Q: What do I do if I start experiencing side effects on finasteride? — L.L. ~ Riverdale, N.Y.
A: Don’t panic, just stop the medication and let your doctor know. He or she will give you guidance based on your symptoms.
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Recent news reports, coupled with warnings from Merck and the FDA, about Propecia’s possible persistent sexual side effects have caused growing concern about this popular hair loss treatment. An increasing number of men now fear that Propecia (finasteride 1mg) will cause permanent sexual dysfunction.
Merck’s and the FDA’s warning, however, was based on a small number of random self-reports, not on empirical studies that showed a cause and effect relationship between finasteride and sexual dysfunction. There are two possible reasons that existing studies have not found a significant relationship between finasteride use and persistent sexual dysfunction: 1) the effect of finasteride on sexual function is too small to significantly measure in any one study, or 2) finasteride has no significant negative effect on sexual function.
To address the first possibility, Aditya K Gupta and Andrew Charrette ((Gupta AK, Charrette A. The efficacy and safety of 5α-reductase inhibitors in androgenetic alopecia: a network meta-analysis and benefit-risk assessment of finasteride and dutasteride. J Dermatolog Treat. 2014;25(2):156-61.)) at the University of Toronto recently conducted a large scale meta-analysis across 16 controlled studies, studies designed to test the efficacy of finasteride, to see if a significant number of patients in those studies reported persistent sexual side effects. The rationale of a meta-analysis is that if there is an effect (of finasteride on sexual function) that is too small to measure in any one particular study, then it may be possible to detect the effect if one pools data from many different studies.
Gupta and Charrette analyzed the results of 16 studies that compared various doses of finasteride against a placebo and found that finasteride consistently proved effective in stopping or slowing hair loss. They also found that the number of self-reported cases of persistent sexual dysfunction by patients given finasteride was statistically no different from the number reported by patients given a placebo.
In other words, they found that finasteride was no more likely to cause persistent sexual dysfunction than a placebo.
This study supports the conclusion of existing literature that there is no correlation between finasteride use and persistent or permanent sexual dysfunction. That said, this is an important issue that still needs to be studied.
Posted byQ: I’ve heard that FDA added a description of reports of male infertility to the side effect labels of both Propecia and Proscar (finasteride). Is this a likely side effect in your experience? — S.S., Rolling Hills, California
A: Propecia (finasteride 1mg) may lead to male infertility not only by changing the consistency of the male ejaculate but by decreasing the sperm count as well, but this is uncommon.
Ejaculate is a combination of sperm produced by the testes and a viscous fluid made by the prostate. Since finasteride shrinks the prostate, it can make the ejaculate less viscous (more watery).
Most patients trying to conceive will have no issues while taking Propecia.
If one is having difficulty trying to conceive for 4-6 months, then it is reasonable to stop taking Propecia.
It is important to know that taking Propecia while trying to conceive will not lead to congenital deformities or issues with the fetus as long as the woman does not come in direct contact with the medication.
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The 21st Annual Scientific Meeting of the International Society of Hair Restoration Surgery was held in San Francisco from October 13 through 26, 2013. The meeting covers the most important scientific and clinical advances in the field of surgical hair restoration.
As a member of the panel on “Difficult Cases,” that explored challenging and atypical medical conditions and their treatment, Dr. Bernstein presented the “Management of Frontal Fibrosing Alopecia.” This condition is a form of primary scarring hair loss. Dr. Bernstein chose to discuss this disease because it can be mistaken for common baldness; however, since the transplanted hair will be destroyed by the disease process, it is a contra-indication for hair transplantation. Since missing this diagnosis can lead to unnecessary and ineffectual surgery, an awareness of its signs and symptoms are important for every physician managing patients with hair loss.
On the panel on “Post Finasteride Syndrome,” Dr. Bernstein was part of a group that reviewed the latest studies on the efficacy and safety of finasteride in the treatment of androgenetic alopecia. They discussed possible adverse events including claims of persistent sexual dysfunction (Post Finasteride Syndrome) and concerns relating to prostate cancer. They also discussed the challenges that arise in caring for patients when scientific research and the mass media give conflicting information.
In the Symposium “Question the Expert,” Dr. Bernstein presented a case of Diffuse Un-patterned alopeica (DUPA). This condition was first detailed by Dr. Bernstein in his landmark paper “Follicular Transplantation: Patient Evaluation and Surgical Planning,” that was published in Dermatologic Surgery in 1997. DUPA is a form of androgenetic alopecia that presents as rapid generalized hair loss in young adults. Besides being a significant psychological burden for young men and women, its identification is extremely important since medical intervention can have a significant positive impact when instituted early. On the other hand, a misdiagnosis that leads to surgery can result in a failed hair transplant and donor scarring that may become visible over time.
Dr. Bernstein was also the Keynote Speaker for the ARTAS International Users Forum. His presentation, titled “Follicular Unit Extraction: Then and Now,” discussed the evolution of FUT, FUE and Robotic-FUE and how it relates to today’s hair restoration practice. Of particular significance was the natural progression of FUE instrumentation from hand-held manual tools to robotic assisted hair transplantation. Dr. Bernstein explained that in the future, robotic capabilities will not be limited to graft extraction, but eventually will perform each aspect of the transplant including recipient site creation, and graft placement. See “Dr. Bernstein Gives Keynote Presentation On Robotic Hair Transplantation” for more details on the presentation and some photographs of the event.
Posted byQ: As a Propecia user, I was alarmed when I read headlines last year about a new study indicating very high rates of depression and erectile dysfunction caused by Propecia, with symptoms persisting even after the drug was stopped. However, when I read the articles, this “study” appeared to be survey of 61 men who had taken Propecia and already reported sexual problems who were then asked about symptoms of depression. These rates of depression were compared to a small survey of men who had hair loss but had never taken Propecia.
Anyone with a basic understanding of statistics would know such a survey was deeply flawed. First, it is a textbook example of a bad data sample — to get sound results you have to start with an unbiased and random group of people who took the drug, not a self-selected group of men already suffering symptoms. The study also confuses correlation with causation — because these men are suffering from ED or depression does not necessarily mean it was caused by the drug. Am I missing something here, or did the media just report these “findings” with no scrutiny on what was actually studied? — Jonathan, Brooklyn, NY
A: Jonathan, I think you’re right on the mark. The way the study was conducted raises a lot of concern about the accuracy of the findings. It is really important that additional data is obtained in a controlled way, as this will be most useful for physicians in advising patients. I addressed concern on these reports last year. The issue of persistent sexual dysfunction as a side-effect of finasteride (Post-Finasteride Syndrome) is an on-going issue that we take very seriously. I sit on the International Society of Hair Restoration Surgery (ISHRS) Task Force on Finasteride Adverse Events, so this is an issue that we watch very closely.
Posted byQ: I have heard that side effects from finasteride can persist even after stopping the medication. What is the most current information on this issue? — S.V., Short Hills, N.J.
A: For the past two years I have been on the International Society for Hair Restoration Surgery (ISHRS) Task Force on Finasteride Adverse Events and struggling to make sense of this issue. There seems to be a disconnect between the relatively low incidence of side effects that we, as physicians, see in our practices, what published controlled studies have shown, and what is now being reported on the internet and in some instances in the media. For example, a 2012 study by Sato of 3,177 Japanese men published the Journal of Dermatology, showed a 0.7% incidence of adverse reactions to finasteride 1mg and no persistent side effects after stopping the medication.
That said, there has been a recent increase in anecdotal reports of side effects from finasteride as well as reports of persistent side effects after the medication has been discontinued (referred to as “Post-finasteride Syndrome”).
The FDA
Based on post-marketing reports of sexual dysfunction, in April 2012, the FDA announced changes to Propecia (finasteride 1 mg) labeling to expand the list of sexual adverse events and that some of these events had been reported to continue after the drug is no longer being used. It is important to note that no new clinical studies were reviewed to evaluate these adverse events and that the FDA is not aware of any additional controlled clinical studies conducted to evaluate these adverse events or to determine their cause or duration. (see FDA Label Changes for Finasteride 2012)
The FDA states that despite the fact that clear causal links between finasteride (Propecia and Proscar) and sexual adverse events have NOT been established, the cases suggest a broader range of adverse effects than previously reported in patients taking these drugs. The FDA states that it believes that finasteride remains a safe and effective drug for its approved indications, but also advises that healthcare professionals and patients should consider this new label information when deciding the best treatment option.
The difficulty with interpreting anecdotal information is significant. The following need to be considered; first, sexual dysfunction, both temporary and persistent, is quite common in the general population and patients may have new-onset sexual dysfunction from some other, unrelated, cause and second, patients may have real (physiologic) side effects from the medication and then have psychological after effects. It is so difficult to sort these factors out.
The ISHRS
The Finasteride Symposium at the 2012 ISHRS, of which I was a panelist, explored safety issues with finasteride. Dr. Akio Sato presented his data (quoted above) suggesting that finasteride side effects are uncommon and that persistent side effects were not seen. Dr. Freedland, a urologist and featured guest speaker at the ISHRS symposium, questioned whether long-term effects of a slight elevation in estrogen levels could have adverse effects on the prostate. The panel discussed the paper of Dr. Michael Irwig at George Washington University that appeared in The Journal of Sexual Medicine this year. In his survey of 54 patients of men who had persistent sexual side effects three or more months after the discontinuation of finasteride, he reported that sexual dysfunction continued for many months or years in the majority of the patients.
Difficulties in interpreting this study are that it assumed that the patient’s sexual dysfunction were caused by finasteride when, in fact, there is no way of knowing that finasteride was the actual cause of the side effects (this would need a blinded, placebo-controlled study). A second reason that makes interpretation difficult is that, because there was selection bias in the Irwig survey, there is no way of knowing if these patients are representative of the population of men on finasteride. That said, the data presented by Dr. Irwig stresses the importance of having more clarity on the potential side effects of finasteride, since it is so widely prescribed.
It was clear from the presentations and questions asked, that many issues are still unresolved. All in attendance agreed that further research is urgently needed. In the short term, it is most important that all patients who are having problems can have easy access to doctors with expertise in this area, so that they can be diagnosed properly and treated.
Posted byQ: I recently visited my dermatologist regarding my hair loss, and after checking my hair he said I am showing signs of Androgenetic Alopecia (common baldness), and said if I don’t treat it, it will progress. From my research on the net, I figured he will put me on Propecia. In fact he put me on Avodart. When I told him it is not FDA-approved for hair loss, and Propecia is, he said Avodart is better and brings DHT down more, and Propecia is nothing next to Avodart. He told me to take it every day for 2 weeks, then every other day from then on as it has a long half life. From researching on the net, many hair restoration doctors rarely prescribe Avodart for hair loss due to some dangers. What is your opinion on this? — T.G., Darien, Connecticut
A: Although dutasteride (Avodart) can be more effective for male pattern hair loss, I would start with finasteride (Propecia) as many patients do great with it and the safety profile is better. The following are things I would consider before starting dutasteride:
- As you point out, dutasteride is not FDA-approved for hair loss.
- There is no data on its safety when used for hair loss. This is important since dutasteride has been only tested on an older population of patients (with prostate disease) rather than a younger population of patients needing medical treatment for androgenetic alopecia.
- These is no natural model for dutasteride’s combined blockage of both type 1 and 2 5-alpha reductase (finasteride blocks only type 2 5-AR and there are families that have this deficiency and have no long-term problems. This, by the way, is how the drug was discovered).
- The type 1 enzyme which dutasteride blocks is present in many more tissues of the body (including the brain) compared to type 2 (which is more localized to the skin).
- Although so far unproven, there is a concern that finasteride may produce side effects than can be persistent after stopping the medication (post-finasteride syndrome). It this does turn out to be true, the effects from dutasteride would most likely be significantly more persistent.
- If you start with finasteride and do have side effects, you will most surely have side effects from dutasteride; therefore, by taking finasteride first you will have avoided the potentially more problematic side effects from dutasteride
- You may respond well to finasteride, and so do not need to consider dutasteride
- Read about Propecia (finasteride)
- Read about Avodart (dutasteride)
- View before and after photos of medical treatment of hair loss
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