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Lindane Facts: The Truth About Lindane

Points of View on Lindane

Food and Drug Administration

After repeated and extensive review of the scientific and medical evidence on lindane, the Food and Drug Administration (FDA) has consistently determined that there is a need to preserve lindane medications as viable alternatives for patients with scabies, head lice and pubic lice who have limited treatment options. With each review, the FDA has determined that the health benefits of lindane prescription therapies outweigh the risks when used properly. (See Lindane Regulatory History)

Lindane is FDA approved as a second-line medication

The FDA is responsible for ensuring that safe and effective medications are available to Americans. Medical and scientific experts at the FDA recognize that all drugs are associated with risks. Their job is to carefully review drug information to assess the level of risk relative to the health benefits of disease treatment.

Under applicable law, the “FDA is the expert Federal public health agency charged by Congress with ensuring that drugs are safe and effective” based upon “a comprehensive scientific evaluation of the product’s risks and benefits under the conditions of use prescribed, recommended, or suggested in the labeling (21 U.S.C. 355(d)). FDA considers not only complex clinical issues related to the use of the product in study populations, but also important and practical public health issues pertaining to the use of the product in day-to-day clinical practice, such as the nature of the disease or condition for which the product will be indicated, and the need for risk management measures to help assure in clinical practice that the product maintains its favorable benefit-risk balance.”1

FDA Assessment of Lindane

FDA lindane assessment memorandum:2

“FDA has determined that lindane products have benefits that outweigh risks when used as directed.” (FDA Public Health Advisory on Lindane)

Further Reading

For additional information about the FDA’s viewpoint on lindane, please visit http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110452.htm.

Please See Important Safety Information on Lindane

References:

  1. Department of Health and Human Services, Food and Drug Administration, [Docket No. 2000N-1269] (formerly Docket No. 00N-1269) January 24, 2006.
  2. U.S. Food and Drug Administration (FDA). FDA Public Health Advisory: Safety of Topical Lindane Products for the Treatment of Scabies and Lice. March 28, 2003. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110845.htm.