How Merck buried finasteride’s full impact on chemical signaling
Merck told a simplified story of finasteride’s mechanism. In fact, the drug’s action predicts widespread disruptions of complex pathways which are critical for behavior and reproduction. Merck’s own research had shown this. Real world experience with finasteride confirms the connection: impairments in finasteride users affect systems regulated by these same pathways.
A rundown of new bibliographies & research guides
The research base spans many disciplines and goes back almost 50 years. To help researchers get oriented, an on-ramp was added. In the Systems & functions area, a new bibliography was added: Adverse effects on skin, comprising nine case reports. The gynecomastia bibliography has been expanded. The bibliography on the musculoskeletal system has been expanded … Read more
2022 – year in review
Regulators added warnings, the New York Post covered finasteride harms, and two influencers urged followers to avoid the drug.
In June 2022, the FDA required the addition of ‘suicidal ideation and behavior’ to the Propecia (finasteride 1 mg) label. In July, France’s national drug regulator ANSM added materials to help patients better understand the risks of finasteride.
Hair or manhood—choose one?
In ancient Greece, Hippocrates and Aristotle observed that eunuchs did not go bald. Jumping ahead to the early 1940s, American anatomist James B. Hamilton reviewed histories of men with testosterone deficiency and found a pattern: the earlier the age of hormone deficiency, the less balding occurred.
Musculoskeletal adverse events of finasteride
When men take finasteride for hair loss, their attention is directed to the hair and scalp. When adverse events (AEs) occur in other systems and areas of the body, it might not be obvious that finasteride could be the culprit. But the drug serves to lower dihydrotestosterone in the blood as well as peripheral tissue … Read more
Disability and deaths in men who used finasteride
Databases of drug adverse events contain tremendous variation. They include reports from patients of all ages, and many took other drugs that might explain outcomes. In this analysis, cases were limited to men ages 18–40 where the ‘Suspected Product’ field only contained finasteride (or, in the comparison below, minoxidil). This is only a fraction of … Read more
FDA quashed internal warning on suicidality linked to Propecia; changed course in 2022
KEY POINTS In 2010, Merck requested to add ‘depression’ to adverse events in the Propecia label. A safety group within FDA concurred, and also recommended adding ‘suicidal thoughts and behavior.’ FDA’s dermatology products group did not support adding a suicidality warning. Only ‘depression’ was added to the label in 2011. Over a decade later, in … Read more
Context matters: a rebuttal to yet another analysis of adverse events of finasteride
This post responds to a recent research letter: Disproportional signal of sexual dysfunction reports associated with finasteride use in young men with androgenetic alopecia: a pharmacovigilance analysis of VigiBase.
A tweeted rebuttal to yet another analysis of finasteride adverse events
A thread originally posted on Twitter is reproduced below. For an in-depth version, see the essay Context matters. See also a critique of three previous papers with similar designs, findings and conclusions. Twitter thread Nguyen et al, 2022 is the fourth analysis of adverse events of finasteride to appear since 2018. All four studies play … Read more
How was finasteride invented?
Although finasteride came on the market in the 1990s, the underlying research began two decades earlier. The rationale for the drug emerged from a study of a unique group of people in a remote village in the Dominican Republic called Las Salinas. Locals there have long known about children who follow an unusual developmental path: … Read more
Merck’s Propecia business
HIGHLIGHTS Merck received FDA approval for Propecia (finasteride 1 mg/day) in December 1997. Sales in the first year of marketing were reported to be $76 million. The peak years were 2010–2011, when Merck reported $447 million in Propecia sales in each year. In total, Merck booked an estimated $5.2 billion in sales of Propecia. We … Read more
Since 1994, Merck has been aware of unresolved sexual dysfunction in men who stopped taking finasteride
Six months after discontinuing a Phase 3 finasteride trial, a man’s sexual adverse experience was unresolved. There were also 16 men whose drug-related sexual adverse experiences were unresolved at the conclusion of the trial.
The Merck files, part 3: Propecia lawsuits
Filings from lawsuits alleging persistent adverse effects of Propecia and Proscar in various jurisdictions in the United States and Canada, dating from 2011 to 2021.
The Merck files, part 2: Merck responds to regulatory concerns about persistent adverse effects of Propecia
These documents from 2006–2009 concern Merck’s response to postmarketing reports of persistent erectile dysfunction, male infertility and depressive disorders, among other adverse events, associated with use of finasteride. In 2006, the Swedish Medical Products Agency asked Merck for an analysis of all adverse events affecting the male reproductive system which persisted after stopping Propecia. In … Read more
The Merck files, part 1: An inside look at the development of Propecia
Merck first developed finasteride for benign prostatic hyperplasia, a condition typically found in men aged 55 and older. After receiving approval for the application in 1992 and bringing the drug to market as Proscar, Merck decided to seek approval of finasteride for male pattern hair loss—to be branded as Propecia. In a 1994 memo below, … Read more
The Merck files: a series
Selected documents from Propecia litigation were released by court order in 2021. This series walks through these documents, revealing Merck’s strategy for discounting safety concerns arising from clinical trials and adverse event reports. The collection is divided into three parts: 1. An inside look at the development of Propecia (1994–2001) 2. Merck responds to regulatory … Read more
When medical treatment brings on disease: iatrogenic disorders
Those who have lasting dysfunctions after taking finasteride or dutasteride are not the only ones whose lives have been altered for the worse because of a medical treatment. This post summarizes diseases and conditions that may arise from medical treatments in dermatology, psychiatry, surgery and general medicine. ↓ Jump to the list Every treatment has … Read more
This site describes adverse experiences which some may find disturbing. See the Reader advisory.
Places to start
- Thinking about taking finasteride for hair loss? See Weighing the risks.
- This post compiles research on changes in penile tissue and function associated with finasteride and dutasteride treatment.
- For a historical perspective, see the timeline which starts with a study in Dominican Republic in the early 1970s.
- The research bibliography gathers hundreds of papers on adverse effects of finasteride and other 5-alpha reductase inhibitors. See also Research by system & function.
5-AR deficiency Adverse effects Adverse event reports Animal studies Anxiety Bias Bibliography Clinical trials Conflict of interest Denial and skepticism Dermatologists Dermatology Doctor views Documents Drug label Dutasteride Etiopathology Europe FDA Firsthand reports FOIA requests Hair transplant surgeons History Litigation Merck Merck files News Penile abnormalities Persistent adverse effects Pharmacology Pharmacovigilance Polls Post-finasteride syndrome Propecia Psychological adverse effects Recoveries Research Sexual adverse effects Sexual dysfunction Shame and stigma Social context Social media SSRIs Steroid biosynthesis Vigibase