The FDA Warns Against Lindane for Head Lice
Compiled by David Shaw for "It's Your Health"

The FDA (Food and Drub Administration) announced this past Friday that new warnings must be added to the labels of products containing lindane, which is used to treat head lice and scabies in school-age children. Using too much Lindane to treat lice infestations can cause deadly brain or nerve damage, federal health officials warned Friday, urging strict limits on its use. They said the prescription drug should not be used on babies and "with great caution" on children.

It is estimated that in the United States up to 1 million prescriptions are written each year to treat new cases of head lice and scabies, which occur mostly in school-age children. Since Lindane is absorbed through the skin, and because younger children have more skin surface area per pound of body weight than adults, the amount that is absorbed may result in higher blood levels of Lindane in children than that seen in adults. Animal studies have also shown that younger animals are more susceptible to the neurological side effects seen with Lindane use.

"The FDA's decision to leave lindane on the market is completely irresponsible and another example of the agency failing to put public safety first," said Dr. Sidney Wolfe of Public Citizen, a consumer advocacy group.

According to Public Citizen, the FDA has received reports of at least 17 deaths associated with the use of lindane and numerous reports of neurologic effects ranging from dizziness to seizures. The consumer advocacy group said these numbers also most likely represent only a fraction of patient injuries because only one in 10 serious adverse drug reactions are ever reported.

Because most of the serious adverse events reported with Lindane products are due to misuse and overuse, especially with the Lotion, product package sizes will be limited to 1 and 2 ounces. It is very important that patients understand the importance of using this medication in a manner consistent with the product labeling.

The agency said the boxed warning emphasizes that the lindane products are indicated as second-line therapies and are only to be used with caution on patients who weigh less than about 110 pounds.

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