Distant decisions

Jul 01, 2007, 4:00am

International report - In attempting to ban OTC hydroquinone, FDA could follow South Africa, Japan, Australia and the European Union, which have banned hydroquinone from cosmetic products, sources say. However, some of these areas are experiencing problems with black-market hydroquinone, experts add.

International report - U.S. restrictions on hydroquinone could follow similar action in South Africa, Japan, Australia and the European Union, all of which have banned the skin lightener from cosmetic products.

Some of these regions are experiencing problems with black market sales of hydroquinone, experts say.

"In 1998, a number of countries, including France and South Africa, banned the use of hydroquinone in any beauty products," notes Noah Scheinfeld, M.D., J.D., assistant clinical professor of dermatology at Columbia University, New York.

African preparations also contain hydroethanolic formulations of hydroquinone, which are believed to be more potent than hydroquinone used in the United States because they enhance absorption, says Henry H. Chan, M.D., clinical associate professor of dermatology, University of Hong Kong.

This, along with Americans' use of sunscreens, largely explains why exogenous ochronosis occurs much more rarely in the United States, he adds.

The European Union banned cosmetic use of 2 percent hydroquinone in 2001, out of concern about exogenous ochronosis and leukomelanderma en confetti (Kooyers TJ, Westerhof W. J Eur Acad Dermatol Venerol. 20:777-780).

In France, "Dermatologists can prescribe hydroquinone, but it's under our responsibility," and available only from compounding pharmacies, says Jean-Paul Ortonne, M.D., chairman, department of dermatology, University Hospital of Nice, France.

While U.S. dermatologists have enjoyed a long list of hydroquinone options, Dr. Ortonne says the situation in France is "completely different," with only one variant of hydroquinone - but not hydroquinone itself - available.

"There is a French company promoting 4 percent hydroquinone," he adds, "but to my knowledge it has not yet been approved by the French FDA."

Australia also allows hydroquinone sales by prescription only, says John LeGuay, M.D.

"I can get a compounding chemist to mix it" in concentrations up to 8 percent, combined with tretinoin and hydrocortisone, he says. "Four percent is probably not enough (to treat melasma) in this country because we have a lot of sunlight," adds Dr. LeGuay, a dermatologist with the Skin and Cancer Foundation Australia, Darlinghurst, New South Wales, Australia.

Similarly, he says Australian dermatologists can prescribe concentrations of up to 20 percent monobenzyl ether of hydroquinone (MBEH), which is toxic to melanocytes, for vitiligo.

In Japan, "The skin lightening market is much larger" than in the United States, says Zoe Draelos, M.D., clinical associate professor of dermatology, Wake Forest University School of Medicine, Winston-Salem, N.C., and a member of Dermatology Times' editorial advisory board.

"Pigmentation problems are more common in Asian skin and more socially unacceptable in these cultures," she says.

William Philip Werschler, M.D., assistant clinical professor (dermatology) at the University of Washington, concurs.

"My understanding from my travels in Asia has been that the lighter one's skin tone, that means the more time one spends inside" versus laboring outdoors, he says.

Regulations differ

From a regulatory perspective, the Japanese have a third category of drugs the United States doesn't have, called "quasi" drugs, Dr. Draelos says.

"That's where skin-lightening preparations fall," she says. Because these preparations rank between the FDA's over-the-counter and prescription categories, making direct comparisons is like comparing apples and oranges, she says.

Hong Kong permits sales of 2 percent OTC hydroquinone products and prescription products with concentrations of up to 6 percent, Dr. Chan says. Here, he says, "Hydroquinone has raised a few alarms because of the European ban.