Bernstein Medical - Center for Hair Restoration - Persistent Sexual Dysfunction
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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.

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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.

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Q: 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.

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Q: Dr. Bernstein, I am an attending at Mass General Hospital in Boston and would like to ask you regarding your experiences using finasteride for male androgenetic alopecia. While I have not noticed any side effects in the patients that I have been treating, I increasingly get questions regarding side effects based on the recent media attention to reports of potentially permanent problems regarding libido or erectile dysfunction. I know that in the literature there is a slight increase of reversible sexual dysfunction (~4% vs. ~2% in placebo) with Propecia, and no convincing evidence to date in the medical literature that have used controlled studies regarding permanent problems even after discontinuing Propecia. — S.Z., Boston, Massachusetts

A: That is correct.

Q: I know that you have treated many patients over a long period of time, and I was thus wondering what your take is on potentially permanent sexual dysfunction after taking finasteride. Have you seen any convincing reports/patients or do you have any concerns regarding irreversible side effects?

A: I have seen 5 cases in over 10,000 patients on finasteride that complained of this but, of course, there is no way to know for sure if there is a cause and effect relationship. As you know, real side effects may be followed by psychological ones and if the sexual dysfunction has another cause, then stopping finasteride would have no effect on the symptoms. The incidence of intermittent or persistent sexual dysfunction in the general population of men is about 30%, so one would expect these numbers to be much higher just due to the normal incidence. It is really a difficult situation to understand. The experience that my colleagues and I have in our practices is much different than one would expect after reading the numerous anecdotal reports on the internet.

Q: Would you think it is safe to say that any potential sexual dysfunction is reversible after discontinuing the use of finasteride?

A: I don’t think that anyone knows at this point. The FDA is coming down on the side of caution and saying that it is possible, although it is not based on any new studies. If the phenomenon is real, the possible mechanism is not yet known.

Q: In the relatively few patients that I have treated with Propecia, they did not even report temporary problems regarding libido or erectile dysfunction. Do you think they are real or rather attributed to Propecia simply because the patient is made aware of these potential side effects?

A: I think that psychological effects may account for many cases. At this time, it is still not clear if a physiologic “post-finasteride syndrome” is real. A lot more work needs to be done before we have a definitive answer to this question.

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The central finding of a 2004 study led by Italian researcher Dr. Antonella Tosti, in which he and his team investigated sexual dysfunction in hair loss patients being treated for androgenetic alopecia, was that there was no statistically significant change in sexual function after four to six months of treatment with finasteride 1mg (Propecia).

The researchers used a questionnaire, called the abridged 5-item version of the International Index of Erectile Function (IIEF-5), to measure sexual function in the men in the study. The questionnaire, which is considered an internationally valid diagnostic tool for distinguishing between men with and without erectile dysfunction, asks the patients 15 questions on the topics of: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall sexual satisfaction. By administering the questionnaire both before and after treatment with finasteride, the researchers were able to determine if sexual function was impaired by the treatment.

The result of this investigation in the sexual function of 186 patients was that, “the erectile function of all patients remained stable after 4 to 6 months of treatment with finasteride 1 mg.”

Interestingly, the research team found that sexual side effects were actually less common than reported in the clinical trials of the drug. They suggest that this difference was potentially due to the fact that subjects in the clinical trials were made aware of the potential for sexual side effects, and were asked about these side effects upon each visit, which led to higher reporting of side effects than what would otherwise be the case.

Reference:

Tosti A, Pazzaglia M, Soli M, Rossi A, Rebora A, Atzori L, Barbareschi M, Benci M, Voudouris S, Vena GA. Evaluation of Sexual Function With an International Index of Erectile Function in Subjects Taking Finasteride for Androgenetic Alopecia. Arch Dermatol. 2004;140:857-858.

Download the Tosti study of erectile function and finasteride

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On April 11, 2012, the U.S. Food and Drug Administration (FDA) announced changes to the professional labels for Propecia (finasteride 1 mg) and Proscar (finasteride 5 mg) to expand the list of sexual adverse events reported to FDA as some of these events have been reported to continue after the drug is no longer being used (note that erectile dysfunction after stopping use of these drugs was added as a known event in 2011). The new label changes include:

  • A revision to the Propecia label to include libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug.
  • A revision to the Proscar label to include decreased libido that continued after discontinuation of the drug.
  • A revision to both the Propecia and Proscar labels to include a description of reports of male infertility and/or poor semen quality that normalized or improved after drug discontinuation.

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.

Propecia

Only a small percentage of men using these drugs have experienced a sexual adverse event. During treatment with Propecia, 3.8% of men had reported one or more adverse sexual experiences as compared to 2.1% men who did not receive Propecia (received placebo). This represents a 1.7% difference.

For Propecia, the FDA’s Agency’s Adverse Events Reporting System (AERS) database between 1998 and 2011 found 59 cases of reported sexual dysfunction that lasted for at least three months following discontinuation of Propecia, and included erectile dysfunction, decreased libido, problems with ejaculation and orgasm disorders.

The FDA has not established a cause and effect relationship between finasteride and the sexual adverse events that continued after stopping drug use. The FDA believes that finasteride remains a safe and effective drug for its approved indications. Healthcare professionals and patients should consider this new label information when deciding the best treatment option.

For more information, read this PDF document: Questions and Answers: Finasteride Label Changes.

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In response to anecdotal evidence of sexual side effects continuing after stopping Propecia (finasteride 1mg), the International Society of Hair Restoration Surgery (ISHRS) has published a press release for the hair restoration community about the safety and efficacy of the drug.

The release notes that scientific data gathered from extensive testing finds no correlation between persistent sexual dysfunction and Propecia:

The ISHRS reports that there is no evidence-based data substantiating the link between finasteride and persistent sexual side effects after discontinued use of the drug in numerous, double blinded, placebo controlled studies conducted evaluating the use of Propecia 1mg for hair loss.

The ISHRS statement also touches on the fact that the exact cause of sexual dysfunction can be difficult to diagnose:

Sexual dysfunction is a complex disorder, and Dr. Martinick noted that it often can be hard to pinpoint the exact cause – particularly when multiple factors such as nicotine, alcohol, prescription medications, stress, anxiety, fatigue and depression can contribute to erectile dysfunction (ED).

In the interest of hair loss patients around the world, the ISHRS has formed a task force to examine the anecdotal reports of persistent sexual dysfunction by Propecia users. It has also called on medical communities from a variety of disciplines — dermatologists, hair loss physicians, urologists, endocrinologists and sexual medicine specialists — to share data and experiences.

Visit our section on Propecia to learn more about the medication, its use, and side effects.

Read the full ISHRS press release here.

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