Agencies in France, the United Kingdom, Canada and the United States are strengthening warnings about finasteride risks
In 2010, Merck requested to add a warning of depression to the Propecia label. A safety group within FDA concurred, but FDA’s dermatology products group did not support the change. Over a decade later, FDA required the addition of ‘suicidal ideation and behavior’ to the Propecia label.
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 subsequent documents, there is a back-and-forth between Merck and the Agency as to the validity of these reports and the overall safety concern. Merck used an arsenal of arguments to discount these reports and claim its own data is superior to postmarketing data.
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
In its Drugs@FDA database, FDA has at least nine versions of the Propecia label going back to 2001. This post will trace the history of changes to adverse effects in the label for consumers. A summary of label changes: 2001 – “Side effects went away in men who stopped taking Propecia” “A small number of … Read more