8 NEWS APRIL 15, 2010 • INTERNAL MEDICINE NEWS FDA Panel Urges Restrictions on Tanning Beds

BY ELIZABETH risks and to discuss increasing fied that 25% of melanomas in MECHCATIE concerns about the heightened young women could be attrib- skin cancer risks associated with uted to UV tanning bed use. G AITHERSBURG, MD. — A the devices. The advisory panel Of the more than 1 million Food and Drug Administration unanimously recommended people per day in the United advisory panel has recom- moving indoor tanning devices States who are exposed to UV mended tougher restrictions on to a higher risk category, sub- radiation from indoor tanning indoor tanning devices, includ- jecting them to more controls devices, 70% are women, and

ing a ban on their use by people and requirements. COM most are aged 16-29. A total of under age 18. Currently, UV lamps and . 24% of female adolescents aged At a meeting March 25, most beds used for tanning are regu- 13-19 have used a tanning bed at lated by the FDA as class I de- least once in the previous year, members of the FDA’s General TOCKPHOTO S I and Plastic Surgery Devices Pan- vices, the lowest risk category. / according to the AAD. el supported such a ban as one (Band-Aids are also regulated FDA officials at the meeting measure to address the wide- as class I devices.) said they believe there’s evi- IDMANTAS

spread use and potential skin Panelists were divided be- ©V dence of a potential raised risk cancer risks of indoor tanning. tween recommending reclassi- Most of the FDA panelists and members of the AAD support a for skin cancer associated with Other panelists recommended fying tanning devices as class II ban on use of indoor tanning beds by people younger than 18. increased UV exposure from different controls to protect this devices, which require special tanning lamps. ■ age group from exposure to controls, or as class III, the high- associations recommend a of the University of Pennsylva- these devices, including required est risk category. Examples of broad ban on the sale and use of nia, Philadelphia, who said that Disclosures: Members of FDA informed parental consent. class II devices include medical these products for tanning, but dermatologists are seeing more advisory panels have been cleared The FDA usually follows the lasers and UV lamps used to at a minimum, the AAD says, young women with advanced of potential conflicts of interest recommendations of its adviso- treat dermatologic disorders; they should be banned for use in skin cancer, including mel- related to the products under ry panels, which are not binding. class III devices include breast minors under age 18. anoma, who have used indoor discussion. The meeting was held to dis- implants and injectable cosmet- Among those speaking dur- tanning devices. The chief of cuss whether current labeling of ic fillers. ing the public hearing portion of the dermatology service at ›Go to www.youtube.com/ tanning beds and lamps ade- The American Academy of the meeting was the president Memorial-Sloan Kettering, New ElsGlobalMedicalNews. Click on quately addresses their known Dermatology and other medical of the AAD, Dr. William James York, Dr. Allan Halpern, testi- Uploads and search for James. NEWS FROM THE FDA

New Form of OxyContin Okayed injection site, bruising, irritation, and arettes, and how manufacturers decide Benzoyl Peroxide Declared Safe A new formulation of OxyContin has discoloration, the FDA said. when to increase or decrease menthol After 2 decades of debate, the FDA has been approved by the Food and Drug levels. The committee also wants to issued a final rule declaring benzoyl per- Administration in an effort to curb abuse Rozerem Claims Draw Rebuke know what the substance does in the oxide to be safe and effective as an in- of the widely prescribed pain-relief opi- Takeda Pharmaceuticals misrepresents body—including chemosensory, neuro- gredient in over-the-counter topical acne oid medication. its sleep aid Rozerem (ramelteon) in logic, and behavioral effects—and how products. OxyContin will be reformulated into sales materials aimed at physicians who and why menthol is marketed to certain According to agency policy, benzoyl tablets that are harder to cut, crush, treat substance abusers by claiming the population groups. peroxide is now GRASE (generally rec- break, chew, or dissolve, the FDA said. product has “no likelihood of abuse and A number of health organizations ognized as safe and effective). In 1991, the Abusers commonly break down the pills no detectable toxicity,” the FDA’s Divi- have asked for menthol to be banned, in- FDA proposed to classify the agent as a so that more of the active ingredient oxy- sion of Drug Marketing, Advertising, cluding the American Medical Associa- category III agent, which meant that it codone is released when the drug is and Communications has charged. tion, the American Public Health Asso- needed more study. At that time, some snorted or injected into the bloodstream, In a letter to Takeda’s North American ciation, the American Heart Association, data suggested that benzoyl peroxide the FDA explained a written statement. division, the DDMAC requested that the and the Legacy Foundation. was potentially carcinogenic in animals. The reformulation was approved April 5. drug maker immediately cease dissemi- The Tobacco Products Scientific Ad- Subsequently, new data have allayed The new tablet is harder to crack, and nation of the materials. visory Committee met for the first time the agency’s concerns. “We now con- “attempts to dissolve the tablets in liquid Rozerem was approved in 2005 for since the FDA was given the power in clude that benzoyl peroxide can be ade- result in a gummy substance that cannot use by patients whose insomnia is char- June 2009 to regulate tobacco through quately labeled to minimize the risks,” be drawn up into a syringe or injected,” acterized by trouble falling asleep. It is the Family Smoking Prevention and To- the FDA noted in its final rule. The new the FDA said. not a controlled substance, as are com- bacco Control Act. labeling will include warnings to avoid The FDA is requiring the manufactur- petitors in the sedative-hypnotics class, unnecessary sun exposure and wear sun- er of OxyContin, Purdue Pharma, to but that difference alone does not “con- First Anti-Acne Lotion Approved screen, to not use the product on very conduct a postmarketing study on the fer added safety,” the DDMAC said. The The first retinoid lotion for the treat- sensitive skin, and to keep the product extent to which the new formulation ac- FDA is particularly concerned with a ment of acne vulgaris has received ap- away from the eyes, lips, and mouth. tually reduces abuse of the drug. bar graph in the materials that com- proval, the manufacturer announced on —From staff reports pares Rozerem with 18 hypnotic drugs March 22. Varicose Vein Treatment Gets Nod on “likelihood of abuse” and “toxicity” Differin Lotion 0.1% (adapalene) will VERBATIM Polidocanol injection was approved scores, with Rozerem scoring zero. be available by prescription in April for March 31 for treatment of varicose veins, However, Rozerem is associated with treating acne on the face and body of pa- ‘One of the great the FDA said. “numerous risks, including potential en- tients aged 12 years and older. Distributed by BioFarm Medical as docrine toxicity,” regulators asserted. The approval comes after positive re- mysteries in stroke is the Asclera, polidocanol is approved to treat sults were seen in two similarly designed huge racial disparities in small spider and reticular veins up to 3 More Data Sought on Menthol 12-week, multicenter, controlled clinical mm in diameter. The injectable agent The tobacco industry is being asked for studies comparing Differin 0.1% (Gal- stroke mortality.’ improves the appearance of varicose data about menthol cigarettes so that the derma) to a vehicle in 2,141 acne patients. veins by damaging the cell lining of the FDA can determine whether the additive In both studies, Differin 0.1% was blood vessels, thus causing vessels to should be restricted or banned, agency shown to significantly reduce inflam- Dr. George Howard, on the close and be replaced by less-visible types advisers said March 31. matory lesions. Dryness was the most estimated 40% higher mortality of tissue. Varicose veins affect half of The FDA’s new Tobacco Products Sci- commonly reported side effect, occur- from stroke in blacks, compared people age 50 years and older. entific Advisory Committee wants to ring in about 7% of patients during the with whites, p. 39 Common adverse reactions to polido- know how the industry manufactures first 2 weeks of treatment and decreas- canol include pain or hematoma at the menthol, how and why it is added to cig- ing thereafter.

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