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FDA approved hair loss drugs

There is little that men can do to stop from losing their hair, but there are some hair loss treatment options that may restore some hair loss.

Currently there are only two hair loss drugs that actually work. They have been clinically proven to have a real degree of effectiveness. These two medications, Propecia and Rogaine, are also the only two drugs that are approved by the Federal Drug Administration (FDA) for the treatment of hair loss.

Medications for hair loss can slow thinning of hair and increase coverage of the scalp by growing new hair and enlarging existing hairs. However, they need to be taken continuously. If the medications are stopped, any hair that has grown in will gradually be lost, and within 6 to 12 months your scalp will most likely appear the same as before treatment.

Propecia (finasteride) and Rogaine (minoxidil) work in completely different ways. Propecia is a pill taken once daily, while Rogaine is a liquid that is applied to the scalp twice daily. Neither Propecia nor Rogaine have been proven to restore hair in the frontal areas. For reasons yet unknown these drugs only generally work in regrowing thinning hair in crown area of the scalp. Only hair transplant surgery has been successful in restoring hair in the frontal hairline area once it has been lost.

Propecia (Finasteride)

Propecia (Finasteride) has been available since 1997 and is the first and only oral medication approved by the FDA for the treatment of male pattern hair loss. Propecia has not been proven effective in women and is not approved for women.

Propecia blocks the conversion of the male hormone testosterone into a more potent androgen dihydrotestosterone (DHT), the hormone mainly responsible for hair loss. DHT is not the cause of hair loss, as the cause is inherited tendency to lose hair. But, the expression of one’s heredity regarding hair loss can only occur in the presence of DHT.

Propecia helps regrow visible hair and reduces further hair loss. If you start taking Propecia you may see a decrease in hair loss beginning in as little as 3 months. And by 6 to 12 months, you may see new hair growth. If it doesn’t work for you after 12 months, it is unlikely to be of benefit. If you stop taking Propecia, you will likely lose any hair you’ve gained within 12 months of stopping treatment.

Propecia has been demonstrated effective in most men. In fact, in FDA-reviewed clinical trials, 2 out of 3 men on Propecia regrew hair, as measured by actual hair counts.

Clinical tests showed Propecia was very well tolerated. Only a very small number of men had sexual side effects, with each occurring in less than 2% of men. They included less desire for sex, difficulty in achieving an erection, and a decrease in the amount of semen. After stopping taking Propecia these side effects go away.

Propecia advantages
  • Convenient pill form administration - one pill taken once a day.
  • Effective in most men - the vast majority of men using Propecia experience some benefit from its use.
  • Stops hair loss from progressing.
  • Can help regrow lost hair.
  • Beneficial side effects such as the shrinking of the prostate gland in men susceptible to an enlarged prostate.

Propecia disadvantages
  • Propecia is not a cure for hair loss. It will only work over the long term if you continue taking it. If you stop taking Propecia, you will likely lose any hair you have gained within 12 months of stopping treatment.
  • Propecia is not approved for use by women.
  • May cause sexual side effects such as decreased sexual desire, difficulty in achieving an erection.
  • The continuous treatment with Propecia can be expensive.

Propecia is only available by prescription.

Rogaine (Minoxidil)

Rogaine (Minoxidil) was originally developed in tablet form as a drug for high blood pressure. Doctors noticed that people on minoxidil sometimes grew new hair, so the drug was reformulated for this purpose. Rogaine was the first FDA approved drug for the treatment of male pattern hair loss and still the only FDA approved treatment for women with hair loss.

Minoxidil is a over-the-counter medication approved for the treatment of androgenetic alopecia and alopecia areata. Minoxidil is available in a 2 percent solution and in a 5 percent solution. The makers of minoxidil recommend women only use the 2% concentration of minoxidil because they have not received FDA approval for promoting 5% minoxidil or minoxidil extra strength for use by women.

Minoxidil is typically applied twice a day to the area of the scalp being treated. The exact way that Minoxidil works to promote hair growth is not fully understood. The medicine is known to be a potent "vasodilator", which means that it causes the walls of blood vessels to relax and widen, thus allowing more blood flow to pass through them; but it is generally agreed by most experts that there is some other additional way that the drug works in relation to hair growth, which remains somewhat mysterious.

Topical minoxidil is much more effective at treating baldness that occurs on the top, or crown, of the head than it is at causing hair growth on other parts of the head. Clinical tests on the effectiveness of topical minoxidil in men with baldness on the top of the head showed that 48% of men who had used minoxidil for one year reported moderate to dense re-growth of hair within the treated area, 36% reported minimal re-growth while 16% reported no re-growth. Similar percentages have been reported in women.

Minoxidil is a treatment for hair loss, it is not a cure. If regular application of topical minoxidil is stopped, all hair grown in response to the therapy will be rapidly lost over the next 3 to 6 months.

Side effects of topical minoxidil are rare and generally minor. Most common is scalp irritation or itching. The blood pressure lowering effect of oral minoxidil does not occur with the topical formulation. There is a small risk for facial hair growth associated with use of minoxidil - a finding that may be a side effect of the drug or may be due to accidental application of the topical solution to the face.

Rogaine is available without a prescription.

Rogaine advantages
  • The only FDA approved treatment for women with hair loss.
  • Slows the progression of hair loss
  • Regrows some hair
  • Has a few side effects. When used as directed in lotion form the risk of serious side effects is very small.
  • Can be used by hair transplant patients. Many surgeons recommend using it within a few weeks after surgery to promote the growth of the transplanted hair follicles.

Rogaine disadvantages
  • Rogaine is not a cure for hair loss. It will only work over the long term if you continue using it. If you stop using Rogaine you will likely lose any hair you have gained.
  • Limited effectiveness. Rogaine treatment does not work on everybody with thinning hair due to inherited pattern hair loss. It is less effective for hair loss at the hairline than on the top of the head. It is less effective on large bald spots than small ones.
  • May not help men with severe balding.
  • Although Rogaine topical lotion is a colorless, odorless, and non-greasy liquid that dries quickly and without any visible residue, some people simply do not like putting lotions on their scalp.
  • High cost - it is not covered by health insurance schemes as it's considered a cosmetic.

"Off-Label" Treatments

"Off-Label" prescriptions are written by a doctor when a medicine is prescribed for a use it was not approved by the FDA to treat. Medications often have uses for which they are not specifically approved. Drugs often prescribed "off-label" for hair loss include:

  • Dutasteride (Avodart)4, is 5-alpha reductase inhibitor, works the same way as finasteride
  • Spironolactone (Aldactone)3
  • Flutamide, a pure selective antiandrogen, is sometimes used for female androgenic alopecia
  • Estrogens5 may be used for androgenetic hair loss in females
  • Ketoconazole (Nizoral)6
  • Tretinoin (Retin-A )2

References & Resources

  • 1. Physicians' Desk Reference. 59th ed. Montvale, N.J.: Thomson PDR, 2005.
  • 2. Bazzano GS, Terezakis N, Galen W. Topical tretinoin for hair growth promotion. J Am Acad Dermatol. 1986 Oct;15(4 Pt 2):880-3, 890-3.
  • 3. Hoedemaker C, van Egmond S, Sinclair R. Treatment of female pattern hair loss with a combination of spironolactone and minoxidil. The Australasian journal of dermatology 2007;48(1):43-5.
  • 4. Stough D. Dutasteride improves male pattern hair loss in a randomized study in identical twins. J Cosmet Dermatol. 2007 Mar;6(1):9-13.
  • 5. Georgala S, Katoulis AC, Georgala C, Moussatou V, Bozi E, Stavrianeas NG. Topical estrogen therapy for androgenetic alopecia in menopausal females. Dermatology. 2004;208(2):178-9.
  • 6. Piérard-Franchimont C, De Doncker P, Cauwenbergh G, Piérard GE. Ketoconazole shampoo: effect of long-term use in androgenic alopecia. ermatology. 1998;196(4):474-7.

Published: May 05, 2007
Last updated: September 16, 2013

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