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October 31, 2016

FDA Approved Treatments for Hair Loss

FDA approved treatments for hair lossFDA Approved Treatments for Hair Loss

Nobody wants to lose their hair. And, hair loss is a bigger problem than you might think even for women. Forty percent of women over age 40 report noticeable hair loss. But, there is some good news for hair loss sufferers. There are FDA approved medical treatments for hair loss.

Before we get into treatments for hair loss let’s discuss how hair grows.

How Hair Grows

At any moment about 85% of our hair follicles are growing hair and 15% of the follies are resting or dormant. A hair typically grows for 6 years and then the follicle will go dormant for a period. Under normal circumstances we loss 50 to 100 hairs a day. The typical hair loss sufferer loses 150 or more hairs a day and when the new hair comes in it comes in thinner and shorter than previously. This happens repeatedly over the individual’s lifetime until eventually the follicle produces no hair.

Hair Loss Treatments

Effective treatments for hair loss target androgenetic hair loss which occurs in both men and women. Let’s look at the different treatments, first in men, and then in women. Some treatments are the same in both sexes.

As many as 86% of men will see some hair growth with one of these treatments. Below are effective treatment for hair loss in men and then women. Those treatments that are in bold are FDA approved but the others can still be effective.

Hair Loss Treatments for Men

  • Finasteride (also known as Propecia and Proscar)
  • Minoxidil
  • Low level laser therapy such as Theradome® and Capillus®.

Finasteride and minoxidil are both more effective in preventing hair loss and inducing some hair regrowth when used earlier in the balding process.

Finasteride and minoxidil are the only two FDA approved treatments for hair loss in men.

Low level laser therapy is FDA cleared for hair loss. See below for discussion on FDA approved and FDA cleared. We discussed low level laser therapy in this article and will not address it further here.

Treatments for Hair Loss Women

  • Minoxidil (also used in men).
  • Spironolactone (also known as Aldactone)
  • Cimetidine (also known as Tagamet)
  • Cyproterone acetate
  • Estrogen/progesterone
  • Ketoconazole (also known as Nizoral)
  • Finasteride (also used in men)
  • Low level laser therapy

Minoxidil is the only FDA approved treatment for female hair loss. But, again the other hair loss treatments may be effective for some women.

What FDA Approval Means

For a drug to be FDA approved a drug company has to seek approval and then conduct clinical trials showing safety and efficacy. It can cost a billion dollars to get a drug FDA approved. The other hair loss treatments for women are already FDA approved for other conditions and drug companies may not see a big enough advantage to seek FDA approval for those drugs for hair loss. For drug companies the  decision to seek FDA approval for additional medical conditions for a drug is largely a financial decision.

FDA approval means drug companies can specifically market a drug for that specific condition but once a drug is approved physicians can prescribe a drug “off-label” for other conditions as they see fit. So FDA approval does not limit how doctors can use a drug. It limits how drug companies can market a drugFor instance, the manufacturer of Tagamet cannot market Tagamet for hair loss as it is not FDA approved for hair loss.

FDA clearance means that FDA has determined that a medical device to be substantially equivalent to another legally marketed device. FDA clearance generally applies to low risk interventions whereas FDA approval is reserved for higher risk interventions.

How Hair Loss Treatments Work


As we discussed in Hair Loss Causes in Men: Learn the Facts, excessive production of dihydrotestosterone (DHT)is the main factor behind androgenetic hair loss. Some testosterone naturally gets converted into DHT by way of an enzyme called  type II 5 alpha-reductase

Finasteride inhibits type II 5 alpha-reducatase. A one mg dose daily of finasteride reduces DHT levels by 60% and that 60% reduction stops hair loss in 86% of men. And, in clinical trials 65% of men reported a substantial increase in hair growth.

The American Hair Loss Association recommends finasteride as the first line treatment for hair loss in men. Results are better when start early in the balding process. Once a hair follicle dies nothing will stimulate it to regrow hair.

Finasteride is marketed under the brand names Propecia and Proscar. Proscar came out first for the treatment of enlarged prostate glands and comes in a 5 mg dose. A “side effect” of Proscar was hair growth and subsequently finasteride was studied and approved for hair loss at a one mg dose.

There is one potential downside to finasteride and we have seen this happen to men including males in their early 20s. Some DHT is necessary for a healthy libido. Dropping DHT too low with finasteride can lead to low libido and erectile issues. So we recommend that DHT levels be monitored and only the smallest effective dose of finasteride be used to manage hair loss. This means it may not be necessary to take finasteride everyday – just enough days a week to control hair loss.


Minoxidil was the first FDA approved treatment for male pattern hair loss. Minoxidil was originally released as a blood pressure pill. Like finasteride it was noticed that some men grew hair while taking minoxidil.

Whereas finasteride is a pill minoxidil for hair loss is applied directly to the hair and scalp either in a foam or solution. The results with minoxidil are not as impressive as those from finasteride but it can be obtained over the counter not requiring a prescription like finasteride.

Minoxidil works by prolonging the growth phase of the hair follicles and widening the hair follicles.  The exact mechanism by which it does this in unknown. It does not affect DHT levels or binding.

5% minoxidil is approved for men but only 2% minoxidil for women, though women can obtain 5% minoxidil through prescription from their physician.

About 60% of men will notice some improvement in vertex balding (crown of head) with a 10% to 12% increase in hair density. One well-designed study on men found that minoxidil was very effective for 15.9% of men, effective for 47.8%, moderately effective for 20.6%, and ineffective for 15.7%

For women about 13% will report moderate hair growth and 50% minimal hair growth with minoxidil. Another study showed that 60% of women realized some hair growth with minoxidil.

The following treatments are used to treat hair loss in women. They are not FDA approved.  Most of them work for hair loss as they are anti-androgens.


Spironolactone is a water pill. It is also an anti-androgen limiting production of androgens including DHT in the ovaries and adrenal glands. It also blocks DHT from binding to androgen receptors on the cells thus preventing hair loss.


Cimetidine is a histamine blocker and is used to treat gastrointestinal ulcer. It is marketed under the brand name of Tagamet. It has relatively powerful anti-androgen effects and blocks DHT from binding to receptors on the hair follicles. It is not effective for men as it would require large doses that would have a feminizing effect on men.

Cyproterone acetate

Cyproterone acetate is also an anti-androgen and is used to reduce sex drive in men with overly aggressive libido. It is also effective for women with androgenetic alopecia by blocking the binding of DHT to cell receptors much like spironolactone.

Estrogen and Progesterone

Estrogen and progesterone are prescribed for the many signs and symptoms related to perimenopause and menopause. Many women notice an added benefit to hormone replacement therapy, especially with bioidentical estrogen and progesterone replacement and that is … thicker hair and healthier hair


Ketoconazole is an antifungal therapy. It is also an anti-androgen and blocks production of testosterone in men and women. It comes in a 2% Nizoral shampoo which requires a prescription. A 1% over the counter formulation is also available without a prescription. It is used to treat other scalp conditions too.


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Dr. Joe Jacko

Dr. Joe is board certified in internal medicine and sports medicine with additional training in hormone replacement therapy and regenerative medicine. He has trained or practiced at leading institutions including the Hughston Clinic, Cooper Clinic, Steadman-Hawkins Clinic of the Carolinas, and Cenegenics. He currently practices in Columbus, Ohio at Grandview Primary Care. Read more about Dr. Joe Jacko

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