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The FDA is seeking to ban over-the-counter sales of skin bleaching drug products.
The FDA cites the possible risk ofand skin discoloration from hydroquinone typically found in these products.
However, those cancer studies were done on rats, not people.
"The actual risk to humans from use of hydroquinone has yet to be fully determined," the FDA states in its proposal, published in the U.S. government's Federal Register.
The type of skin discoloration noted by the FDA is called exogenous ochronosis, a darkening of the skin. The FDA cites research linking the condition to hydroquinone use.
The FDA isn't proposing a ban on prescription skin bleaching drug products. But all such products would need to submit a new drug application for the FDA's review.
Not all skin lighteners contain hydroquinone. The FDA knows of 200 products containing hydroquinone in strengths from 0.4% to 5%, about two-thirds of which "appear to be marketed as OTC [over-the-counter] drugs," says the FDA.
The FDA is taking comments on its proposal until Dec. 27.
WebMD spoke with dermatologist Susan Taylor, MD, of Society Hill Dermatology in Philadelphia, and the Skin of Color Center in New York about the FDA's proposal.
"I feel that hydroquinones are safe and effective treatment for pigmentary disorders," Taylor says. "I feel comfortable recommending that my patients continue to use hydroquinones if they have a pigmentary disorder."
"I think the evidence is quite weak with the link between hydroquinones and cancer," Taylor tells WebMD.
"Data on rats and mice cannot necessarily be extrapolated to human data," she says.
"In Africa, people have used hyrdoquinones for long periods of time ... meaning years, 10, 20, 30, years ... and at high concentrations," Taylor says. "We've not seen a proliferation of various types of cancers reported from that population.
Exogenous ochronosis is rare in the U.S., Taylor notes.
"If you look at the case reports, it's probably less than 200," Taylor says. "So it's really not a significant problem here in the United States."
Millions of Users
Taylor points out that "many patients have disorders that are truly disfiguring and devastating. And these conditions can be improved significantly with hydroquinone products."
"It's important therapy and it's used by millions and millions of people," Taylor says.
She says hydroquinone products are primarily used to lighten dark areas of the skin due to conditions including injury,, , and sun damage.
"So there are real problems and this is a real solution," Taylor says. She adds that filing new drug applications can cost millions of dollars.
"My concern is that we could lose prescription products that we have," Taylor says. "That would have major consequences, I think."
"It's safe, effective; it's the gold standard, and I think our patients would benefit from continued use for these problems. I think those three points sum it up for me," Taylor says.
SOURCES: U.S. Government Printing Office, Federal Register, Aug. 29, 2006; vol 71: pp 51146-51155. Susan Taylor, MD, Society Hill Dermatology, Philadelphia, Skin of Color Center, New York.
By Miranda Hitti, WebMD, August 30, 2006
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Unless it's continuously reapplied, sunscreen can actually attack the skin and leave it vulnerable to ultraviolet (UV) radiation, concludes a University of California, Riverside study.
The researchers found that, over time, molecules in sunscreen that block UV radiation can penetrate into the skin and leave the outer layer susceptible to UV, CBC News reported.
The study appears in an upcoming issue of the journal Free Radical Biology & Medicine.
"Sunscreens do an excellent job protecting against sunburn when used correctly," Kerry Hanson, a research scientist in the university's department of chemistry, said in a prepared statement.
"This means using a sunscreen with a high sun protection factor and applying it uniformly on the skin. Our data show, however, that if coverage at the skin surface is low, the UV filters in sunscreens that have penetrated into the epidermis can potentially do more harm than good," he said.
HealthNews Day, 8/29/06
Botox injections can help facial wounds heal with less scarring, a small study finds.
"This is the first medication found to minimize scarring," senior author Dr. David Sherris, professor and chair of the department of otolaryngology at the University at Buffalo, said in a prepared statement.
His team published the study in the August issue of Mayo Clinic Proceedings.
The study included 31 patients who suffered wounds to the forehead or had surgery to remove skin cancers from the forehead, an area that's particularly susceptible to scarring. The patients received either an injection of Botox or saline within 24 hours after wound closure.
Photographs were taken at the time the patients received the injections and again six months later. The photographs were reviewed by two facial plastic surgeons who weren't involved in the study. They rated the patients' wound healing on a scale of zero to 10, with 10 representing the best result. The two surgeons' scores were averaged to reach a final score for each patient.
The median scores for wounds injected with Botox were 8.9, compared to 7.1 for wounds injected with saline.
"The result is of substantial interest in the field of scar treatment. When a wound occurs, especially on the face, people are always worried about the scar. We can now try to improve scars with these injections," Sherris said.
The study was funded by a clinical research grant from the Mayo Clinic.
HealthDay News, August 24, 2006
Rancho La Puerta breaks ground on a 4,500-square-foot spa cooking school. La Cocina Que Canta, Spanish for “The Kitchen That Sings,” will feature a large hands-on kitchen classroom, cookbook library and culinary gift shop. The school is scheduled to open in spring of 2007. 800-443-7565
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Natural cosmetic sales are booming in France, increasing 40% in 2005, according to Organic Monitor, a business research and consulting company. Due to growing awareness of chemicals in products, consumers are shying away from traditional staples and opting for natural toiletries, makeup and hair care. A new study by Organic Monitor shows that sales are continuing to rise in 2006. In addition, with more than 1,700 choices on the market, organic products account for about one-fourth of all natural cosmetic sales.