These excerpts are taken from transcipts of the JOINT MEETING OF THE NONPRESCRIPTION DRUGS ADVISORY COMMITTEE AND THE DERMATOLOGIC AND OPHTHALMIC DRUGS ADVISORY COMMITTEE - CENTER FOR DRUG EVALUATION AND RESEARCH - FOOD AND DRUG ADMINISTRATION
Wednesday, July 16, 1997.

A little Background: 5% Minoxidil was originally submitted for approval for use by both men and women. It was rejected by the FDA for women because it was not proven to be substantially more effective than 2% in women and produced a higher incidence of unwanted facial hair growth (6.6% of women tested). This is an insight into the actual decision making process that resulted in the NOT FOR USE BY WOMEN warnings and admonitions on the label.

Please remember, Minoxidil is a drug and the doctors at the FDA take their jobs very seriously.
The awkward thing about the Minoxidil labeling requirements is that the FDA insists on pictures on the box that shown the areas where the clinical trials showed hair regrowth. Because it's on the top and in the front for women and towards the back for men you end up with two different boxes and because the market for women is smaller than men, a far lower availability of the womens' branded and properly labeled product at a reasonable price!

This information is presented strictly for it's authoritative and factual content.

Can Women use 2% Minoxidil packaged and labeled for Men?

The current Rogaine for Men 2 percent product was used as a control because it is similar to the Rogaine Extra Strength for Men product but does not have the label warnings against female use.
Essentially two outcomes are possible.  If Rogaine Extra Strength is attractive to women, a higher proportion will ignore the warnings and should select Rogaine Extra Strength for Men rather than Rogaine for Men.  If it is a yea-saying effect, a higher percentage should choose Rogaine for Men since it does not have the warnings.
As we can see, a considerably higher percentage of women indicated that they would buy Rogaine for Men, the 2 percent offering, than said would buy the Rogaine Extra Strength for Men, indicating that the labeling is in fact working to deter usage among women and that a powerful yea-saying tendency is at work.
We can speculate there might be other reasons as well.  For example, some of the women might be aware that both Rogaine for Women 2 percent and Rogaine for Men 2 percent are in fact the same product.  Yet, even given no choice and in the face of higher efficacy, women did pay attention to the warning.  We believe this supports the validity of the first choice-based test design.
In conclusion, we believe the carton label for Rogaine Extra Strength for Men has been successfully tested among both women and men.  This learning has allowed for strengthening of the label with important wording and package graphic changes which have in turn been retested providing acceptable levels of comprehension.
The Rogaine Extra Strength for Men label effectively communicates to men the important messages about the product's benefit/risk assessment of greater effectiveness with a possible increased chance of minor scalp irritation.
In addition, women are clearly being informed that the product is not intended for their own personal use and we feel confident that the overwhelming majority will heed the warning and not opt to use Rogaine Extra Strength for Men.
It's important to remember that we're talking about an unwanted cosmetic effect that is minor and reversible and that would occur among only a very small number of women among an already small group of women who would incorrectly opt to use the product.

Can Women use 5% Minoxidil?

We (Pharmacia -Upjohn) have shown based on our extensive clinical and commercial marketing experiences with Rogaine 5 percent that there are no significant medical consequences associated with the use of this product in the female population other than an increase in dermatologic events and occurrence of hypertrichosis.  This unwanted effect, which is cosmetic in nature and reversible, occurs in a small number of female users. 
Keep in mind that only 7 patients out of 301 females in our well-controlled clinical studies who were treated with Rogaine 5 percent chose to discontinue use of the product due to hypertrichosis.  13, or almost two-thirds, of the women with hypertrichosis chose to continue using Rogaine 5 percent.
I also remind you that Rogaine 5 percent is approved in 19 countries outside the U.S. for both males and females.
In addition, working with the FDA, we will continue to pursue the approval of Rogaine 5 percent in females. 


DR. TRANCIK:  What I'd like to do, as I mentioned in my presentation, if there is more in-depth discussion than I presented which was primarily presentation of our databases, our well-controlled clinical study databases, I would like to have two of our consultants get up and just give you a little 5-minute talk about hypertrichosis.  I'm sure they'll be able to answer your questions.  Thank you. 
First is Dr. Vera Price from San Francisco.
DR. PRICE:  I'm Vera Price.  I'm a professor of dermatology at the University of California, San Francisco.  I've been in clinical practice for over 20 years and have many patients who have been using Rogaine, and I've also been involved in clinical trials using Rogaine for Upjohn since the early 1980s.
As far as defining hypertrichosis, it's as Ron Trancik told you.  This is hair growing where it doesn't usually grow. 
In the case of minoxidil-induced hypertrichosis, it's usually above the lateral brows, on the sides of the eyes, sometimes across the malar region, and down the sides of the cheeks, and perhaps along the hairline.  It is not the coarse mustache, beard-type hair that we sometimes think of as hirsutism.
This hair with minoxidil ranges from being fuzz to fine, 3 to 5 millimeters in length.  It is pigmented.  I won't say the women like it.  They don't like it, but in my studies I had no dropouts actually with the 5 percent because the women liked the increased hair on their heads.  So, they were willing to put up with the hair on the sides of their face because they liked the increased coverage of their scalp.
As far as when it occurs, it varies.  It's frequently early, in the first months of use, but it can take as long as several months before they see it.  The important thing is that with continued use in the studies, the hair almost always, if it doesn't go away completely by the end of a year, it's much less, and that was interesting.  In the studies the women who continued the use of 5 percent minoxidil who had hypertrichosis, the small, say, 5 percent in my studies of women, who developed it, it tended to disappear by the end of a year or greatly reduce.  Of course, if they stop usage, it goes away in several months.

DR. THOMAS:  Good morning.  I'm Lorna Thomas.  I'm a dermatologist in private practice in Detroit.  Although my practice setting and my geographic area are different from Dr. Price's, my observations are very similar with respect to hypertrichosis in females using Rogaine.
Basically it is seldom seen.  It is not serious.  It does tend to diminish with time.  It does not really require any treatment because either it resolves spontaneously if you just leave it alone, or in some cases, because it's not thick, coarse hair, women will choose to bleach it a little bit so that it's less obvious.
For example, this is a patient of mine.  She's a 55-year-old black woman who has been using Rogaine for about 10 months.  I think you can see that she has a little hair here above the brow and just follow along with me as we work our way toward the hairline.  This is hypertrichosis.  This is her normal hairline.  She's doing beautifully on Rogaine.  She's getting good growth out in this area and throughout the head, but this was the extra hair that developed.
Now, she's pretty representative of what you see.  They get this hair right along here, sometimes also on the cheekbone.  She also has a little bit right in this area here along the sides of the face, and that's basically it.
She has chosen to do nothing about this other than bleach the hair down right around here by that earring because she is so delighted with what's happening up in here.  This woman's father was totally bald, and she began losing her hair some 25 years ago and she was very concerned about that, not so much about this.
DR. D'AGOSTINO:  That was very helpful, actually both of those.
DR. THOMAS:  Here's another picture.  You can see hopefully.  This is hard to capture down here because this is really kind of a peach fuzz consistency so it doesn't show up very well in a photograph.
Also, I'd like to point out that even this right here is relatively fine, soft kind of downy hair.  It's not the same as this hair out here, this terminal hair, and it certainly isn't anything like coarse beard hair, as Dr. price pointed out.  It's just a little fine hair. She's really quite representative of what you see.
DR. TONG:  Dr. Thomas, I have a question.  We've heard that this is a product that's going to be targeted for men.  You've shown us a patient here who has been successful with the 5 percent.  What advice would you give her once this product comes on the market and she goes --
DR. THOMAS:  No.  This patient is using 2 percent.
DR. TONG:  She's using 2 percent.
DR. THOMAS:  Yes.
DR. TONG:  I thought it was the 5 percent.  My question was, what do you say to your women patients who come in and ask for advice about a 5 percent product?  You would say, stay with the 2 percent?
DR. THOMAS:  If they're doing well with their scalp hair, absolutely, yes.
DR. D'AGOSTINO:  Kathleen?
MS. HAMILTON:  If the photograph that we saw was with 2 percent use, could you describe what differences might appear with 5 percent use by a woman?
DR. PRICE:  Yes.  We did see more incidence of hypertrichosis, as you've seen it here, with the 5 percent over 2 percent.  In my studies, about 5 percent of the women on 5 percent solution and about 2-3 percent using 2 percent solution.  As far as the amount, I think those women who are predisposed -- the way it looks is about the same, but you will see it a little more frequently in those using the 5 percent solution.
MS. HAMILTON:  And is the time period to reverse that condition the same, or does it take longer?
DR. PRICE:  I would tell all women that it's going to take them somewhere between 4 to 6 months and it could be 8 months to reverse.  But I do advise them not to do any hair removal because this will go away by itself when they stop the medication.
DR. McKINLEY-GRANT:  Dr. Price, this is just a quick question, but did you actually see more hair growth on the top of the head with 5 percent than 2 percent in your studies in women?
DR. PRICE:  In my studies I absolutely saw more hair with the 5 percent than with the 2 percent.  It was a clear difference.


Here are a couple of questions we get all the time from women so we have tried to dig up some answers or opinions from the powers that be.

Can Women use 5% Minoxidil?
Can Women use 2% Minoxidil packaged and labeled for Men?
Discount Minoxidil . com
Minoxidil and Rogaine Stop Hair Loss