High Dose Minoxidil Products – Lack of Evidence for Safety and Efficacy?

Several online distributors now offer products that contain minoxidil in higher doses than have been approved by the U.S. Food and Drug Administration (FDA) or that contain minoxidil in combination with additional active pharmaceutical ingredients.

Although the FDA has only approved minoxidil at concentrations of two percent (2%) or five percent (5%) for the treatment of hair loss, some products available over the internet contain minoxidil at concentrations as high as 15%. Many are formulated with additional ingredients such as azelaic acid, retinoic acid, caffeine, and even finasteride (the active ingredient in Propecia®), in combinations that have not been reviewed by the FDA.

The FDA evaluates two major concerns when considering new drug applications – safety and efficacy. Until these products are tested in clinical trials, there is no way to ensure that they are safe or to know whether high doses of minoxidil even provide any benefit over products that have been approved by the FDA.

Misleading Marketing?

Some consumers may find the marketing of these products to be misleading because of references to the FDA or to claims based on FDA-approved products containing 2% or 5% minoxidil.

The website for MinoxidilMax claims to offer “effective hair regrowth products... for male pattern baldness (alopecia androgenetica)” with “unmatched effectiveness.” Their products are manufactured “by an FDA registered cGMP compliant facility,” contain “the only effective ingredient approved by FDA in topical hair regrowth solution,” and have “the maximum strength of FDA approved hair growth stimulator (15% minoxidil).”

Consumers who read further on the company's website may be surprised to find that their products are not FDA-approved and that “the statement on this website has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease.”

Another manufacturer, Perfect Image Solutions, offers high dose minoxidil products “specifically formulated to treat conditions associated with male pattern baldness (Androgenetic Aloepicia).”

The FAQ section of the website relies on the long history of FDA-approved minoxidil products like Rogaine® to imply that high dose minoxidil products must also be safe:

“How do I know using a high concentration of minoxidil isn’t an overdose?
Minoxidil has been on the market for over 20 years with an extremely low incidence of side effects, especially from topical application.”

Although claiming that the products are “clinically proven to yield unparalleled results in the field of hair loss,” manufactured in an “FDA registered cGMP compliant facility,” and that all ingredients, “including Minoxidil must meet all FDA guidelines,” the website does not provide any evidence of clinical trials demonstrating the safety or efficacy of its products.

FDA Takes Action

Earlier this year, Regrowth LLC, a well known distributor of high dose "specialty" minoxidil formulations (formerly sold under the name Xandrox), released the following statement on its website:

“We're very sorry to inform you that Regrowth LLC has to suspend all operations at this time. In an ongoing audit, the U.S. FDA has deemed our medications to be 'unapproved illegal drugs'.”

Regrowth LLC had been selling minoxidil formulations containing 15% minoxidil (three times the FDA-approved dose contained in products such as Rogaine® and Avacor Physicians Formulation®).

On May 25, 2011, the FDA initiated a recall of 57,999 bottles of Regrowth LLC's products, stating that “[t]hese products are unapproved drugs and may present potential health hazards.”1 Based on this recall, it would not be surprising if the FDA takes action to stop other distributors of high dose minoxidil formulations/combinations from selling unapproved drugs in the future.

Conclusions

At the time of posting this article, we are unaware of any clinical trials proving that products containing higher concentrations of minoxidil than 5% are safe or more effective than FDA-approved products containing 5% minoxidil.

In January, Dr. Glenn Charles, a member of the International Alliance of Hair Restoration Surgeons, commented:

“I have not seen any studies comparing 5% Minoxidil with higher % Minoxidil concentrations. I would imagine that the incidence of side effects might be higher with greater % of Minoxidil. However, many of the reported side effects might actually be caused by the other ingredients in these hair loss products containing Minoxidil.”

If you are still interested in experimenting with formulations containing high dose minoxidil or combinations with other active ingredients, it may be a good idea to consult with a physician before you begin using any such products.

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1. Enforcement Report for May 25, 2011: RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II. FDA.gov (accessed September 8, 2011).
http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm256794.htm