(dailyRx)

The FDA has approved a new prescription medication for treating head lice (Pediculosis capitis) infestation.

Benzyl alcohol lotion, 5%, received full market approval as a prescription medication for use in patients ages 6 months and older. The product is distributed by Sciele Pharma Inc., a subsidiary of Atlanta-based Shionogi Company. The lotion is the first head lice product approved by the FDA with benzyl alcohol as the active pharmaceutical ingredient.

"Head lice are a problem that impacts more than a million children each year and is easily transmitted to others," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "This drug is an effective first-line treatment to eliminate lice infestation and minimize disruption in the daily routines of families."

The safety and effectiveness of the lotion was demonstrated in two studies of 628 people who were at least 6 months old who had active head lice infestation. The subjects received two, 10-minute treatments of either benzyl alcohol lotion or a topical placebo one week apart. Fourteen days after the final treatment, more than 75 percent of the subjects treated with benzyl alcohol lotion, 5%, were lice free.

Common side effects of the medication include irritations of the skin, scalp and eyes, as well as numbness at the site of application. As with all medications, using benzyl alcohol, 5%, as labeled is important to maximize benefits and minimize risks. The product should be applied only to the scalp or the hair attached to the scalp.

The lotion is not approved for use in children younger than 6 months. Use in premature infants could lead to serious respiratory and heart- or brain-related adverse events, such as seizure, coma or death.

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Rita Chappelle
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