 142 items, which include finasteride, commonly used in treatment for male hair loss, to indicate depressive and suicidal thoughts.

Additionally, Korea Biomedical Review ran a follow-up story headlined Korea one of the first countries to issue warnings on finasteride, which quoted the PFS Foundation on a number of key points:

“If you look at all the nations on earth, some 195 have yet to warn their citizens of the full risks posed by finasteride,” said Philip Roberts.

“Of the nearly 1,000 PFS patients we have spoken to around the world over the past five years, virtually every single one has said if he had been aware of all the potential side effects, he never would have taken it,” added Roberts.

To help ease the many burdens of PFS, the foundation last year launched a Patient Support Program that connects patients with fellow patients and their family members worldwide. As part of that program, we are able to connect family members of PFS patients who have taken their own lives with other family members dealing with the same tragedy.

Anyone interested in participating in these efforts, should download our Patient Support PDF or Suicide Support PDF, and email it back to social@pfsfoundation.org.

We’ve also been steadily building our list of doctors who see PFS patients and have volunteered to help counsel them on remaining stable. At present, there are 48 such medical professionals on that list, which can be found in the Patient Support section of our Resources page.

Meanwhile, we’d like to remind all PFS patients and/or their loved ones who have not yet done so to report their symptoms to the FDA’s MedWatch program as directed here.

Those living outside the United States should also access the WHO’s Collaborating Centre for International Drug Monitoring list of pharmacovigilance agencies and report to their respective health agency.

Thank you.

MHRA Issues Drug Safety Update on Finasteride

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MHRA Issues Drug Safety Update on Finasteride

 

UK surveillance agency cites reports of depression and suicidal ideation

 

May 26, 2017

Dear Friends:

The UK’s equivalent of the US Food and Drug Administration, the Medicines and Healthcare Products Regulatory Agency (MHRA), has issued a drug safety update on finasteride.

The May 24 document, titled Finasteride: rare reports of depression and suicidal thoughts, states:

Some men have reported episodes of depressive illness in association with the use of Propecia for male pattern hair loss. Some men also reported having suicidal thoughts.

Depression and suicidal thoughts have been reported in men with and without a previous history of depression. Depressed mood has been previously recognised with Propecia. A recent review of the evidence has suggested more significant depression can occur and so the advice is being updated to reflect this.

The product information for Proscar already lists depression as a possible adverse reaction and is being updated in light of a recent review.

The update also recommends that health care professionals “advise patients to stop finasteride 1 mg (Propecia) immediately if they develop depression.”

This action, and forthcoming label change, would not have occurred if the family members of several PFS patients who took their own lives had not brought those cases to the attention of the MHRA—and demanded that something be done.

For that, we thank them. And we encourage families of other PFS patients in nations across the globe to speak out with equal determination.

If you or a loved one suffer from persistent finasteride side effects, please report those side effects to the appropriate agency:

 

Thank you.

 

Peripheral Nervous System Involved in PFS Patients with Severe ED, New Study Demonstrates

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Peripheral Nervous System Involved in Post-Finasteride Syndrome Patients with Severe Erectile Dysfunction, New Study Demonstrates for the First Time

 

SOMERSET, N.J., April 18, 2017 – Post-finasteride syndrome (PFS) patients suffer from altered levels of critical brain-function regulators, including neuroactive steroids, according to a new clinical study published in The Journal of Steroid Biochemistry and Molecular Biology.

Titled Neuroactive Steroid Levels and Psychiatric and Andrological Features in Post-Finasteride Patients, the three-year study also uncovered evidence of neuropathy of the pudendal nerve among those with severe erectile dysfunction.

In all, 16 men with PFS and 25 control patients were evaluated in the study conducted at the University of Milano’s Department of Pharmacological and Biomolecular Sciences by a team of 12 researchers led by Roberto Cosimo Melcangi, Ph.D. The PFS patients had discontinued finasteride for a median of 5.4 years at the time of evaluation, and had no prior history of erectile dysfunction or depression prior to finasteride use.

Key findings of the study include broad effects on plasma and cerebrospinal fluid (CSF) neuroactive steroid levels observed in 14 PFS patients, as compared to 25 controls. Statistically significant decreased levels of DHT, pregnenolone, progesterone, 17-beta estradiol and dihydroprogesterone (DHP), and increased levels of DHEA, testosterone and 3-alpha diol were observed in the CSF of PFS patients.

In plasma, statistically significant decreased levels of DHP and allopregnanolone, and increased levels of pregnenolone, DHEA and testosterone were observed.

Decreased plasma levels of allopregnanolone and decreased CSF levels of progesterone are common features of anxious/depressive symptomatology.  Important physiologic effects of neuroactive steroids on brain function include neuroendocrine control of reproduction and sex behavior, synaptic plasticity, morphology of neurons and astrocytes, maintenance of cytoskeleton proteins and myelin, adult neurogenesis, and cognition-related functions.

The study also identified, in 25 percent of PFS patients, the first objective evidence of abnormal somatosensory evoked potentials (SSEP) of the pudendal nerve. Abnormal SSEP findings were observed in PFS patients with severe ED.

Peripheral neuropathy of the pudendal nerve, the major nerve supplying the genitals that is critical for peripheral neurogenic control of erection, in PFS patients is a novel finding that demonstrates for the first time involvement of the peripheral nervous system in PFS patients with severe ED.

Additionally, 50 percent of the PFS patients were diagnosed with major depression based on the results from validated questionnaires, the Mini-International Neuropsychiatric Interview, the Beck Depression Inventory and the Beck Anxiety Inventory.

Such depression represents the first confirmation of findings in research led by Shalendar Bhasin, MD and published last year in The Journal of Clinical Endocrinology & Metabolism (Characteristics of Men Who Report Persistent Sexual Symptoms after Finasteride Use for Hair Loss), which suggested that men who experience persistent sexual dysfunction after discontinuing finasteride have “neurobiological abnormalities.”

“Among the most important milestones of Professor Melcangi’s research is that it builds directly on Dr. Bhasin’s work,” said Dr. John Santmann, CEO of the Post-Finasteride Syndrome Foundation, which sponsored the study.

“Medical science is now one step closer to characterizing the underlying biologic mechanisms of PFS, which in turn promises to pave the way for the development of effective therapies,” he added.

The full JSBMB study is available here.

Post-finasteride syndrome occurs in men who’ve taken finasteride to treat hair loss, or enlarged prostates. Reported symptoms include: loss of libido, erectile dysfunction, depression, suicidal ideation, anxiety, panic attacks, Peyronie’s disease, penile shrinkage, gynecomastia, muscle atrophy, cognitive impairment, insomnia, severely dry skin and tinnitus. The condition often has a life-altering impact on victims and their families, such as job loss and the breakup of marriages and romantic relationships, while also being linked to suicides.

As of April 2107, the World Health Organization Programme for International Drug Monitoring’s database of adverse drug reactions contained 13,533 finasteride ADRs, including 2,694 reports of erectile dysfunction, and 3,109 psychiatric disorders including 44 completed suicides and 31 suicide attempts.

In March 2015, the U.S. National Institutes of Health listed PFS on its Genetic and Rare Diseases Information Center, noting that “some patients who have taken finasteride have referred to side effects such as sexual dysfunction and depression (sometimes severe)… Studies sponsored by the NIH and other organizations are underway to better understand the effects of 5-alpha reductase inhibitor drugs.”

About the PFS Foundation

Headquartered in Somerset N.J., the Post-Finasteride Syndrome Foundation was established in July 2012 as a 501(c)(3) organization, with private grants from families in the U.S. and abroad. Tax-deductible financial donations to the nonprofit organization can be made via PFSFoundation.org, which also houses patient-recruitment information on active clinical studies, published research, research goals, and media reports about PFS.  In July 2015, the PFS Foundation established The Southwest Brain Bank in the Department of Psychiatry at the University of Texas Health Science Center, whose mission is to collect and study postmortem human brain and spinal cord tissue in patients with PFS in order to better understand the pathology and etiology of the condition.

 

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Contact

Philip Roberts
Post-Finasteride Syndrome Foundation
proberts@pfsfoundation.org
(856)425-6046