Bernstein Medical - Center for Hair Restoration - Safety of Hair Loss Medication
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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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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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Q: You prescribed Propecia for my hair loss. I was wondering if the news report on Propecia side effects has altered your opinion regarding the safety of this drug? — N.D., Belle Meade, Tennessee

A: It has not changed. I believe you are referring to Dr. Michael Irwig’s study at George Washington University published in the Journal of Sexual Medicine. I was already aware of the study when I prescribed the medication for you and we discussed the risk of persistent side effects at your consult.

Although all types of data should be considered, it is important to realize that this was not a scientific study, but a survey. It had very significant selection bias. From this type of study, one can’t prove cause and effect relationships or even get a sense of actual incidences. These were patients who were recruited because they already had persistent sexual dysfunction. Since it is not clear if their persistent problems were directly due to the medication or from other factors, and since these patients were selected, rather than randomly assigned, the additional information can be gained from the report is very limited.

That said, the reporting of persistent side effects should not be taken lightly, but should be viewed in the context of all available data. It is extremely important for us to continue to be vigilant, as this is a very significant issue, but it is equally important not to make decisions on data sensationalized in the media. As a result of the finasteride data, some are presenting surgery as a more reasonable alternative than medication. For a young person, that is usually not the case.

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Journal of Drugs in DermatologyThe January 2012 issue of the Journal of Drugs in Dermatology contains an article, written by Drs. Schweiger and Bernstein, which is the first case study of eyebrow growth from the topical use of bimatoprost.

Latisse (bimatoprost) is a topical medication that is FDA-approved for eyelash growth. Some physicians have used the medication for “off-label” use, such as use with eyelashes and scalp hair. However, until recently, there had not been any published medical literature describing the off-label use.

In the case report, a 47-year-old Caucasian woman visited Bernstein Medical for an evaluation of hair loss in one of her eyebrows, also known as eyebrow hypotrichosis. The hair loss was gradual, but had become cosmetically significant, and so she became interested in treating her thinning left eyebrow.

At her evaluation, the doctor discussed treatment options with the patient, including Follicular Unit Transplantation (FUT) and medical treatment with bimatoprost. She decided on medical treatment, and so started a four month treatment regime.

At a follow-up visit four months later, the patient reported significant thickening of her left lateral eyebrow. […] Physical examination revealed increased left eyebrow density, hair length, darker color, slight skin pigmentation, and eyelash treatment.

The conclusion of the article states:

We report one of the first cases of topical bimatoprost for successful treatment of eyebrow hypotrichosis. Studies are needed to confirm the efficacy and safety of topical bimatoprost to treat eyebrow hypotrichosis.

Also noted is that if the efficacy and safety of the medication are confirmed through additional testing, it would be a viable non-surgical option for eyebrow restoration.

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