ISSUE 1317
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The FDA has approved benzyl alcohol lotion, 5% (Ulesfia Lotion – Sciele) for treatment of head lice in patients ≥6 months old. The active ingredient is 5% benzyl alcohol; the vehicle is 5% mineral oil.
MECHANISM OF ACTION — Lice exposed to benzyl alcohol lose the ability to close their respiratory spiracles; the lotion vehicle then obstructs their airways and causes them to asphyxiate. Benzyl alcohol has no ovicidal activity.
CLINICAL STUDIES — In 2 unpublished, randomized, double-blind, vehicle-controlled clinical trials (described in the package insert), a total of 250 patients ≥6 months old with head lice received two 10-minute applications of the active treatment applied one week apart. Benzyl alcohol eliminated all live lice in 76.2% and 75% of patients examined 14 days after the final treatment, compared to 4.8% and 26.2% with the vehicle alone. Resistance to the drug has not
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Article code: 1317b
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