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Adverse Effects section - exposure and pregnancy
I wish to propose an addition to the Adverse Effects section. For the comment on contraindication in pregnancy I think it could be improved. The current text is:
Finasteride is contraindicated in pregnancy. The Food and Drug Administration advises that donation of blood or plasma be deferred for at least one month after taking the last dose of finasteride.
I suggest, based on Refs 36 and 37 (manufacturers' prescribing information as deposited with the FDA), that the above be altered to:
Finasteride is contraindicated for women who are pregnant or become pregnant while exposed to it, as it may cause abnormalities in a male fetus. Exposure through skin contact to broken or crushed tablets is identified as a risk vector. The Food and Drug Administration advises that donation of blood or plasma be deferred for at least one month after taking the last dose of finasteride.
The motivation for this proposed edit is to (i) specify the reason as to why finasteride is contraindicated (abnormalities in the male fetus may be caused) and (ii) to add a comment that skin contact is a risk vector. I think that the latter is important to include as this is important information for someone who may have come into contact with finasteride unwantedly due to the serious consequences.
Silverfoil92 (talk) 13:56, 31 March 2022 (UTC)
- I was amazed that this isn't mentioned in the article. I will something on this on a later date. Robert Brockway (talk) 03:24, 9 December 2023 (UTC)
Recent developments & sources
Editors may want to consider the following for the article.
1. Regulatory news
1.1. Boxed warnings were added to finasteride (1 mg) packaging per ANSM
France's national regulator ANSM required all manufacturers add a red boxed warning to all finasteride 1 mg boxes, on sexual and psychiatric adverse effects. Organon, the current marketing authorization holder, removed the drug from the market in France.
Source: Finastéride 1 mg (Propecia et génériques) : ajout de mentions d’alerte sur les boîtes pour renforcer l’information sur les effets indésirables. ANSM (France). November 30, 2022.
1.2. FDA required new disclosure of risk of suicidal ideation and behavior to finasteride (1 mg) label
Source: Levine, Dan. FDA requires disclosure of suicide risk for anti-baldness drug. Reuters. June 10, 2022.
1.3. Health Canada alerting doctors to risk of suicidal ideation and self-injury
Health Canada Safety Review, Jan 19 2023
From key points: “Health Canada's review of the available information found a possible link between the use of finasteride and the risks of suicidal ideation and self-injury..." The agency will update product information and inform healthcare professionals through a regulatory communication.
1.4. UK Medicines and Healthcare products Regulatory Agency (MHRA) launches a safety review of finasteride
Source: Ennals, Ethan. “Watchdog launches investigation into hair loss pill...” Daily Mail. March 4, 2023.
2. Medical literature
2.1. New review
Leliefeld HHJ, Debruyne FMJ & Reisman Y. The post-finasteride syndrome: possible etiological mechanisms and symptoms. Int J Impot Res. 2023. doi:10.1038/s41443-023-00759-5
A statement of limitations is relevant: "LIMITATIONS. Scientific literature on the PFS has the intrinsic limitation, by definition, that symptoms can persist or even appear after cessation of the 5ARIs and therefore have been unnoticed and not documented in the literature. The earlier mentioned lack of quality studies has hampered our knowledge of the presence, frequency and duration of the side effects...” Mariedegournay (talk) 23:44, 1 October 2023 (UTC)
2.2. Diagnostic criteria for post-finasteride syndrome
Healy D, Bahrick A, Bak M, et al. Diagnostic criteria for enduring sexual dysfunction after treatment with antidepressants, finasteride and isotretinoin. Int J Risk Saf Med. 2021. doi:10.3233/JRS-210023
Sourcing regarding post-drug disorder
I have seen bad-faith behavior by experienced wikipedia editors regarding editing of the post-finasteride syndrome section. Specifically, one of the editors inserted a low-quality source, and they seemed to be making arbitrary decisions about the quality of other sources depending on whether those sources supported their view. While I was not directly involved in a conflict, I stopped editing when I realized that the editing process was vulnerable to such abuse.
The source the editor featured is: Trüeb, et al (August 2019). "Post-Finasteride Syndrome: An Induced Delusional Disorder with the Potential of a Mass Psychogenic Illness?". Skin Appendage Disorders. doi.org/10.1159/000497362
It is a case report which does not contribute any systematic evidence. It makes a psychological claim, but the authors are dermatologists without apparent training in psychiatry. There was no formal psychiatric evaluation of the patient. The case summary is very subjective and judgmental (describing the patient as “humorless and oversensitive” — doesn't seem professional for the doctors to put this in an article). From this one case, which lacked a serious clinical investigation, the authors created an elaborate and bizarre theory. The wikipedia editor highlighted this article, but overlooked dozens of other articles on the syndrome with a wide range of views. This is the most extreme of the lot, and I do not see how it would meet sourcing standards, given how stringent editors often are about medical sourcing. (I wonder why this was an exception.)
Editors should understand that most of the clinical trial evidence base was sponsored by Merck. The remainder was mostly by dermatologists who do not pay close attention to drug harms—and do not usually have expertise psychiatry or sexual medicine. Some literature that casts doubt on the syndrome from 2014–2020 was authored by physician-scientists who were contracted with Merck to promote Propecia or co-published articles with its researchers. For example, Dr. Antonella Tosti, Dr. Jerry Shapiro, Dr. Kevin McVary and Dr. Steven Kaplan. (By the way, Tosti is co-Editor-in-Chief at Skin Appendage Disorders where the above article by Dr. Trüeb appeared.)
Misplaced Pages is an encyclopedia, not a medical review organization, so I understand it cannot adjudicate on something like this. Nevertheless, editors should understand that this is an iatrogenic disorder (caused by medical treatment). There is a commercial bias built into the medical literature because so much of the evidence base came from Merck-sponsored studies. Meanwhile, as Leliefeld et al pointed out (see previous topic), there is a lack of research on post-drug harms. There is no money for such studies. Drug-related harms are threatening to medicine, so physicians may tend to deny and avoid these conditions. Again, Misplaced Pages can't adjudicate, but it seems a good encyclopedia should account for these circumstances, even when a source meets its criteria. An analogy here would be myalgic encephalomyelitis, denied for decades as malingering or depression, or Long COVID. Just because there are medical authorities or sources which cast doubt on a disease, that does not mean the disease is invalid.
Experienced wikipedians can be paranoid about ulterior motives of other editors, but they should also understand that conflicts of interest are rampant in medical “research” on pharmaceuticals. Mariedegournay (talk) 00:25, 2 October 2023 (UTC)
Additional context for post-finasteride syndrome
Different specialties have different positions on this syndrome.
Finasteride was first developed for prostate conditions, to be prescribed by urologists (approved in 1992). Then it was approved for hair loss, to be prescribed by dermatologists (approved in 1997). Certain urologists and dermatologists worked directly with Merck as “key opinion leaders” on each effort. Some of these same people have authored articles casting doubt on post-finasteride syndrome.
The specialty that has begun to recognize the syndrome is sexual medicine (a subspecialty of urology): see Leliefeld et al, 2023 and Healy et al, 2022. Recent dermatology articles either omit or downplay the syndrome.
Dermatology has conflicts of interest since they are prescribers, and Merck worked closely with this specialty to bring it to market. It's also relevant that dermatologists don't typically have special training in sexual medicine or neuropsychiatry. As a result, they are not in a position to recognize the syndrome. Mariedegournay (talk) 01:01, 2 October 2023 (UTC)
- Ah, the "scientists have a conflict of interest with science (when I don't like what they say)" gambit. For Misplaced Pages's guidelines on reliable sourcing for biomedicine, see WP:MEDRS. Bon courage (talk) 06:18, 2 October 2023 (UTC)
- From WP:MEDRS: "Case reports and series are especially avoided, as they are uncontrolled."
- See my discussion of the Trüeb article above. Mariedegournay (talk) 13:50, 2 October 2023 (UTC)
- The only "motives" being called into question are those of "experienced wikipedia editors ", "dermatologists" and Merck (by you). Pointing out a line of argument is flawed is necessary to make progress, I certainly agree we don't base WP:BMI on case reports. Bon courage (talk) 14:00, 2 October 2023 (UTC)
Long-Term Section - Flaws in studies cited
In the study "Sexual dysfunction in men taking systemic dermatologic medication: A systematic review" that is cited in the Long Term section of the Finasteride Wiki. Only level 1 evidence of Finasteride potentially causing long-term side effects is cited. This is very weak evidence and it far from being a double-blinded control study. In addition, there are no double blinded control studies currently that prove that Finasteride causes long-term side effects after the drug has stopped circulating in the blood.
In fact, in a double blind long-term control study there was no evidence of side-effect continuation after cessation of the drug: https://www.jaad.org/article/S0190-9622(98)70007-6/abstract
"These adverse events (Sexual dysfunction) also resolved in many of the patients who reported them but who remained on the finasteride regimen and continued in the study."
" a few men in the current studies experienced reversible impairment of sexual function, but only 11 men receiving finasteride, compared with 8 men in the placebo group, discontinued treatment for this reason, with resolution in all."
In conclusion, I feel that the evidence cited here is extremely flimsy and is contradicted by studies with better methodology, study design and far more subjects. Thus this entry should be removed as there is far stronger evidence to the contrary of what this study and entry claims. Zpalmati (talk) 19:48, 16 June 2024 (UTC)
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