Hydroquinone for Hyperpigmentation: Is It Still the Gold Standard?
Do you remember when you could just pop over to Walgreens and get hydroquinone over-the-counter (OTC)? Yes, the good old days. I used to recommend it for years and then suddenly, it vanished from the shelves. Why? As a part of the CARES Act, hydroquinone was removed from OTC access because the FDA does not consider it GRASE or generally regarded as safe. What about the rest of the world? Japan, Australia and Europe, banned hydroquinone before the US followed suit.
Back in 2006, the FDA proposed a ban on OTC hydroquinone and recommended it for study by the National Toxicology Program (NTP). This ban came from FDA concerns that oral hydroquinone may cause cancer and over hydroquinone’s association with skin ochronosis. The cancer claim was based on rat studies, which showed that ingested oral hydroquinone might be a carcinogen, but this has not been confirmed with human studies. Even though the FDA proposed a ban, it recommended that hydroquinone could remain available for OTC use in the meantime. Kind of confusing, huh? Along came the CARES act, which changed the FDA process for how certain OTC drugs, including hydroquinone, are regulated in the US and boom–as of September 2020, hydroquinone is only available for prescription use! Many of us in the dermatology world were shocked by the announcement and/or unaware that it even happened. But like many other pieces of legislation, this little nugget was snuck in amongst the 996 pages of the CARES Act. Yes…996 pages!
Overall, topical 4% hydroquinone has a good safety profile. There have been no reported incidences of cancer from topical application of hydroquinone in humans. While skin darkening, ochronosis, is linked to hydroquinone, it is unclear if ochronosis is the direct result of hydroquinone use or other ingredients in its formulation or higher concentrations of hydroquinone available in many other parts of the world. Depigmentation is also a concern with topical hydroquinone. This is uncommon and more importantly, hydroquinone does not cause vitiligo. Vitiligo patients can safety use hydroquinone products to help with hyperpigmentation. Overall, hydroquinone has been used for decades topically in the US without serious or fatal side effects.
The main concern surrounding hydroquinone stems from misuse, prolonged unsupervised use or high concentrations not commonly prescribed. Due to the association with ochronosis, hydroquinone is often recommended in treatment cycles rather than continued long-term use. In addition, other players are available to improve hyperpigmentation, several of which are OTC or available in higher concentrations as a prescription. One of my favorites is thiamidol, which is available OTC and works well for many patients. Azelaic acid is another option, especially during pregnancy and efficacious for acne post-inflammatory hyperpigmentation. Tranexamic acid, which has been used both topically and orally, can have impressive lightening properties, especially for melasma. Other ingredients like kojic acid, licorice root and niacinamide might land on your label too for their lightening benefits. Finally, topical retinoids and vitamin C also tout lightening properties but I would argue that they are often less effective and often I am recommending them more for their collagen building and antioxidant benefits over their potential to help with hyperpigmentation. And if a topical regimen is not enough to achieve results, you’ve also got in-office procedures like chemical peels, microneedling, laser or IPL.
So, is hydroquinone the gold standard? It’s not so black and white. Modern hyperpigmentation management is personalized. Sometimes hydroquinone is the best choice. Sometimes another option is a better fit. Often, the most successful approach combines several ingredients along with diligent sun protection.
Trotter’s Take: Hydroquinone is an excellent treatment for many patients, but it isn’t the only tool in the toolbox for hyperpigmentation.
Want to lighten up and learn more about options for hyperpigmentation? Then listen to my latest podcast Dr. Hiliary Woolery-Lloyd.
