Many pharmaceutical drugs come with an ominous list of risks, but the devil is in the details. How likely and dangerous are the side effects, and how do those hazards compare with whatever treatment the drug is meant to provide?
According to a new study, questions like those may not have received enough attention for one particular drug over the past two decades – and a similar lack of scrutiny may still be exposing patients to excessive dangers from other pharmaceuticals.
The new study focuses on finasteride, a prescription drug taken by millions of men since the 1990s. It’s commonly used to treat male pattern hair loss as well as benign prostatic hyperplasia, or non-cancerous enlargement of the prostate.
Related: Protein That Calms Waking Hair Follicles Could Lead to Alopecia Treatment
For years, however, there have been hints of finasteride’s effects on mood, writes study author Mayer Brezis, a retired nephrologist and medical professor at the Hadassah-Hebrew University Medical Center in Israel.
Despite mounting evidence linking the drug with serious psychiatric side effects – including anxiety, depression, and suicide – the manufacturers and the medical and regulatory communities have overlooked these findings to the detriment of public health, Brezis concludes.
The literature review encompasses eight studies published between 2017 and 2023 and incorporates data from multiple countries and data systems.
Its findings suggest people who take finasteride face a significantly higher risk of mood disorders and suicidal thoughts than those who don’t take it.
“The evidence is no longer anecdotal,” Brezis says. “We now see consistent patterns across diverse populations. And the consequences may have been tragic.”
The US Food and Drug Administration (FDA) listed depression as a potential side effect of finasteride in 2011, and added suicidality in 2022, although researchers had raised concerns as early as 2002.
In a trial related to the suicide of one finasteride user, Brezis reports, internal FDA documents revealed the agency’s experts had recommended adding “suicidal thoughts and behavior” to the warning label in 2010.
“The advice was rejected by the agency without disclosing the internal discussion and the rationale for the final decision,” Brezis writes. He cites sections of FDA documents that were concealed as confidential, including estimates of the number of people that might be affected.
“Transparency is crucial when facing inherent conflicts between innovation and safety, progress and public health,” Brezis writes.
The FDA had recorded only 18 suicides associated with finasteride by 2011, yet based on global usage of the drug, the new study suggests the total could be in the thousands. Rather than mere underreporting, Brezis attributes this to “a systemic failure of pharmacovigilance.”
According to Brezis, this includes failures by the drug’s original manufacturer, Merck, to conduct simple safety research using database analyses, as well as regulators neglecting to request such research from the manufacturer or to conduct it themselves.
In 2021, Merck told Reuters: “The scientific evidence does not support a causal link between Propecia [a brand name for finasteride] and suicide or suicidal ideation and these terms should not be included in the labeling.”
“Merck works continuously with regulators to ensure that potential safety signals are carefully analyzed and, if appropriate, included in the label for Propecia,” they said.
None of the studies in the latest review had been initiated by Merck or by regulators, with a lack of regulatory scrutiny potentially due in part to the drug’s classification as cosmetic.
Finasteride’s efficacy against hair loss arises from its interference with the conversion of testosterone into dihydrotestosterone (DHT), although the drug also inhibits the production of certain neurosteroids, such as allopregnanolone, linked to mood regulation.
In research on non-human animals, finasteride has been associated with long-term effects on brain inflammation and structural changes in the hippocampus, a brain structure involved with learning, memory, and emotion.
Even if patients stop taking the drug, psychiatric side effects could continue for months or years in a condition known as “post-finasteride syndrome.”
Experts have repeatedly explained how financial interests can override concerns over drug safety, which is what Brezis suspects happened with finasteride.
This apparent failure of pharmacovigilance falls on regulators as well as manufacturers, and the study outlines some takeaways for all parties.
Brezis concludes that medications like finasteride should not be approved unless researchers can clearly establish their safety. Even after a drug like this is approved, he adds, ongoing safety research should be legally required to ensure the approval is warranted.
“The lesson is that before approving a medication for the market, regulators should require manufacturers to commit to performing and disclosing ongoing post-approval analytical studies, and this requirement needs to be enforced,” Brezis writes.
The study was published in the Journal of Clinical Psychiatry.
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