What Hair Loss Treatments Are Approved by the FDA?
2021-09-16
The U.S. FDA has approved only two medications to treat male pattern baldness and female pattern baldness (androgenic alopecia): minoxidil and finasteride. Although it’s not FDA-approved for hair loss, topical ketoconazole is sometimes used as an alternative and/or adjunctive treatment for people who don't respond to minoxidil or finasteride. A review of academic literature regarding the efficacy of ketoconazole for treating androgenic alopecia (AGA) indicates that ketoconazole is also a promising therapeutic for addressing AGA, though more trials may be needed. Other ingredients are frequently used by dermatologists in the treatment of hair loss as well, including tretinoin, though these are not approved specifically for hair loss.
Here's the story on FDA-approved hair loss treatments.
How is Male Pattern Baldness Diagnosed?
Dermatologists diagnose androgenic alopecia in men by evaluating the pattern of baldness, obtaining the patient's medical history, and asking about the prevalence of male pattern baldness in their family. The doctor may examine the scalp using a densitometer that magnifies hair follicles and hair roots. A densitometer can reveal whether a man's hair follicles are smaller than normal due to possible DHT sensitivity.
The Norwood Scale is also useful for determining what kind of hair loss treatment is needed to address specific types of hair loss progression. Composed of images of men in various stages of hair loss, the Norwood Scale is routinely used by doctors specializing in hair loss conditions.
Facts about Minoxidil (Rogaine)
Rogaine is the original brand name for minoxidil, a versatile type of antihypertensive vasodilator that can help reduce high blood pressure and treat androgenic alopecia. Minoxidil is available as an over-the-counter foam or liquid. When used as an anti-hypertensive drug, minoxidil requires a doctor's prescription, but topical minoxidil for hair growth is approved for use over-the-counter: it no longer requires a prescription (though it did in the ‘90s when first introduced).
Hair follicles receive rich amounts of nutrients and oxygenated blood due to minoxidil's ability to dilate blood vessels. Minoxidil also contains a nitric oxide agonist that seems to cause follicles to shed hair when they are in the telogen phase of hair growth. Follicles then quickly enter the anagen phase that allows for thicker hairs to replace thin or missing hairs.
How is Minoxidil Used to Treat Androgenic Alopecia?
Minoxidil works to treat male pattern baldness and female pattern baldness. Men with receding hairlines but not the characteristic horseshoe-shaped pattern of baldness indicative of androgenic alopecia may not always see desired results using minoxidil. In addition, minoxidil is not always recommended for unexplained hair loss, patchy hair loss, or hair loss attributed other conditions.
How much minoxidil a person uses depends on whether it’s formulated as a 2% or 5% topical solution. Minoxidil must be applied once or twice a day to provide the best results. In most cases, men using 5% minoxidiol begin seeing visible results in about four months.
What is the Difference Between 2% Minoxidil and 5% Minoxidil?
Structural and chemical differences between male and female hair follicles have led to research showing that 5% minoxidil works better on men with androgenic alopecia. Men and women can use 2% minoxidil to achieve similar results, but the amount of 2% minoxidil topicals needed to initiate hair growth is more than what is needed for men who use 5% minoxidil.
A 48-week, double-blind, randomized trial comparing 2% topical minoxidil, 5% minoxidil and a placebo involved nearly 400 men with androgenic alopecia. Researchers reported that, at the 48-week mark, results indicated that 5% minoxidil was "significantly superior to 2% minoxidil." Not only did men using 5% topical minoxidil respond faster to treatment, but subjects reported improved self-esteem and overall quality of life.
Facts About Finasteride (Propecia)
Originally developed to treat male benign prostatic hyperplasia (BPH), Propecia began intriguing doctors when men taking oral Propecia reported a particular side effect --hair regrowth in men with male pattern baldness.
Finasteride is the active ingredient in Propecia. Pharmaceutical chemists already knew prior to marketing Propecia that finasteride inhibited an enzyme needed to convert testosterone to dihydrotesterone. However, they didn't anticipate Propecia's ability to reduce DHT enough to treat male pattern baldness. In fact, men who are genetically predispositioned to experience male pattern baldness are either sensitive to DHT or have too much DHT in their hair follicles. .
Available by prescription only, finasteride is FDA-approved but may cause possible side effects men should know about, including:
- Problems with maintaining an erection
- Loss of sexual desire
- Breast enlargement
- Ejaculation delay/inability to ejaculate
Finasteride (1 mg) was approved in 1997 by the FDA for treating male pattern baldness. In the same year, the FDA also approved 5 mg finasteride (Proscar) for treating BPH only_. Proscar at this dose should never be used to treat male pattern baldness._
Studies involving women using finasteride for female pattern baldness have found the drug may interfere with fetal development. Women in their childbearing years should avoid taking finasteride due to the increased risk of birth defects. In addition, pregnant women should not touch broken or crushed finasteride tablets. This drug could harm the health of a male fetus if it is absorbed by the skin.
How is Finasteride Used to Treat Male Pattern Baldness?
Doctors prescribe finasteride in 1mg tablets to adult men with male pattern baldness. One tablet is taken daily, with or without food. Most men see results within four to six months of beginning treatment. If finasteride use is stopped, any new hair growth will likely be lost within one year. Finasteride only supports hair growth as long as it is taken. Once levels of finasteride in a man's bloodstream start dwindling, it can no longer prevent conversion of testosterone to DHT.
Contraindications for Finasteride
Some medications may reduce the effectiveness of finasteride and/or increase some side effects. No severe drug interactions with finasteride have been identified in dozens of trials and studies. However, the following drugs could moderately interact with finasteride:
- Luvox (fluvoxamine/SSRI)
- Fluconazole, itraconazole and other antifungal medications
- Ginseng
- Nefazodone (antidepressant)
- Terazosin (antihypertensive)
How Does the FDA Approve Hair Loss Treatments Like Minoxidil and Finasteride?
To ensure the safety of U.S. citizens, the Food and Drug Administration (FDA) puts all medications through a rigorous process of testing, retesting, and evaluating results. Minoxidil and finasteride have passed through four steps required by the FDA for approval: preclinical, clinical, NDA reviews and post-marketing. Following approval, finasteride and minoxidil manufacturing facilities were inspected for compliance with federally mandated protocols. Finally, pharmaceutical companies are required by law to submit regular efficacy and safety data for continuous evaluation and monitoring.
While these medications are the only two approved by the FDA, dermatologists use a variety of individual ingredients when treating hair loss. For instance, tretinoin is a commonly used retinoid that can help to accelerate skin cell turnover. When use on the scalp, it has shown evidence of improved hair growth, and many dermatologists use it in private practice.
Shapiro MD’s dermatologists have crafted a variety of options for men and women dealing with hair loss, and our telemedicine process makes getting a personalized and even prescription solution easy, if approved.