Lindane Warning

FDA Issues Health Advisory Regarding Labeling Changes for Lindane Products

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.

This is an important warning .. since many sources (such as this "tip" in American Family Physician) list Lindane as one of many treatment options – without advice about which product should be considered first-line and which should be reserved for resistant cases.


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