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3/28/2003

FDA Adds Boxed Warning to Lindane Products

Cheryl A. Thompson

A boxed warning highlighting important issues with the use of lindane lotion and shampoo has been added to the labeling of the lice treatment, the Food and Drug Administration (FDA) announced today.

The warning covers four issues:

  • Lindane products should be used only as second-line treatment of lice infestation or in patients who cannot tolerate treatment with safer medications. (Permethrin 1 percent creme rinse and pyrethrins with piperonyl butoxide are considered by the Centers for Disease Control and Prevention to be safer medications than lindane for the treatment of pubic lice.) 
  • Infants, children, the elderly, patients with skin conditions other than lice infestation, and persons weighing less than 110 pounds may be at a greater risk than the rest of the population of suffering a serious neurotoxicity from lindane exposure. Seizures and deaths have even occurred after a single application of lindane lotion or shampoo. 
  • Use of lindane products is contraindicated in premature infants and patients with a known uncontrolled seizure disorder. 
  • Patients must be instructed on how to use their lindane product properly. A medication guide, which must be provided by the pharmacy with each new lindane prescription, was developed for this purpose.

Update, 14 April 2003—The Food and Drug Administration on Friday provided the following examples of medications it considers safer than lindane for the treatment of head or pubic lice infestation: 0.5 percent malathion lotion, available only by prescription; 0.33 percent pyrethrum extract with piperonyl butoxide shampoo; and 1 percent permethrin cream rinse.

Information was also added advising clinicians to carefully consider the appropriateness of prescribing lindane to patients with conditions that may increase the risk of seizure or who are taking medications that may lower the threshold for seizure.

Because FDA determined that most of the serious adverse events were caused by misuse or overuse of the lindane product, the agency has set a 2-ounce limit on the size of lindane containers. One-pint containers of lindane lotion and shampoo will no longer be marketed.