FDA Talk Paper
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T03-19
March 28, 2003 |
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FDA Issues Health Advisory Regarding Labeling Changes for Lindane
Products
The Food and Drug Administration (FDA) today issued a Public Health Advisory
concerning the use of topical formulations of Lindane Lotion and Lindane Shampoo
for the treatment of scabies and lice. The advisory announces significant
updates to the labeling of these products. These labeling changes include
additional warnings and the addition of a Medication Guide to be distributed
directly to patients.
Labeling for Lindane products has been changed to include a boxed warning
which highlights the most important safety issues associated with use of these
products. The boxed warning contains information to better inform both
healthcare professionals and patients regarding the potential risks associated
with the use and misuse of Lindane.
The warning emphasizes that Lindane products have been, and continue to be,
indicated as a second-line therapy for the treatment of scabies and lice. While
FDA believes that the benefits of Lindane outweigh the risks when used as
directed, given the potential for neurotoxicity, patients should only be treated
with these medications if other treatments are not tolerable or other approved
therapies have failed.
The new boxed warning also states that Lindane Lotion and Lindane Shampoo are
to be used with caution in patients who weigh less that approximately 110 pounds
(50 kilograms). These products are not recommended for use in infants, and are
contraindicated in premature infants. These warnings are based on reports to the
FDA's voluntary reporting system which described approximately one half of
reported adverse events occurred in pediatric patients.
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.
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 instructions for use and information about adverse events will also be
provided to patients in the form of a Medication Guide. By law, the Medication
Guide must be dispensed by pharmacists directly to the patient with each new
prescription of Lindane Lotion or Lindane Shampoo.
Other changes in the labeling address FDA concerns of potential increased
risk of adverse reactions associated with the use of Lindane products in
immuno-compromised patients, such as those with HIV infection, or patients on
medications, such as antidepressants, that may increase the chances of having a
seizure.
Given the possible risks associated with the use of Lindane, healthcare
providers should consider this new safety information when deciding whether to
prescribe Lindane Lotion or Lindane Shampoo for patients who may be at risk for
serious adverse drug events.
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Additional
Information on Lindane
FDA/Website Management Staff
Web page created by tg
2003-MAR-28
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