April 3, 1996

FDA REQUIRES LABELING CHANGE ON
LINDANE-CONTAINING LICE TREATMENTS

FDA investigated claims that lindane, an insecticide used in prescription-only treatments for both lice and scabies, caused neurological damage in children. FDA scientists reviewed the available data on this issue and determined that lindane is, in fact, generally safe and effective when used according to the approved directions, but that its overuse can be harmful. FDA's Dermatologic Drugs Advisory Committee previously examined this issue and made the same determination of safety and efficacy of lindane.

The reasons for the products' misuse may be connected with pruritus -- itching that continues after successful treatment -- due to the residual inflammation in the skin. When the treated children continue to scratch, some parents may continue to medicate beyond the recommended procedure.

In other cases, parents may be inclined to overuse the product in their zeal to treat children as quickly as possible. This increases the amount of lindane to which children are exposed and raises the likelihood for adverse reactions to occur.

Other scabies and lice treatments that do not contain lindane are available to consumers. FDA has recommended labeling changes that encourage lindane's use only for patients who have either failed to respond to adequate doses, or are intolerant of, other approved therapies.

Additionally, lindane products' labeling will advise health care providers and parents not to confuse prolonged itching with reinfestation. They should carefully consider when further applications are needed. The drug's label already warns parents that neurotoxicity, damage to nerves or nerve tissue, is a possibility among certain patients, especially infants.