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 […]
Possible Epigenetic Changes in PFS Patients Is Focus of New Clinical Study
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 […]
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 […]
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: ‘Muscle-related Disorders’ Added to Canadian Finasteride Label in Response to Report by FDA-equivalent Agency
July 28, 2018 Dear Friends: Canada has taken an important first step toward keeping its citizens apprised of finasteride’s many potentially serious and persistent side effects. In the June edition of its Health Product InfoWatch, Health Canada (Canada’s version of the US Food and Drug Administration) reported that “New information regarding the risk of muscle-related […]
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 […]