T96-24                                       Ivy Fleischer Kupec
April 3, 1996                                (301) 443-3285

FDA REQUIRES LABELING CHANGE
ON LINDANE-CONTAINING LICE TREATMENTS

     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.
                               -More-                         Page 2, T96-24, Lindane Lice Treatments
     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.
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