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France’s No. 1 News Magazine Takes Federal Drug Agency to Task for Letting PFS Proliferate
July 31, 2018 Dear Friends: Thirty-thousand Frenchman can’t all be immune to PFS. And the nation’s most widely read news magazine seems bent on proving it. In a July 21 feature story headlined Finasteride, the Controversial Drug that Medical Authorities Continue to Defend (English translation here), investigative reporters Camélia Echchihab and Emre Sari write: “Can […]
Regulatory Update: Germany’s FDA Equivalent Issues ‘Red Hand Letter’ on Finasteride ADRs
July 6, 2018 Dear Friends: Apparently heeding an appeal by Germany’s largest weekly newspaper, the Federal Institute for Drugs and Medical Devices (BfArM) has dispatched a so-called Red Hand Letter to doctors and pharmacists nationwide, informing them of severe and persistent adverse drug reactions (ADRs) to finasteride. Five months ago, we told you that Die […]
‘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.) […]
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 […]
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 […]
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 the age of 40 who use finasteride for alopecia are at risk for suicide if they develop persistent sexual adverse effects and insomnia.
—Finasteride and Suicide: A Postmarketing Case Series: Dermatology, January 14, 2020
[A]t least 17 countries…have warned…of the potential for depression, sexual side effects, or both.
Emerging post-marketing reports of persistent depression and sexual side effects have led to growing concerns about the safety of 5α-reductase inhibitors and prompted product labeling changes in many regulatory jurisdictions. Since 2008, at least 17 countries including the United Kingdom and the United States have warned prescribers of the potential for depression, sexual side effects, or both with finasteride.
—Post-Finasteride Syndrome: Efforts to explain persistent symptoms are undermined by poor long term data on harms: The BMJ, August 9, 2019
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
FDA is concerned that use of finasteride by pediatric patients may pose long-term safety risks.
Finasteride inhibits Type II 5(alpha)-reductase, which metabolizes testosterone to the potent androgen 5(alpha)-dihydrotestosterone. FDA is concerned that use of finasteride by pediatric patients may pose long-term safety risks regarding growth, development and sexual function.