Although finasteride came on the market in the 1990s, the science that led to its development 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 have long known about children who follow an … Read more
Highlights Estimated Propecia revenue from 1999–2015: $5.2 billion Rough estimate of operating profit from Propecia: $4.2 billion 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 … Read more
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.
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.
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
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
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
See also: The Merck files: a series In regulatory, internal and media communications in the 2000s, Merck responded to concerns about reports of adverse events associated with Propecia, including persistent erectile dysfunction and depression. These documents seek to discount the validity of these reports by way of the following points: “insufficient” information including lack of … Read more
It seems the 2012 statement from FDA — that these labeling changes are not new warnings — was incorrect.