Will the FDA recall Hydroquinone?
February 13th, 2007
This just in from the American Academy of Dermatologists:
"... a proposal by the U.S. Food and Drug Administration (FDA) would require products containing hydroquinone to be evaluated as new drugs. This means that more than 200 skin-lightening products — both prescription and over-the-counter — could soon vanish.
...
The FDA says this action is necessary because hydroquinone poses serious health risks. Topping the list of concerns are an increased risk of cancer and ochronosis (pronounced oh-kron-no-sis). The latter is a rare medical condition that causes pigment to accumulate in the skin with long-term use of hydroquinone creams. When ochronosis occurs, the skin exposed to hydroquinone develops a sooty darkening.
Evidence Does Not Support Proposal
Dermatologists point out that products made by reputable companies remain safe and effective. The increased risk of cancer has not been proven in humans. This data comes from studies conducted on mice and rats, not humans. Even in Africa where some dermatologists say use of skin-lightening products borders on abuse, reports of an increased cancer risk have not occurred.
As for the increased risk of developing ochronosis, the fact is that millions of people in the United States have used these skin-lightening products. About 200 cases of ochronosis have been linked to these products, making the risk extremely rare.
The American Academy of Dermatology (Academy) and other medical organizations disagree with this FDA proposal...
Alternatives Not Safe
Many dermatologists fear that people looking for an alternative to their favorite skin-lightening cream may turn to unsafe products. Imported skin-lightening products often do not accurately list their ingredients. Some products contain mercury, others high-potency steroids. While illegal, these products do find their way into the United States. Using a product that contains a high-potency steroid can cause paper-thin skin, steroid-induced acne, and stretch marks.
Other imported products contain much higher levels of hydroquinone than currently allowed in the United States. These high levels can cause skin irritation and visible, light-colored halos around the treated skin."
I'm always a little suspicious of the FDA's timing. Some products zoom through, others are held up for years. And whether intentional or not, the lag time creates a boom time for the competition. Just ask the makers of Restylane, who have been patiently waiting for their Fine Lines dermal filler to get through the FDA for years. Meanwhile Inamed (makers of collagen-based fillers) is mopping up that part of the market.
It does suggest major politics at work. In this case, there is one prescription-strength hydroquinone cream (the article doesn't state which) that has already undergone additional testing and would not be subject to this recall. Hmmm....
Now, hydroquinone at the prescribed 4% strength carries a very, very low risk of complications beyond irritation (redness, possible rash). Why - given all the systemic drugs that pose a much higher risk, is hydroquinone suddenly being re-evaluated? Search me.
If you would like to subscribe to the American Academy of Dermatology's monthly e-newsletter, click here.
