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FDA Issues Advisory Regarding Labeling Changes For Lindane Products
The Food and Drug Administration (FDA) has 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, including 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 that highlights the most important safety issues associated with use of these products. The boxed warning contains information to inform both health care professionals and patients regarding the potential risks associated with the use and misuse of Lindane.
The warning emphasizes that the products have been, and continue to be, indicated as a second-line therapy for the treatment of scabies and lice. Given the potential for neurotoxicity, patients only should be treated with these medications if other treatments are not tolerable or other approved therapies have failed.
The new warning also states that Lindane Lotion and Lindane Shampoo are to be used with caution in patients who weigh less than approximately 110 pounds. 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 half of reported adverse events occurred in pediatric patients.
Because 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 also have shown that younger animals are more susceptible to the neurological side effects seen with Lindane use.
To aid in the prevention of serious adverse events, product package sizes will be limited to 1 and 2 ounces.
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, FDA is encouraging health care providers to 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.
For more information, visit the FDA Web site:
http://www.fda.gov/cder/drug/infopage/lindane/default.htm
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