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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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Because spas are seen as places for nurturing and wellness, spa professionals are offering special treatments and products this summer that encourage safe skin care. The Skin Cancer Foundation reports that more than 90% of all skin cancers are caused by sun exposure. International SPA Association (ISPA) members want to help lower that percentage.
From sunscreens, lotions and moisturizers, to treatments and products that give the appearance of a tan without the need for the sun, ISPA members are offering consumers numerous safe ways to enjoy this summer. “With 2,500 members in 73 countries, ISPA’s network of spas and product companies can make a real difference in the skin care habits of consumers,” says ISPA president, Lynne Walker McNees. “With some 57 million Americans having visited a spa, the industry is dedicated to promoting positive health habits of spa-goers.”
In addition to products and treatments that offer sun protection or help repair skin already damaged by the sun, ISPA members also report an interest in the following offerings this summer.
- Facials featuring antioxidants and vitamins to replenish winter-worn skin.
- Body polishes and scrubs to get rid of sallow winter skin and allow skin care moisturizers to soak in more easily.
- Cooling and hydrating wraps and peels to help spa-goers beat the summer heat or cool down after too much time in the sun.
- Of course, pedicures to keep feet looking great in sandals and around the pool.
- And, as the No. 1 treatment, massage is popular year-round and can be customized for summer to include ingredients that offer soothing from the sun, such as aloe. Also, incorporating fruits, herbs, plants and flowers that grow in the warmer months are popular additions to massages offered in the summer.
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Exposure to cats shortly after birth raises a child's risk of eczema, new research suggests.
The study, which tracked 486 children until the age of 1, was presented Sunday at the American Thoracic Society International Conference in San Diego.
While 27.6 percent of kids with cats as pets developed eczema in that time, only 17.8 percent of kids without cats developed the dry skin condition.
On the other hand, being around two or more dogs in the home conferred a slightly protective effect, said lead researcher Dr. Esmeralda Morales, a pediatric pulmonary fellow at the University of Arizona, in Tucson.
"Other studies have found that having cats or dogs at home seems to be protective against allergic disease, so we expected to have similar findings," Morales said in a statement.
Morales noted that the children in the study who developed eczema by the age of 1 might still wind up having a reduced risk of asthma or allergies later in life. "The findings do seem to add more questions about pets and asthma and allergies. Since there are a lot of contradictory data out there already, clearly it's a topic that needs further research," she added.
A gene linked to eczema has been identified by an international team of scientists and the finding may help in the development of new treatments for the common skin condition.
The gene produces a protein called filaggrain, which helps the skin form a protective outer barrier. Reduction or absence of the protein, normally abundant in the outermost layers of skin, results in dry and flaky skin. This study found that about 10% of Europeans carry a mutation that switches off this gene.
"It was a really tough project, but because we had experience in this type of gene, we managed to crack it where others had failed," Professor Irwin McLean of the University of Dundee in Scotland, told BBC News. "We see this as the dawn of a new era in the understanding and treatment of eczema and the type of asthma that goes with eczema as well."
The findings appear in the journal Nature Genetics.
HealthDay News, March 21, 2006