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Regulatory Update: European Medicines Agency Recommends Adding Depression and Suicidal Ideation to Finasteride Label
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 […]
2017 PFS Foundation 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 […]
Regulatory Update: 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 […]
Regulatory Update: MHRA Issues Drug Safety Update on Finasteride
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 […]
Peripheral Nervous System Involved in PFS Patients with Severe ED, New Study Demonstrates
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 […]
Doctors & Researchers Speaking Out
Men under the age of 40 who use finasteride for alopecia are at risk for suicide if they develop persistent sexual adverse effects and insomnia.
An important pattern of symptoms was common among all cases who committed suicide in the setting of finasteride use: insomnia and persistent sexual dysfunction after medication discontinuation. Insomnia and fatigue/tiredness were some of the most debilitating symptoms… Men under 40 years of age who use finasteride for alopecia are at risk of suicide if they develop persistent sexual adverse effects and insomnia.
—Finasteride and Suicide: A Postmarketing Case Series: Dermatology, January 14, 2020
Two subjects—eight percent—committed suicide during or after the study.
While the sexual side effects of 5ARIs are well known, there may be persistent genitourinary, physical, psycho-cognitive, anti-androgenic and penile vascular changes after 5ARI discontinuation. Use of 5ARIs for treatment of AGA may lead to persistent sexual, genitourinary, physical, psycho-cognitive, and anti-androgenic sequelae even after cessation of 5ARI therapy… Two subjects (8%) committed suicide during or after the study.
—Penile vascular abnormalities in young men with persistent side effects after finasteride use for the treatment of androgenic alopecia: Translational Andrology and Urology, April 2020
Health care professionals should…conduct a full evaluation and a…risk-benefit assessment for patients before each prescription of finasteride.
As prescribers, our primary duty is to do no harm. Health care professionals should keep themselves abreast of these potential signals and, accordingly, conduct a full evaluation and a detailed, personalized risk-benefit assessment for patients before each prescription of finasteride.
—Ongoing Concerns Regarding Finasteride for the Treatment of Male-Pattern Androgenetic Alopecia: JAMA Dermatology, November 2020
This drug for young men must be taken off the market.
As of 2018, 15,000 cases of adverse reactions to finasteride were reported to the WHO—which is a huge number to begin with. And the interesting thing is that the average age of this group was 32 to 34 years old… This drug for young men must be taken off the market.
—Documentary on German network NDR titled Side Effects of Finasteride Are Underestimated: January 25, 2021