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