domingo, 1 de junio de 2014

Consumer Updates > Indoor Tanning Raises Risk of Melanoma: FDA Strengthens Warnings for Sunlamp Products

Consumer Updates > Indoor Tanning Raises Risk of Melanoma: FDA Strengthens Warnings for Sunlamp Products

Indoor Tanning Raises Risk of Melanoma: FDA Strengthens Warnings for Sunlamp Products

tanning bed 350x233

On this page:
Using sunlamp products such as tanning beds or tanning booths increases the risk of skin damage, skin cancer and eye injury, according to the Food and Drug Administration (FDA) and numerous other health organizations. A particularly dangerous result is melanoma, the deadliest type of skin cancer.
According to the American Academy of Dermatology and the World Health Organization, indoor tanning heightens the risk of developing melanoma by 59 percent, and the risk goes up with each use. Despite these risks, according to the American Cancer Society (ACS), thousands of Americans will opt for an indoor tan. The ACS estimates that nearly 13,000 people die each year from skin cancers—approximately 9,700 of which are from melanoma. The ACS predicts that in 2014, melanoma will account for 76,100 cases of skin cancer.
To help protect consumers and inform them about the risks of indoor tanning, FDA is changing its regulation of sunlamp products and UV lamps intended for use in sunlamp products. The changes strengthen the oversight of these devices, and require that sunlamp products carry a visible, black-box warning stating that they should not be used on people under the age of 18.
This change is due to concerns that the effects of UV radiation add up over time, and children and teenagers who are exposed to indoor UV radiation are at greater risk for skin and eye damage.
“There is increasing evidence that tanning in childhood to early adult life increases the risk of skin cancer, including melanoma,” says FDA dermatologist Markham Luke, M.D., Ph.D. In fact, according to an overview of studies published in the journal Pediatrics, melanoma is the second most common cancer in women in their 20s and the third most common cancer in men in their 20s in the U.S. Luke adds that many experts believe that at least one reason is the increased use of sunlamp products by U.S. teenagers and young adults.
The overview in Pediatrics suggests that doses of UV radiation emitted by high pressure sunlamp products may be up to 10 to 15 times higher than that of the midday sun, an intensity not found in nature. UV-A radiation penetrates to the deeper layers of the skin and is often associated with allergic reactions, such as a rash. This is not to say that outdoor tanning is safe. In fact, the World Health Organization has classified all UV radiation as a carcinogenic (cancer causing).

Stronger Regulations, Better-Informed Consumers

Manufacturers of sunlamp products (including tanning beds and booths) must comply with applicable FDA regulations for both medical devices and radiation-emitting products. Based in part on risk information and recommendations from experts at an earlier FDA Medical Device Advisory Committee meeting, the agency is reclassifying these devices from Class I (low risk) to Class II (moderate risk). FDA can exert more regulatory control over Class II devices, notes FDA medical device expert Neil Ogden. For example, once the reclassification is effective, sunlamp products will have to undergo a premarket review by FDA and comply with requirements relating to performance testing, software validation, and biocompatibility.
FDA is also requiring that certain user instructions and promotional materials for sunlamp products and UV lamps intended for use in sunlamp products include the following warnings and contraindications (a contraindication means that the risk outweighs the benefit):
  • the product is contraindicated for use on persons under the age of 18 years;
  • the product must not be used if skin lesions or open wounds are present;
  • the product should not be used on people who have had skin cancer or a family history of skin cancer; and
  • people repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.
“We believe the reclassification will not only strengthen oversight of sunlamp products, but also help consumers be better informed about, and protected from, this sort of exposure,” Ogden says.

Practices to Avoid

Certain practices involving sunlamp products are especially dangerous. These include:
  • failing to wear appropriate protective eye wear, such as goggles—this can lead to short- and long-term eye injury;
  • starting with long exposures (close to the maximum time for the specific sunlamp product), which can lead to burning. Because sunburn takes 6 to 48 hours to develop, you may not realize your skin is burned until it’s too late;
  • failing to follow manufacturer-recommended exposure times on the label for your skin type (some skin types should not tan with UV radiation at all, for example, those with skin that burns easily and doesn’t readily tan); and
  • tanning while using certain medications or cosmetics that may make you more sensitive to UV rays. Talk to your doctor or pharmacist first.
This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
Updated: May 29, 2014

No hay comentarios:

Publicar un comentario