| FDA REQUIRES LABELING CHANGE ON LINDANE-CONTAINING LICE TREATMENTS
April 3, 1996
FDA has recently received inquiries about its recent decision to require
manufacturers of certain scabies and lice treatments to caution consumers about
the active ingredient, lindane (gamma benzene hexachloride). The following can
be used to answer questions:
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.
FDA MEDWATCH
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