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Urgent FDA Lindane Public Health Advisory Given to Consumers
(from April 1, 2003)

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. A Lindane Medication Guide, designed to inform patients of the risks of lindane products and provide instructions for appropriate use of the drugs, must now be dispensed by the pharmacist with each new prescription. The boxed warning emphasizes that it is a second-line treatment, updates information about its potential risks, especially in children and adults weighing less than 110 pounds, and reminds practitioners that reapplication of Lindane Lotion or Lindane Shampoo is not the appropriate treatment if itching continues after the single treatment.

Currently, lindane (gamma-hexachlorocyclohexane) is approved for topical treatment of pediculosis and scabies in patients "who have either failed to respond to adequate doses, or are intolerant of, other approved therapies." Lindane has been on the market since 1951, but was labeled as second-line therapy in 1995 because there are safer alternative treatments that should be used first. Second-line therapy is defined as (1) the patient cannot tolerate the first-line drug of choice or (2) the patient has used the first-line drug of choice as instructed and the treatment has failed.

The health risks of using lindane-based shampoos and lotions are well documented. The risk of neurologic side effects associated with lindane is known from clinical trials, spontaneous post-marketing reporting data and literature reports. These side effects have ranged from dizziness to seizures. In post-marketing reports, neurologic side effects occurred in patients who misused lindane, as well as in patients who used lindane
according to labeled instructions. Three deaths due to Lindane use have been confirmed, although 17 deaths have been reported associated with lindane use. The three confirmed deaths all included use of lindane not in accordance with the label, including multiple topical applications or oral ingestion. Among adverse event reports in which the outcome was serious (resulted in hospitalization, disability or death), the very young and the elderly appeared to be more susceptible to lindane's adverse effects and had worse outcomes. In addition, patients who have conditions, such as HIV infection, or take certain medications that may lower the seizure threshold, should be prescribed lindane with caution.

These reports highlight the need to emphasize the potential toxicity of lindane in the product labels and educate healthcare providers and patients about the risks and how to minimize them, as well as to develop mechanisms to facilitate safe use once the drug is dispensed to patients.

Many alternatives to using toxic chemicals exist that treat lice and scabies, and are equally as effective, not to mention more protective of human health. Please view the following resources Beyond Pesticides has developed for the least toxic control of head lice. For further information, please contact Beyond Pesticides.

For more information about least toxic control of head lice read Beyond Pesticides head lice alternative factsheet. In addition, also read Getting Nit Picky about Head Lice.