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

Feinberg School of Medicine Epidemiology Study Suggests Tens of Thousands of PFS Cases in Young Men Taking Finasteride for Hair Loss

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Feinberg School of Medicine Epidemiology Study Suggests Tens of Thousands of Cases of Post-Finasteride Syndrome in Young Men Taking Finasteride for Hair Loss

 

  • 1.19% of men 16 to 42 years old with no prior history of sexual dysfunction taking low-dose finasteride for more than 205 days developed persistent erectile dysfunction (ED) lasting ≥ 90 days after discontinuation of therapy (PED)

  • The risk of PED in these young men increased over time with longer duration of finasteride therapy

  • One-third of young men with onset of new ED while taking low dose finasteride eventually developed PED

 

SOMERSET, N.J., March 9, 2017 – More than one percent 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, according to a new study published today in PeerJ.

In all, researchers examined the electronic medical records (EMR) of 4,284 men ages 16 to 42 with no prior history of sexual dysfunction who were exposed to ≤ 1.25 mg per day of finasteride, the dose commonly used to treat hair loss.

Titled Persistent erectile dysfunction in men exposed to the 5α-reductase inhibitors finasteride or dutasteride, the study was conducted at Northwestern University’s Feinberg School of Medicine by a team of nine researchers led by Steven M. Belknap, MD, Assistant Professor of Dermatology.

Key conclusions of the study, which was conducted using a repository of EMRs for 691,268 men ages 16 to 89 years from 1992 to 2013, are as follows:

  • Men 16 to 42 years old without prior sexual dysfunction exposed to finasteride ≤ 1.25 mg/day were more likely to have new ED (p < 0.0001) and new low libido (p < 0.0001). Of these 4,284 men, 34 (0.8%) developed PED with a median duration of 1,534 days after drug discontinuation.
  • Of the 103 young men with new ED, 34 (33%) developed new PED. Not included in this statistic were young men with new persistent ED who continued to take finasteride. PED developed in 1.19% of men with > 205 days of finasteride exposure.
  • The multivariable model predicting new PED in young men had one variable: duration of finasteride exposure. Young men with > 205 days of finasteride exposure had a 4.9-fold higher risk of PED (p < 0.004) than men with shorter exposure. The magnitude of risk of PED associated with longer duration of finasteride exposure was greater than all other risk factors and was independent of age.
  • The finding of a consistent effect provides evidence of an intrinsic relationship between duration of finasteride or dutasteride exposure for any clinical indication and PED.

“This study is the first to establish the extent of finasteride’s negative impact on sexual health based on a large critical mass of medical records,” said Dr. John Santmann, CEO of the PFS Foundation, which funded the study together with grants provided by the National Institutes of Health.

“The statistical results from this study should come as a wake-up call to dermatologists, internists and other MDs who regularly prescribe the drug. More than one out of every 100 men who take finasteride long term for hair loss will suffer devastating, long-term, and possibly permanent damage to their sexual health,” he added.

Please download the full study here.

Post-finasteride syndrome occurs in men who’ve taken finasteride to treat hair loss, or enlarged prostate glands. 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.

In June 2015, Dr. Belknap published a related study in JAMA Dermatology titled Adverse Event Reporting in Clinical Trials of Finasteride for Androgenic Alopecia.  According to that meta-analysis:

“Of 34 [finasteride] clinical trials, none had adequate safety reporting, 19 were partially adequate, 12 were inadequate, and 3 reported no adverse events… Available toxicity information from clinical trials of finasteride in men with [androgenic alopecia] is very limited, is of poor quality, and seems to be systematically biased… Published reports of clinical trials provide insufficient information to establish the safety profile for finasteride in the treatment of AGA.”

As of March 2, 2017, the World Health Organization Programme for International Drug Monitorings database of adverse drug reactions contained 13,554 finasteride ADRs, including 2,694 reports of erectile dysfunction, and 3,109 psychiatric disorders including 43 completed suicides and 32 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.

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

‘Underlying Neurobiological Abnormalities’ Exist in Finasteride Users with Persistent Sexual Dysfunction

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‘Underlying Neurobiological Abnormalities’ Exist in Finasteride Users with Persistent Sexual Dysfunction, Suggests Clinical Study at Brigham and Women’s Hospital

 

SOMERSET, N.J., Sept. 29, 2016 – Men who experience persistent sexual dysfunction after discontinuing finasteride have “neurobiological abnormalities,” suggests a new study published in The Journal of Clinical Endocrinology & Metabolism.

Among those abnormalities is neural circuitry that overlaps with functional abnormalities identified in men suffering from “major depression.”

Titled Characteristics of Men Who Report Persistent Sexual Symptoms after Finasteride Use for Hair Loss, the study was conducted at Brigham and Women’s Hospital in Boston by a team of 19 clinical researchers led by Shalender Bhasin, MD, a professor of medicine at Harvard Medical School.

Harvard Medical School’s Shalendar Bhasin led landmark PFS study.

Key findings of the investigator-initiated study, which included two separate fMRI activation tasks, one targeting affective dysfunction and one focusing on sexual arousal, are as follows:

  • 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.”
  • “The PHQ-9 depression scores were significantly higher” in symptomatic finasteride users.  Beck Depression Inventory and Hamilton Depression Inventory “also revealed significantly higher depression scores” in symptomatic finasteride users.
  • “As sexual function worsened (ie, as IIEF scores went down), there was increasing activity in the neural circuits corresponding to sexual arousal and decreasing activity in brain regions associated with higher level cognitive and motivational networks in symptomatic finasteride users in response to erotic stimuli.  This dissociation in activity may be a marker of neural changes post finasteride use.”
  • There exists “a significant positive correlation between a subset of BDI [Beck Depression Inventory] scores related to negative attitude and BOLD [blood oxygen level dependent] activity in the right nucleus accumbens, left pregenual anterior cingulate cortex, right insula, right lateral orbito-frontal cortex, and left posterior cingulate, as well as a negative correlation between BDI subscores and BOLD activity in the right parahippocampal/fusiform gyrus.  This neural circuitry overlaps with functional abnormalities that have been identified in major depression.”

“This research has several firsts, including use of the latest functional MRI imaging to identify areas of the brain affected by post-finasteride syndrome,” said Dr. John Santmann, CEO of the PFS Foundation, which funded the study along with Harvard Clinical Translational Research Institute and the Center for Clinical Investigation at the Brigham and Women’s Hospital.

“It’s a landmark study that not only takes a significant step toward validating the condition on a biological level, but lays the groundwork for future studies that promise to yield effective therapies,” he added.

Please download the full study 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 Sept. 26, the World Health Organization Programme for International Drug Monitoring’s database of adverse drug reactions contained 13,546 finasteride ADRs, including 3,577 sexual function and fertility disorders, 1,526 depressed mood disorders and disturbances, and 67 completed suicides.

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

Support Program Connects PFS Patients Worldwide

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Support Program Connects PFS Patients Worldwide

SOMERSET, N.J., Sept. 9, 2016 – The Post-Finasteride Syndrome Foundation has launched a program to connect PFS patients with one another for mutual support.

Any PFS patient or family member of a PFS patient who would like to participate should download the PFS Patient Support form, complete it and email it back to PFS Patient Support Program social@pfsfoundation.org.

Due to the urgency of many such requests, the foundation strives to respond to each one within two days.

“One of the tragic hallmarks of PFS is that patients’ health care providers and/or loved ones often don’t believe the condition exists. And even when they do become aware, they have no idea how to help,” said PFS Foundation CEO Dr. John Santmann.

“Over the past year, however, we’ve informally connected hundreds of PFS patients around the globe, most all of whom have let us know how beneficial it’s been to share coping strategies, nutritional tips, exercise regimens and so on,” added Dr. Santmann.

The foundation can also 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 should download the PFS Suicide Support form, complete it and email it back to social@pfsfoundation.org.

Post-finatesteride syndrome (PFS) 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.

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

2016 PFS Foundation Annual Address

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Aug. 4, 2016

 

Dear Friends:

I began last year’s annual address by letting you know how encouraged I was that the National Institutes of Health had not only added PFS to its Genetic and Rare Diseases Information Center but linked to our website.

Now I’m equally encouraged to note a similar milestone, achieved exactly one year later, halfway around the globe.

In March, New Zealand added a PFS page to its MedSafe directory, complete with sexual, physical, mental and neurological symptoms.

 

And a link to our website.

 

That was the first known instance of a foreign ministry of health officially acknowledging the condition.  But I hope it won’t be the last; I hope that before the decade is out, nations on every continent follow suit.

 

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

PATIENT SUPPORT: Due to an increasing number of inquires from PFS patients around the globe seeking medical advice, we added a Patient Support section to our Resources page.  Listed there are doctors who are aware of PFS and, in some cases, see patients who are believed to have the condition. While none of them professes to know the root cause(s) of PFS, nor claims to have a cure for the condition, they maintain an interest in helping PFS patients manage symptoms as best as possible until clinical research, hopefully, leads to the development of effective therapies. 

To date, 20 doctors across nine specialties – from urologist Seth D. Cohen (right) at New York University’s Langone Medical Center to psychiatrist Luis Guilherme Streb in Porto Allegre, Brazil, to cosmetic surgeon Ilhan Serdaroglu in Istanbul, Turkey – have volunteered to assist in this effort.
Concurrently, we launched a program to connect PFS patients who live in the same geographic area with one another.  This has proven successful in quickly enabling those who are in the early stages of PFS – and reach out to us, often desperate for help – to speak with those who are in the later, more stable stages.  In some cases, such patients live close enough to meet in person, for added moral support.  (If you or someone you know would like to participate in this program, please email social@pfsfoundation.org)

 

MEDICAL AWARENESS: We’ve continued to expand our list 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 list has grown from 2,500 to more than 30,000, focusing on staffers at leading hospitals, medical schools and medical journals, as well as national ministries of health. And in January, we began tracking 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.

MEDIA AWARENESS: Earlier this year, two documentaries on PFS debuted in Europe, one the Spanish public network TV3 (right), and another on the Belgian public network VRT, marking the first time the condition has been the subject of extended TV coverage.

We’ve also seen additional print-media coverage of the issue, both domestically and abroad. In September, the Australian-based International Business Times ran a story titled Post-Finaseride Syndrome Foundation funds 3 clinical studies on permanent side effects of prostate cancer, alopecia drug. Two months later, Men’s Journal, a leading US consumer publication, published a special report titled New Risks in Hair-Loss Drugs: The side effects of the most common male-pattern baldness pill—depression, insomnia erectile dysfunction—may be worse than we thought.  And potentially permanent.

SOCIAL MEDIA: We enhanced our social media presence last month by redesigning our Twitter, Facebook and YouTube pages, along with our logo (left). If you’d like to help us spread awareness of PFS, please visit us on these platforms and like, follow, share and/or subscribe as you see fit.

SUPPORTING RESEARCH: Peripheral to the studies we’ve sponsored, there has been a steady stream of research supporting the thesis that finasteride does in fact cause PFS. Abdulmaged M. Traish, PhD, professor of biochemistry and urology at Boston University School of Medicine, published a paper in the December issue of Current Sexual Health Reports titled The Impact of the 5α-Reductase Inhibitors (5α-RIs) on Male Sexual Function and Psychological Well-Being. In it he writes, “5α-Reductase inhibitors such as finasteride…have serious and, in some patients, persistent or irreversible sexual side effects. These agents interfere with the biosynthesis and metabolism of neurosteroids and may adversely affect mood, stress, and anxiety and potentiate the onset of depression.”

A month later, Carlo Trombetta, MD (right) at the University of Trieste’s Urological Hospital published a paper in Andrology titled An observational retrospective evaluation of 79 young men with long-term adverse effects after use of finasteride against androgenetic alopecia, in which he notes, “Concern regarding adverse effects of finasteride is increasing… The most frequent sexual symptoms referred were loss of penis sensitivity (87.3%), decreased ejaculatory force (82.3%), and low penile temperature (78.5%)…Further studies are necessary to investigate the pathophysiological and biochemical pathways leading to the post-finasteride syndrome.”

 

And in February, Christine A. Ganzer, PhD, assistant professor at City University of New York, published a paper in the American Journal of Men’s Health titled Emotional Consequences of Finasteride: Fool’s Gold. Ganzer writes: “Users of finasteride…report serious physical and emotional adverse effects, collectively known as post-finasteride syndrome… Results provide evidence on the need to screen for psychiatric history and counseling patients about the potential psychological consequences of finasteride. Prescribing clinicians should carefully weigh the risk/benefit ratio with these patients.”

 

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

 

CLINICAL STUDIES: Our clinical studies at Brigham and Women’s Hospital, Baylor College of Medicine and University of Milano continue to progress steadily. The moment each is published, we will let you know.

 

As we begin year five 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 foundation so that we may continue this vital work. And help prevent any more needless deaths in the coming year.

 

Sincerely,

John Santmann, MD
CEO

Two European Documentaries a Milestone in PFS Awareness

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European Documentaries a Major Milestone in
Post-Finasteride Syndrome Awareness

 

SOMERSET, N.J., July 14, 2016 – A pair of European documentaries focusing on post-finasteride syndrome mark the first time the condition has been the subject of extended TV coverage on any continent.

The first documentary, titled “Pills in Search of an Illness,” debuted April 19 on the Spanish public TV network TV3 in Barcelona.TV3-promo

Reported by veteran investigative journalists Montse Armengou Martín and Richard Belis, the 75-minute program features a chapter on the dangers of finasteride, including patient interviews in Spain and the U.S.

The second, “The Wonderhair Pill,” debuted May 19 on the Belgian public TV network VRT in Brussels. In the 20-minute special, investigative journalists Michael Dilissen and Sofie Coucke go under cover to show how local pharmacists fill prescriptions for finasteride without any package insert whatsoever, or verbal explanation, despite the fact that the latter is mandatory.

English-language versions of both documentaries were made available for the first time this week.

Post-finasteride syndrome (PFS) 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.

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 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)425-6946

 

Finasteride-Induced Suicides up 8.4% in WHO’s VigiBase

by
Finasteride-Induced Suicides Rise 8.4% in
WHO Database of Adverse Drug Reactions

 

SOMERSET, N.J., July 13, 2016 – Reports of finasteride-induced completed suicides are up 8.4% in the World Health Organization Progamme for International Drug Monitoring’s database of adverse drug reactions (ADRs) for Q1 through Q2 2016 over Q4 2015.

The absolute number of completed suicides rose from 59 to 64 within that period.  Also in the category of Suicidal and Self-Injurious Behavior, finasteride-induced suicidal ideation rose 4.2%, while suicide attempts rose 3.7%.

Overall, finasteride ADRs rose 2.7%, from 12,983 to 13,344 cases, during the same period. After completed suicides, the higest percentage increases are testicular and epididymal disorders (+7.5%), and penile and scrotal disorders (+7.5%).

Post-finatesteride syndrome (PFS) 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.

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.”

“The fact that five people have reportedly taken their own lives in the past six months as a result of adverse reactions to finasteride is horrifying,” said PFS Foundation CEO Dr. John Santmann. “Any patient being prescribed this medication should be clearly informed that among the risks are suicidal ideation and suicide.”

The PFS Foundation reminds PFS patients to report all persistent side effects to their respective national pharmacovigilance authorities for inclusion in the VigiBase database for adverse drug reactions (ADRs).

Run by Uppsala Monitoring Centre (UMC), which provides scientific leadership and operational support to the WHO, VigiBase reports of suspected ADRs are available to public-health officials and medical professionals in an effort to “contribute to a global culture of patient safety and well-being,” with further investigation of unknown or not well described ADRs being “of paramount importance.”

In April of 2015, VigiBase, the largest and most comprehensive pharmacovigilance database in the world, was opened to the public for the first time via its VigiAccess program.

PFS patients, their family members and/or health care providers should file ADR reports to the appropriate public-health official in their respective country.  (All reports will remain confidential in that patient names are never disclosed to the public.)

To download the list of officials in the 146 nations currently participating in the VigiBase program, click here.

Following is an overview of finasteride ADRs filed with UMC as of July 1, 2016.  All percentage increases represent Q1 2016 through Q2 2016 over Q4 2015 data. (To access the complete statistics, search “finasteride” in the VigiAccess database.)

Total finasteride ADRs filed (1993 – July 1, 2016)

  • 13,344 (+2.7%)

Finasteride ADRs by age range

  • 18 – 44 years: 2452 (+2.5%)
  • 45 – 64 years: 2042 (+2%)
  • 65 – 74 years: 1974 (+2.5%)
  • ≥ 75 years: 1488 (+2.8%)

Finasteride ADRs by gender

  • Male: 12,347 (+2.7%)
  • Female: 460 (3.6%)

Finasteride ADRs by type

  • Reproductive system and breast disorders: 5016 (+2.6%)
  • General disorders and administration site conditions: 3519 (0.6%)
  • Psychiatric disorders: 3192 (3.6%)
  • Nervous system disorders: 2771 (+3%)
  • Skin and subcutaneous tissue disorders: 2344 (+2.9%)
  • Investigations: 1791 (+3.2%)
  • Gastrointestinal disorders: 1564 (+4.4%)
  • Injury, poisoning and procedural complications: 1500 (+3.5%)
  • Musculoskeletal and connective tissue disorders: 1165 (+2.5%)

Finasteride ADR type by subcategory

Reproductive system and breast disorders

  • Sexual function and fertility disorders: 3530 (+2.8%)
  • Breast disorders: 1398 (+2.2%)
  • Testicular and epididymal disorders: 643 (+7.5%)
  • Penile and scrotal disorders: 597 (+7.5%)

Psychiatric disorders

  • Sexual dysfunctions, disturbances and gender identity disorders: 2153 (+4.3%)
  • Depressed mood disorders and disturbances: 1505 (3.7%)
  • Anxiety disorders and symptoms: 1375 (+3.2%)
  • Sleep disorders and disturbances: 544 (+4%)
  • Mood disorders and disturbances NEC: 490 (+3.6%)
  • Suicidal and self-injurious behaviors NEC: 280 (5.2%)

Suicidal and self-injurious behavior

  • Suicidal ideation: 195 (4.2%)
  • Suicide attempt: 28 (3.7%)
  • Completed suicide: 64 (8.4%)

About Uppsala Monitoring Centre

Based in Uppsala, Sweden, Uppsala Monitoring Centre evolved from the World Health Organization’s efforts to monitor drug safety in the wake of the thalidomide disaster of the 1960s, which caused more than 10,000 children to be born with Roberts syndrome (malformation of the facial bones and limbs), only 40 percent of whom survived. UMC is an independent foundation that supports international awareness and scientific research in the realm of pharmacovigilance, focusing on patient safety and the safe and effective use of medicines worldwide.

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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Related News

 

Contact

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

Finasteride-Induced Suicidal and Self-Injurious Behavior Rises 33% in WHO Database of Adverse Drug Reactions

by

Finasteride-Induced Suicidal and Self-Injurious Behavior Rises 33% in WHO Database of Adverse Drug Reactions

SOMERSET, N.J., Jan. 5, 2016 – Reports of finasteride-induced Suicidal and Self-Injurious Behavior are up 33 percent in the World Health Organization Progamme for International Drug Monitoring’s database of adverse drug reactions (ADRs) for Q4 vs. Q3 2015.

Within that category (itself a subcategory of Psychiatric Disorders), suicidal ideaton is up 47.2%; suicide attempts up 28.5%; and completed suicides up 7.2%, rising from 55 cases to 59.

Overall, finasteride ADRs rose 5.1%, from 12,350 to 12,983 cases, during the same period. Among the double-digit increases are: penile and scrotal disorders (+21.1%), sexual dysfunctions, disturbances and gender identity disorders (+13.5%), and sexual function and fertility disorders (+10.2%).

PFS 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.

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.”

“The fact that finasteride use has reportedly led to an average of one suicide a month over the past four months is highly distressing,” said PFS Foundation CEO Dr. John Santmann. “Health care professionals the world over need to be aware that a drug frequenly prescribed for cosmetic purposes could have the most dire impact imaginable.”

The PFS Foundation reminds PFS patients to report all persistent side effects to their respective national pharmacovigilance authorities for inclusion in the VigiBase database for ADRs.

Run by Uppsala Monitoring Centre (UMC), which provides scientific leadership and operational support to the WHO, VigiBase reports of suspected ADRs are available to public-health officials and medical professionals in an effort to “contribute to a global culture of patient safety and well-being,” with further investigation of unknown or not well described ADRs being “of paramount importance.”

In April of 2015, VigiBase, the largest and most comprehensive pharmacovigilance database in the world, was opened to the public for the first time via its VigiAccess program.

PFS patients, their family members and/or health care providers should file ADR reports to the appropriate public-health official in their respective country. (All reports will remain confidential in that patient names are never disclosed to the public.)

To download the list of officials in the 146 nations currently participating in the VigiBase program, click here.

Following is an overview of finasteride ADRs filed with UMC as of Jan. 1, 2016. All percentage increases represent Q4 2015 over Q3 2015 data. (To access the complete statistics, search “finasteride” in the VigiAccess database.)

Total finasteride ADRs filed (1993-2015)

  • 12,983 (+5.1%)

Finasteride ADRs by age range

  • 18 – 44 years: 2392 (+2.3%)
  • 45 – 64 years: 2001 (+3.7%)
  • 65 – 74 years: 1926 (+2.9%)
  • ≥ 75 years: 1447 (+3%)

Finasteride ADRs by gender

  • Male: 12,020 (+5.3%)
  • Female: 444 (+3.4%)

Finasteride ADRs by type

  • Reproductive system and breast disorders: 4886 (+7.6%)
  • General disorders and administration site conditions: 3497 (+8.1%)
  • Psychiatric disorders: 3079 (+10.8%)
  • Nervous system disorders: 2689 (+10.4%)
  • Skin and subcutaneous tissue disorders: 2276 (+7.5%)
  • Investigations: 1734 (+16.1%)
  • Gastrointestinal disorders: 1498 (+12.8%)
  • Injury, poisoning and procedural complications: 1449 (+20.1%)
  • Musculoskeletal and connective tissue disorders: 1136 (+18.9%)

Finasteride ADR type by subcategory

Reproductive system and breast disorders

  • Sexual function and fertility disorders: 3434 (+10.2%)
  • Breast disorders: 1367 (+5.7%)
  • Testicular and epididymal disorders: 598 (+19.3%)
  • Penile and scrotal disorders: 555 (+21.1%)

Psychiatric disorders

  • Sexual dysfunctions, disturbances and gender identity disorders: 2064 (+13.5%)
  • Depressed mood disorders and disturbances: 1451 (+16.6%)
  • Anxiety disorders and symptoms: 1332 (+17.1%)
  • Sleep disorders and disturbances: 523 (+22.7%)
  • Mood disorders and disturbances NEC: 473 (+21.2%)
  • Suicidal and self-injurious behaviors NEC: 266 (+33%)

Suicidal and self-injurious behavior

  • Suicidal ideation: 187 (+47.2%)
  • Suicide attempt: 27 (+28.5%)
  • Completed suicide: 59 (+7.2%)

 

About Uppsala Monitoring Centre

Based in Uppsala, Sweden, Uppsala Monitoring Centre evolved from the World Health Organization’s efforts to monitor drug safety in the wake of the thalidomide disaster of the 1960s, which caused more than 10,000 children to be born with Roberts syndrome (malformation of the facial bones and limbs), only 40 percent of whom survived. UMC is an independent foundation that supports international awareness and scientific research in the realm of pharmacovigilance, focusing on patient safety and the safe and effective use of medicines worldwide.

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.

#     #     #

Contact

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