- Recent reports suggest a link between use of the anti-baldness medication finasteride (Propecia) and the incidence of depression, including suicidal ideation and other negative health effects among users.
- Due to an investigation by Reuters, unsealed court documents and records reveal that U.S. regulators, as well as drug manufacturer Merck, were aware of reports of suicidal behavior among users of the drug.
- They failed to include information about these potential risks in a 2011 update of the drug’s warning label.
For many people, as they age, hair loss can be a pressing — at times upsetting — concern.
Androgenetic alopecia is the most common cause, which is experienced by more than 50 percent of people over age 50, according to the U.S. National Library of Medicine.
There are countless over-the-counter and prescription treatments for hair loss. Still, one popular anti-baldness drug, in particular, has generated controversy over recent reports that tie it to the incidence of depression — including suicidal ideation — and other negative health effects among users.
The headlines concerning these reports offer a reminder to those seeking anti-baldness treatments to consult their doctors about any new medication they might be considering.
The drug in question is finasteride, which is sold under the brand name Propecia.
Due to an investigation by Reuters, unsealed court documents and records reveal that U.S. regulators and drug manufacturer Merck were aware of reports of suicidal behavior among users of the drug.
They failed to include information of these potential risks in a 2011 update of the drug’s warning label.
Reuters revealed that since that call over whether that information be included on the warning label, the Food and Drug Administration (FDA) received more than 700 reports of suicidal thoughts and deaths by suicide among those using Propecia or its off-brand generic versions.
That number included at least 100 deaths. The news agency reports that within the first 14 years of Propecia sales, the FDA received 34 of these reports, which include those of 10 deaths.
They report that an internal company assessment shows that in 2009, Merck itself received 200 reports of depression — including suicidal ideation — among male users.
It was determined there wasn’t a high enough number of reports or enough specifics about cases of suicidal behavior and depression to require more than what was deemed regular monitoring of this data.
A studyTrusted Source published in 2020 showed that reports of anxiety, depression and suicidal thoughts among young men 45 or younger who used this drug increased significantly in the years since 2012.
That information was derived from a World Health Organization (WHO) database of drug safety reports from more than 150 nations, mirroring a 2015 study that looked at cases of sexual dysfunction and suicidal thoughts among people ages 18 to 45.
For its part, Merck said that “the scientific evidence does not support a causal link between Propecia and suicide or suicidal ideation and these terms should not be included in the labeling,” in a statement released to Reuters regarding the latest report.
“Merck works continuously with regulators to ensure that potential safety signals are carefully analyzed and, if appropriate, included in the label for Propecia,” the statement reads.
The FDA issued its own statement, asserting that it “continues to monitor postmarketing safety data for Propecia.”
The agency added that these kinds of reports do not “mean the drug caused the adverse event” and that related medical problems can be due to the “underlying disease being treated, caused by some other drug being taken concurrently, or occurred for other reasons.”HEALTHLINE EVENTThere is hope ahead
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Given Propecia, and other drugs like it are so commonly used, how concerned should you be if you’re seeking hair loss treatment?
“Patients should keep in mind that Propecia, or finasteride, is a very effective medication for most patients with male pattern hair loss, androgenetic alopecia, and that most people will feel better taking it because it is helping their hair loss,” said Dr. Carolyn Goh, associate clinical professor of dermatology at the David Geffen School of Medicine at UCLA.
Goh added that people pursuing this medication “should be aware of their mood while taking it” and look to “alternatives if they have a history of depression or other mental health problems.”
Dr. Barney Kenet, a New York City-based board-certified dermatologist, echoed those thoughts that if someone had a pre-existing mental illness, “it would be of concern that Propecia would unmask or exacerbate some mental health conditions symptoms.”
“There is also a low incidence of sexual side effects — low libido and erectile dysfunction — and for those reasons, it’s important that they have a good working relationship with their doctor,” Kenet told Healthline.
Despite the recent negative stories about the medication, a quick social media search finds direct-to-consumer companies such as Hims and Roman Health regularly touting the drug.
When asked whether she felt this is a drug that should be highlighted right now, Goh told Healthline that it should be made clear that it is “generally a safe and effective drug.”
“Direct-to-consumer companies have the benefit of making effective drugs more widely available, which is great, but perhaps discretion is advisable in this situation,” Goh added.
Kenet said that when you offer these medications to a wide audience through these kinds of channels, some customers who are at higher risk for negative side effects might not be getting all the information they need from a “glorified mail-order company.”
Both doctors said that, as with any medication, consult a doctor and medical team.
Research the medication and review with a doctor or medical team to discuss any underlying medical conditions to ensure appropriate treatment.
If you have a history of depression or other forms of mental illness, what are alternatives if the reports about Propecia are a concern?
Goh suggested topical minoxidil, an FDA-approved treatment for baldness.
Topical minoxidil is also FDA approved for this kind of baldness, while it might not be as effective as finasteride, she added.
“Low dose oral minoxidil can be prescribed and may be a reasonable alternative. Topical finasteride can also be specially compounded and prescribed,” Goh said.
She cited studies in a 2018 reviewTrusted Source that show there “may be some benefit and safety” in topical finasteride, but “the studies are not rigorous and there is no commercially available formulation of it to know if it would be consistently helpful.”
“The laser comb, band, or cap — low-level laser therapy — is another option but tends to work less effectively. Platelet-rich plasma therapy with or without microneedling are other options as well,” Goh added.
Kenet also cited low-dose systemic minoxidil, but he stressed that this needs to be under the direct care of a doctor.
“There are weaves, toupees, and hair transplantation that are non-pharmaceutical,” Kenet added.
Underlying this discussion of safety around Propecia is the impact hair loss can have on one’s mental health. It can be distressing and sudden.
It also must be stressed that it impacts both men and women.
Essentially, for all people, it can take a psychological toll, especially those with underlying mental health conditions.
Whether compounded by the medication a person takes or not, what can one do to manage stress tied to balding?
Kenet said that “baldness is a big part of our culture, from movie stars to athletes.”
He said that while there is less shame attached to it now and that it doesn’t bear the stigma it had in the past, “it still can be quite traumatizing.”
Kenet recommends support groups like the digital platform “Patients Like Me” as well as the “The Bald Truth,” a radio show that is all things hair loss.
Goh highly recommends seeking help from a mental health professional.
“Online forums can be very helpful and are easily accessible, but they may not be moderated, so should be approached with caution,” Goh explained. “Many people may be hesitant to discuss with family and friends, but they may be surprised by how many people have experienced similar situations, so could be a good source of support.”