Category: Drugs

NOTE: The following comes to us from a longtime reader that wishes to remain anonymous. He’s gifted us with some insightful posts in the past about the FDA, LLLT, and clinical trial regulations. His email is as follows:

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The Journal of Sexual Medicine recently published an article that has been the source of several Balding Blog posts, including one that answered a reader who wondered if, “the study suggests up to 15% of men taking the drug might experience some form of sexual dysfunction” in context of “the warning label on Propecia (that) … only 2 percent of men might experience erectile dysfunction while using the drug…”.

As a fan of the Balding Blog and a clinical trialist (someone who interprets clinical trial data), and one who has no relationship to Merck or financial interest in finasteride use, I have reviewed the article:

• Dr. Rassman has correctly pointed out that this article is not a study per se, but a review of data in the literature from completed and published finasteride studies that included placebo groups.
• The review included 3 studies of men using finasteride (1 mg daily) for alopecia, 15 studies of men using finasteride (mainly 5 mg daily) for benign prostatic hyperplasia, and 2 for “none” listed as the condition.
• The 3 studies of men using finasteride for alopecia included a combined total of 1196 men receiving finasteride, and 1035 men receiving placebo.
• As Dr Rassman has nicely emphasized before, the “true” incidence of an adverse event (attributable to a drug) is the percentage of men who experience a side effect receiving an active drug minus the percentage of men who experience a side effect via placebo. It is important to emphasize that this equation implies no causality (i.e., if a man receiving a drug gets a side effect, it is attributable to his active drug or placebo regardless of other factors – such as diabetes – that may be causally involved).
• The largest incidence of sexual side effects among the 3 studies involving men with androgenic alopecia is from the smallest study involving only 286 men who received finasteride and were a considerably higher age (41-60 years) than men in the 2 other studies (ages 18-40 years). In older men, factors that contribute to sexual side effects (diabetes, coronary artery disease, and aging) are considerably more frequent. In this small study of 286 men, changes in sex drive were observed (over a period of 1 year of treatment and 1-year of follow-up) in 4.9% receiving finasteride and 4.4% receiving placebo (treatment effect of 0.5%). In the same study, erectile dysfunction was observed in 3.8% of men receiving finasteride and 0.7% of men receiving placebo (treatment effect of 3.1%). In the two larger studies – involving younger men – the incidence of erectile dysfunction was 0.5% (1.4 minus 0.9) in one study, and 0.75% (0.75% minus 0) in the other study.
• Taken together, these results are consistent with the incidence of sexual side effects noted in the finasteride (Propecia) US product label: decreased sex drive (1.8% finasteride vs. 1.3% placebo) and erectile dysfunction (1.3% vs. 0.7%).
• The “15%” figure contained in the Balding Blog post by a reader was based in part on the cited (and misleading) newspaper commentary from a business reporter that stated ”…up to 15% of men taking (Propecia) might experience some sort of sexual dysfunction.” Indeed, The Journal of Sexual Medicine article cites a study of 613 men aged 45-80 taking 5 mg finasteride daily for benign prostatic hypertrophy for 2 years. In this study, 15.8% of men receiving finasteride (compared with 6.3% of men receiving placebo) reported erectile dysfunction. This is 5 times the recommended dose for treating hair loss, though. The largest study, involving 2315 men aged 45 years or older (with prostate hypertrophy), showed the next largest effect on erectile dysfunction: 8.1% (finasteride) vs. 3.8% placebo. This latter figure is almost identical to the incidence of erectile dysfunction noted in the finasteride (Proscar) US label.

In summary, one can’t properly mix “apples and oranges” involving clinical trial data involving different doses of drugs with different patient populations and for different indications. The journal article offered no major insights to me but is a nice review of currently published work. To me, a significant issue of side effects is reversibility. Even a minor headache is devastating if due to an active drug and is not reversible.

Despite anecdotes from blogs, I have seen no case histories published in the medical literature of men using finasteride for androgenic alopecia who have developed irreversible erectile dysfunction that has been attributed to use of finasteride. I am not saying that such a phenomenon does not exist; I just have not read any well-documented case history. A newspaper commentary from a business writer that references a blog where a 32-year old man developed erectile dysfunction (“had pretty lousy quality erections otherwise”) of unknown duration 12 years after starting finasteride and who cites “(recent) experiences with a new sexual partner” is not compelling (to me).

I am a 24 year old male, and have experienced mild hair loss for the past 2 years or so, mostly in the temple region. However, the rate of hair loss has significantly increased in the last 8 or 9 months, and has expanded to the entire top of the head. The front is now very thin, and my scalp is plainly visible all over when the hair is wet. I began taking Propecia 3 months ago, and have not noticed any slowdown in the rate of hairloss. What I have noticed recently, is that my hair has become very oily (it has never been very oily before), and mild acne is beginning to form at the hairline.

So my two questions are:
1) Is the increased rate of hair loss, and sudden expanded hair loss region normal?
2) Is the oily hair and/or acne side effect of Propecia? Normal symptoms of hair loss? Or something else?

Thanks a lot for your great blog!

These are questions for your doctor. Remember, you’re asking about a prescription medication. You should pose questions about this sort of thing with your prescribing doctor.

In my experience, what you are reporting for the first three months with regard to seeing a benefit on Propecia is usual as it takes almost a year to see value. With regard to the oily nature that you are reporting, I have not seen this reported by my patients.

(male)
Hi, i use minoxidil 5% for about 5 months now with really great result !

But now, i see some facial hair over my eyes and over my eyebrows… Does this unwanted hair with continue to growth with time ? should i stop or simply remove it with laser or electrolysis ?

thanks

Those unwanted hairs may be a side effect from topical minoxidil. I would consult with a doctor before doing anything drastic like laser hair removal or electrolysis. I would guess that if it was a side effect from minoxidil, those hairs should shed after you stop applying the medication.

Another point to consider is always wash your hands after using minoxidil on your scalp. It’s possible that you still had some medication on your hands and then touched your face.

I was wondering…when a person begins taking Finasteride, they go thru an accelerated shedding period that lasts roughly 3-6 months. After this initial period of shedding, just say that the Finasteride works and stabilizes the loss. Does the person end up growing back the hair that was lost during the accelerated shed? What if it doesn’t grow back? Is this the price that you must pay to halt or slow down loss with Finasteride? Do you have to take your amount of hair a step down in order maintain whatever’s left?

What if you fall into that 20-25% category of users who don’t respond to Finasteride in terms of hair stabilization? You could end up just accelerating your loss for those 6 months for no reason at all. Whether you stay on it or off, after this period, you will continue to lose. This is a big risk for people thinking about taking meds.

Shedding after starting Propecia isn’t a common occurrence, but I’ve heard reports that it does happen on rare occasions. It is more common with Rogaine (minoxidil) use, though. If we assume that there was some shedding from Propecia, I do not have much faith that those hairs would grow back.

The “what if” part about “20-25% chances” to your question is moot… because if it happens to you, it is 100%. And I do not believe there is a “big risk”, because you are taking a medication to slow down the hair loss (not accelerate it). Please speak to your doctor and be sure to have your hair loss monitored with miniaturization mappings, so that any loss or gain can be charted.

Can Kenalog 5, when injected into the nose, cause mpb? Thanks

No. Male pattern baldness (MPB) is genetic hair loss. That means your genes are the reason for the loss, not any medication. Perhaps you’re just using bad terminology, though.

I’ve read some claims about using kenalog as a hair loss treatment, but this hasn’t been proven effective. If you took massive doses of kenalog, then it could cause hair loss, but I doubt that the dose would be high enough. With all that being said, it didn’t cause your genetic hair loss.

Snippet from the article:

Merck (MRK) is experiencing some rough PR issues on its hair-loss drug Propecia following a study that suggests up to 15 percent of men taking the drug might experience some form of sexual dysfunction. For years, the warning label on Propecia has said that only 2 percent of men might experience erectile dysfunction while using the drug, and if users stop taking the pills everything returns to normal

Read the full story — Why Merck’s Hair Loss Drug Could Make Its Income Statement Go, Um, Limp

This article is from a business-oriented site, so it examines more of the bad press and how it may harm Merck’s stock valuation. And with the Propecia patent expiring in a couple years, Merck would probably like to keep the damage control to a minimum. That being said, I believe the study they reference is actually just an analysis of existing studies. Still, articles like this need to be seen by everyone. Knowledge is power.

I tell those patients who have sexual side effects to see me about reducing the dose. The problem of course, is that if you stop the medication the hair loss will continue.

Hello Doctor! Thank you for all the information that you provide on this website for all of us who are dealing with hair loss.

I have a question about finasteride. I had a hair transplant procedure done about six and a half months ago and the grafts have been growing quite nicely. I am using finasteride to maintain the remaining hairs that have not yet minaturized and fallen off. Do I have to take that 1 mg dose at the same time every day in order to maintain its effectiveness? I know this applies to patients who are taking finasteride to treat their symptoms for BPH (benign prostatic hyperplasia) in order to maintain the effectiveness of the drug but does the same routine apply to patients who are taking it to treat MPB (Male Pattern Baldness)? And if this is the case, does taking the drug at different times during the day reduce its effectiveness?

Thank you for the wonderful service that you provide for people who want to do something positive with their hair loss.

We have answered this question many times in the past. In general, as long as you take the medication as directed (once a day) you should be fine. There is no “right” time to take Propecia. Taking it around the same time each day makes sense as well, but the most important time is the time you REMEMBER to take it.

I did some searching on your site and could not find an answer to my question, so here goes: I’ve been taking Propecia (or splitting Proscar) for over ten years. Two years ago, when the generic became available (from India), I purchased it. Within months I started losing hair, and the loss continued. I went back to Proscar about a year ago. No change in growth but still losing, just not as much or as rapidly. I’ve read similar stories on the internet. I just filled a new Rx from Costco with the Indian finasteride (because of the cost). Am I naive in thinking it was my age (58 at the time) and genetics that caused the loss, or do you think the Indian generic is not up to the brand’s standard? Have you heard similar stories?

Normally, I’d tell a patient or reader that if you believe your medication is not genuine because you get it from India, I would suggest you buy it from a reputable company in the United States. But you got your finasteride from Costco in the US, so I’d expect it would be fine. Plus, there are many large pharmaceutical companies in India (not sure which one you got) and the FDA permits them to import medication here. If you bought it online from a pharmacy that required no prescription, that would be a different story.

If you are losing hair (even at the age of 58) and you are treating it with finasteride, then you are treating genetic hair loss. Remember, the medication isn’t a cure, so it’s possible that it was just coincidental timing that you switched to a generic finasteride around the same time that medication started losing the battle to your genes.

Dear Dr. Rassman,

I believe that their is a possibility of very small subset of men experiencing continual sexual dysfunction from propecia after cessation of the medication. The underlying mechanism of why this happens may be similar to why a small subset of people experience continual sexual dysfunction after going off of SSRIs. This paper may offer some insight into what is going on in these rare situations when persistent side effects happen with these commonly used drugs.

Epigenetic side-effects of common pharmaceuticals: a potential new field in medicine and pharmacology.

It’s possible that there are a subset of men that experience epigenetic side effects. Thanks for sending this information. It’s more theory at this point, but interesting reading nonetheless.

Sometimes though, we must take a step back and look at what we are trying to do. If someone is scared of these side effects and do not want to start the medication, then it is their choice. If someone looks at the risks (or rather, the chance of this happening) and weigh it out with the benefits of what the drug can provide, they can make their own choice as well. I know I’ve said it many times before, but Propecia is an elective medication. I realize there are risks, but it is a medication I recommend to most of my patients as they understand the risks and benefits of ANYTHING that they do in life.