Pharmacovigilance

Polls vs. official data on side effect rates

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Since online polls are anonymous, there is less risk to disclosing embarrassing side effects. In online polls, the rate of side effects was 6.2x greater than the rate of adverse events in a clinical trial. The clinical setting may suppress safety concerns in sensitive areas such as sexuality and mental state.

Appendix: Results of online polls on side effects

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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

Musculoskeletal adverse events of finasteride

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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

Disability and deaths in men who used finasteride

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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

From the depths: why finasteride harms took decades to emerge

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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

A tweeted rebuttal to yet another analysis of finasteride adverse events

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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

Merck communications regarding reports of persistent erectile dysfunction and depression associated with finasteride

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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

Responding to a literature of doubt: limitations of three studies of adverse events of finasteride and dutasteride

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A fourth study has been published in the ‘literature of doubt’. Read the rebuttal. Background on the co-author of Baas et al, 2018 with a disclosed conflict of interest is here. Three studies analyzing adverse event (AE) data related to finasteride and dutasteride were published from 2018–2020 (the “AE papers”).1–3 The first to appear, by Baas … Read more

Adverse events affecting reproductive anatomy & sexual function in men ages 18–40

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This post documents adverse events (AEs) of finasteride affecting male reproductive anatomy and sexual function in men age 18–40, reported to US FDA from 2000 to 2020. See the Methodology section for more details. Category Adverse events(2000–2020) Erectile dysfunction & sexual dysfunction 1,021 Penile abnormalities 494 Testicular abnormalities 301 Semen and sperm abnormalities 259 Ejaculatory … Read more