What is lindane?
Regulatory History of Lindane Medications
Lindane has been repeatedly and extensively reviewed by scientific and medical experts working with the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) since it was first introduced into healthcare more than 50 years ago. In each instance, expert reviewers have determined that approved medical uses of pharmaceutical-grade lindane do not pose a significant risk to public health or safety. Both the FDA and the EPA emphasize that the majority of safety concerns relating to the medical use of lindane medications have been the result of product misuse. Important changes in prescription labeling and medication packaging have substantially minimized this risk while protecting the public from the health consequences of scabies and lice. (See 2006 EPA RED on Agricultural Lindane)
Repeatedly the FDA has concluded that lindane medications have benefits that outweigh risks when used appropriately
Lindane medications have been monitored for safety since 1951
Click the different points on the timeline below to view regulatory determinations of lindane medications by subject matter experts working with the FDA and the EPA. The most recent review by the FDA in 2012 can be found at Medical & Scientific Opinions.
1951—Lindane FDA-approved for scabies and lice1
Results of the first clinical research study on the use of lindane for treating scabies and lice are published in 19482
- 1972—FDA Special Review concludes lindane is safe and effective3
1977—FDA Advisory Committee reaffirms lindane is safe and effective when used as directed3,4
The FDA Dermatologic Drugs Advisory Committee includes scientific and medical experts from dermatology and epidemiology (the study of diseases in human populations), plus a consumer-nominated representative.3
1977—FDA updates label for safety3,4
FDA Advisory Committee recommends that the lindane margin of safety would be enhanced by including stronger warnings; language is subsequently added to the product label highlighting special caution with use in infants, children and pregnant women.3,4
1983—FDA reaffirms need for lindane medications and updates label for safety3,4
The FDA Advisory Committee determines that lindane is safe when used according to the product labeling and that lindane remains an important treatment option for patients with no alternatives.4
1984—FDA Advisory Committee conducts in-depth review of lindane and updates label for safety3,4
FDA experts discuss the role of prescription topical medications for skin infections, and recommend that lindane products remain on the market.3
- 1985—FDA Advisory Committee conducts in-depth review of lindane and updates label for safety3,4
- 1989—FDA updates label for safety3
1991—EPA sets maximum lindane levels considered safe in drinking water at 0.2 parts per billion (ppb)5
EPA bases its 1991 determination for drinking water on a “reference dose” (RfD) for lindane of 0.3 µg/kg/day (micrograms per kilogram per day)—a dose considered to be safe in animals and humans.5
1992—Label updated for safety3
The FDA Advisory Committee updates the warnings in lindane product labeling to specifically highlight risks related to product misuse (i.e., excess dosage, overexposure, frequent reapplications, and accidental and intentional ingestion of lindane).3
1993—FDA concludes the majority of serious adverse events are related to lindane misuse3,4
FDA Advisory Committee unanimously concludes in 1993 that lindane remains safe and effective for treatment of both lice and scabies if used as directed.3
1995—FDA rejects 4 Citizen’s Petitions to ban lindane; label updated, repositioning lindane for second-line use4
Lindane is approved for use in patients with scabies and lice who have failed or cannot tolerate first-line medications.
2002—FDA safety review again concludes the majority of serious events are related to lindane misuse6
FDA conclusions are based on a review of the Adverse Event Reporting System (AERS) database, “a collection of spontaneous, voluntarily-submitted reports of adverse events associated with drug products submitted by consumers, healthcare professionals, manufacturers, and others.” 6
2002—EPA concludes as part of its reregistration eligibility decision for lindane that medical uses of pharmaceutical-grade lindane do not pose significant health or environmental safety risks when used properly7,8
Based on an updated risk assessment for lindane, EPA raises the “reference dose” (RfD) of lindane—the dose not expected to cause harmful effects in animals or humans—from 0.3 to 4.7 µg/kg/day (micrograms per kilogram per day).5
2003—FDA provides for single-use packaging in 2 oz. bottles, patient medication guide, and boxed label warning on risks and proper use1,9
FDA finds that smaller package sizes will minimize the potential for patients to apply excessive amounts or to incorrectly reapply lindane products.1 By law, the new medication guide must be dispensed with each new prescription of lindane by pharmacists to educate patients on potential risks and appropriate use.9
2003—EPA finds that new safety data supports raising the amount of lindane allowed in drinking water from 0.2 ppb to 1.0 ppb; lindane water levels well below more stringent 0.2 ppb goal—change not implemented for this reason5
EPA decides that raising the allowable drinking water levels to 1.0 ppb would not provide meaningful cost savings for public water systems or their customers5
Please See Important Safety Information
- U.S. Food and Drug Administration (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.
- Roos TC, Alam M, Roos S, et al. Pharmacotherapy of ectoparasitic infections. Drugs. 2001;61(8):1067–1088.
- Woodcock, J. (Director, FDA Center for Drug Evaluation and Research). “Re: Docket No. 95P-0018/CP.” Correspondence to Jill A. Cashen, Cancer Prevention Coalition. May 13, 1997.
- U.S. Food and Drug Administration (FDA). Lindane Assessment Memorandum. Posted 2003. Available at: http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM110853.pdf.
- U.S. Environmental Protection Agency (EPA). Announcement of completion of EPA’s review of existing drinking water standards. Federal Register. 68(138): July 18, 2003.
- U.S. Food and Drug Administration (FDA). Lindane Post Marketing Safety Review. 2002. Available at: http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM110854.pdf.
- U.S. Environmental Protection Agency (EPA). Lindane Reregistration Eligibility Decision (RED). 2002. Available at: http://www.lindane.com/pdf/lindane_epa_2002.pdf.
- U.S. Environmental Protection Agency (EPA). Revised Assessment of Risk from Use of Lindane for Treatment of Lice and Scabies. July 31, 2002. Available at: http://www.lindane.com/pdf/EPA-Revised_Assessment-2002-07-31.pdf.
- U.S. Food and Drug Administration (FDA). Lindane Assessment Memorandum. 2003. Available at: http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM110853.pdf.