Emerging evidence & commentary on risks of finasteride as a treatment for hair loss
This is an Appendix to the post: Polls vs. official data on side effect rates. Summary Mobile users: swipe left to see more columns. ID & source Date posted Participants % with side effects % with severe or persistent side effects P1. r/tressless Jan 2016 146 53.4% NA P2. r/HairLoss Jul 2021 110 27.3% NA … Read more
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.
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.
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 alters levels of chemical messengers in the blood as well as peripheral … Read more
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
Physician-researchers blamed growing safety concerns on patients, overlooking social context and weaknesses in safety regime The official view of Propecia, fashioned by Merck at a reported cost of $450 million, is that the drug is safe and effective. Upon approval by FDA in 1997, this view was carried forward by dermatologists, some of whom were … Read more
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.
Despite serious methodological shortcomings—including the preposterous use of on-drug safety data as a proxy for a post-drug condition—the authors nevertheless blame the post-drug syndrome on patient shortcomings. Zhang et al. have yoked bad logic to biased data in order to deflect attention away from drug harms.
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 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