Derms discuss FDA's proposed ban on OTC hydroquinone products

November 1, 2006

For decades doctors and patients have used hydroquinone products to reduce differentiations in skin tones.

Though considered safe therapies, doctors recognized a couple of minor side effects, the most serious of which was the possibility skin tones would actually darken in some patients. But with appropriate oversight doctors felt they could avoid that. While physicians could prescribe 4 percent hydroquinone creams and lotions, patients also had access to lower concentrations of 1 percent to 2 percent hydroquinone products in over-the-counter (OTC) preparations for less serious tonal variations.

Now the Food and Drug Administration (FDA) wants to ban the sale of those OTC products because of mouse studies that indicate the potential of carcinogenesis with hydroquinone. In fact, the inclusion of hydroquinone in cosmetics has been banned in Great Britain since 2001.

Not giving up yet

Ronald R. Brancaccio, M.D., who practices in New York City says, "It's interesting, because I wouldn't say I'm out of the loop, but I hadn't read anything about this. But I went back and looked it up and the studies are published in reputable publications, so I guess we need to look at it."

But, he emphasizes, that doesn't mean giving up on hydroquinone.

"Everybody has been aware of the short-term effects. Patients can develop ochronosis, but that has been known for years and occurs rarely. Mottling from over-lightening is also rare, and there can be temporary lightening in dark-skinned individuals, but again that's not a big issue because the skin returns to normal.

"These are short-term effects, and the ban refers to long-term effects. Short-term use under the supervision of the physician is probably safe, but one should take this message to heart and be careful on prescribing hydroquinone long-term for any patient," Dr. Brancaccio says.

Karl Heine, M.D., Henderson, Nev., thinks it a bit interesting how he heard about the proposed ban.

"I heard about it only recently and it came as kind of a surprise.

"I went to a seminar where a company was touting a new product that's supposed to rejuvenate the skin. One of the big things they were talking about was that it didn't have hydroquinone, so it was safe and everything else was really dangerous.

"I couldn't figure out their point so I asked around a little bit and that's when I heard about it. I certainly haven't stopped using hydroquinone as a result."

Regular follow-up

Joseph A. Muccini, M.D., Chesterfield, Mo., has heard back from his patients on the reports.

"It's certainly not changing the utility of the drugs. More patients are asking questions about them now and you have to talk about it a little more.

"I've always respected them because of the rare side effects that can occur.