The first head lice treatment with benzyl alcohol as the active ingredient has received Food and Drug Administration approval for use in adults and children aged 6 months and older.
The newly approved agent (not yet named) is the first prescription product to kill head lice by suffocation. While the agent lacks pesticides contained in other FDA-approved products, the approval carries a strongly worded warning not to use the agent in premature infants, citing the risk of serious respiratory and heart- or brain-related adverse events such as seizure, coma, or death.
The gestational age of the participants was not known when the clinical study data were submitted to the FDA, Jesse Fishman, Pharm.D., medical information officer for Sciele Pharma Inc. (manufacturer of benzyl alcohol lotion, 5%), said in an interview.
The company recommends only using the product on babies of normal gestation age plus 6 months. Therefore, based on an average full gestation of 40 weeks, a baby born prematurely at 35 weeks could be treated when they reach 6 months plus 5 weeks of age, for example.
The April 9 approval was based on data from two safety and efficacy trials with a total of 628 children with active infestations of Pediculosis capitis; the children's average age was 7 years in one trial and 10 years in the other. The study participants underwent two 10-minute applications (1 week apart) of benzyl alcohol lotion, 5% or topical placebo. Scalp examination conducted 14 days after completion of treatment showed that active infestation was resolved in 75% of the participants on active treatment and 26% of those on placebo.
"The warning about not using [the drug] in premature infants is strong," Dr. Seth J. Orlow said in an interview. "Parents and prescribers will want to know how premature an infant must be to fall under the warning, and when an ex-preemie is no longer considered 'a premature infant,'" he said.
The potential for treatment resistance, however, might be lower with benzyl alcohol lotion, 5%, compared with traditional pediculocides, said Dr. Orlow, chairman of dermatology and professor of pediatric dermatology at New York University, New York. He had no relevant disclosures.
The official indication to treat children as young as 6 months with benzyl alcohol lotion, 5% is a plus, Dr. Orlow said. "In addition to other potential benefits, it will no doubt be attractive to some parents who wish to use a 'non-pesticide' type agent. On the other hand, benzyl alcohol is, of course, still a chemical."
The product should be applied only to the scalp or the hair attached to the scalp. Irritation of the skin, scalp, and eyes were commonly reported adverse events in the studies, as was application-site numbness.
Parents who have grown cautious of putting pesticides on their children's heads to treat lice infestations have long ago embraced home remedies. The Internet has thousands of Web sites devoted to alternative treatments for smothering head lice. Many involve coating the child's head with mayonnaise, Vaseline, margarine, olive oil, or some other relatively thick and occlusive, yet washable agent. It is still necessary to comb out the eggs.