Bernstein Medical Center for Hair Restoration - Propecia Safety

Propecia Safety

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Q: 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.

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Q: 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:

  1. As you point out, dutasteride is not FDA-approved for hair loss.
  2. 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.
  3. 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).
  4. 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).
  5. 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.
  6. 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
  7. You may respond well to finasteride, and so do not need to consider dutasteride
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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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The 2011 study published by a research team led by Dr. Alfredo Rossi, is the first comprehensive investigation on long-term safety and efficacy of finasteride 1mg (Propecia).

In “Finasteride, 1 mg daily administration on male androgenetic alopecia in different age groups: 10-year follow-up,” the Italian research team sought to fill a gap in our understanding of the long-term effects of treating hair loss with Propecia. The study tracked hair growth in 118 men between the ages of 20 and 61, with mild to moderate hair loss, who were treated with 1mg finasteride. These patients were evaluated before treatment and then again at 1, 2, 5, and 10 years on treatment.

The result of testing found not only that Propecia works and is safe for use, but there were some other interesting findings as well. Only 14% patients experienced a worsening of hair loss, while 86% benefited from the treatment over this extended time period and efficacy of the drug was found not to reduce over time for the majority of patients.

One of the most interesting findings is that patients who had hair growth in their first year of treatment are more likely than others to have better hair growth after 5 years. About half of patients experienced good hair growth in their first year, and about 53% of those patients went on to see improved growth over time. However, of the group with unchanged or worse results in their first year, only 25% saw improved hair growth after 5 years. After 10 years, almost 69% of patients who experienced growth in their first year experienced continued growth. Only 32% of those who saw unchanged or worse results after their first year had growth at 10 years.

The authors concluded that a patient’s response to finasteride in the first year is a pretty good indicator of how effective long-term treatment will be for the patient. The better growth he experiences in his first year, the more likely he will have continued growth beyond 5 years of treatment.

Among other findings, the age of a patient did have a statistically significant effect on the outcome, as patients older than 30 years had better hair growth in the long term. On the topic of side effects, 7 subjects (5.9%) experienced them, and some of those patients remained in the study because of what they perceived as the benefits of the treatment.

In conclusion, the authors found that Propecia is a safe and effective hair loss medication, even when used long-term. It is effective in patients older than 40 years and it is particularly beneficial for patients over 30 and who are in early stages of hair loss. Perhaps the most important finding is that a patient’s response to finasteride after the first year of treatment can be an indicator of the patient’s success with the drug in the long-term.

Reference:

Rossi A, Cantisani C, Scarnò M, Trucchia A, Fortuna MC, Calvieri S. Finasteride, 1 mg daily administration on male androgenetic alopecia in different age groups: 10-year follow-up. Dermatol Ther 2011; Jul-Aug;24(4):455-61.

Download the Rossi study of finasteride long-term effects

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Led by Dr. A. Sato, a Japanese team of medical researchers published the largest finasteride study ever performed, “Evaluation of efficacy and safety of finasteride 1mg in 3,177 Japanese men with androgenetic alopecia.” It investigated the effects of finasteride over a 3 1/2 year period in men with androgenetic alopecia, or common baldness.

The study found that patients who had experienced hair loss for an extended period of time and were treated with finasteride exhibited notable hair growth. While a fairly small proportion of patients with a hair loss duration over 10 years exhibited “greatly increased” growth, 85% of patients with hair loss duration of more than 15 years experienced “moderate” or “slightly increased” growth. Physicians have thought that people with advanced hair loss do not respond as well as patients in the early stages of hair loss. However, in light of the results of this study, that determination should be reconsidered.

Further, the same study found that the initial age of a hair loss patient at the time of commencing treatment has little to no effect on the outcome. While the efficacy studies that are included in the Propecia package insert were conducted in men 18 to 41 years old, men over 41 appear to respond as well as the younger group. Adverse reactions occurred in only 0.7% of the study population and the Sato study found no increase in adverse safety events over time.

In summary, the Sato study showed an increased response rate to finasteride 1mg with increasing duration of treatment. In addition, it is effective in a larger portion of the male population with androgenetic alopecia than previously thought.

Reference:

Sato A, Takeda A. Evaluation of efficacy and safety of finasteride 1mg in 3,177 Japanese men with androgenetic alopecia. J Dermatol 2012; 39: 27–32.

Download the Sato study on finasteride

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