Public Safety Considerations for Lindane
Misuse Potential of Lindane Medications
The Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) agree that lindane medications are safe when used properly, and that the majority of serious adverse events have resulted from product misuse.1,2 (See Regulatory Viewpoints on lindane)
- Excess or prolonged application
- Intentional or accidental oral ingestion
- Inappropriate patient selection
Many of the factors related to lindane misuse are no longer relevant
Prior to 2003, lindane medications were available in bottles containing 16 oz. of lindane—enough medication for 8 treatment courses. This packaging, now obsolete in the U.S., made it easier for less-informed patients and caregivers to misuse lindane prescription therapies, and increased the risk of harmful effects with oral ingestion.
Today, lindane medications are limited to single-use, 2 oz. bottles.5,6 This packaging change has dramatically reduced the risk for excess application, reapplication, and ingestion of large quantities of lindane. (See Lindane Product Advancements)
Important actions have dramatically reduced the risk of lindane misuse
The FDA continues to recognize the medical need to keep lindane on the U.S. market for the second-line management of scabies and lice. The FDA also recognizes the risks associated with lindane misuse and has taken action working with the U.S. manufacturer—Morton Grove Pharmaceuticals, Inc.—to implement a number of important changes that have dramatically reduced this risk.3
- Actions Implemented in 2003 to Prevent Lindane Misuse
- Public health advisory: Issued by the FDA on the risks and proper use of lindane medications3 (See FDA Information on Lindane)
- Single-use packaging: 16 oz. bottles are no longer allowed; dosages are limited to single-use, 2 oz. bottles5,6
- Boxed warnings: Updated prescription labeling for healthcare professionals, highlighting serious risks and essential information on appropriate patient selection (e.g., patients must weigh at least 110 lbs.)3,5,6
- Patient-friendly medication guide: Required by law to be dispensed with each lindane prescription by pharmacists to educate patients and caregivers on potential risks, proper use, and contraindications (e.g., use in newborn infants)7–9
Please See Important Safety Information on Lindane
- 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). Lindane Reregistration Eligibility Decision (RED). 2002. Available at: http://www.lindane.com/pdf/lindane_epa_2002.pdf.
- 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.
- U.S. Food and Drug Administration (FDA). Lindane Postmarketing Safety Review. 2002. Available at: http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM110854.pdf.
- Lindane lotion, USP, 1% prescribing information. Updated March 28, 2003. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/006309lotionlbl.pdf.
- Lindane shampoo, USP, 1% prescribing information. Updated March 28, 2003. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/006309shampoolbl.pdf.
- Medication Guide Lindane Lotion USP, 1%. Updated March 28, 2003. Available at: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM133687.pdf.
- Medication Guide Lindane Shampoo USP, 1%. Updated March 28, 2003. Available at: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM133688.pdf.
- U.S. Food and Drug Administration (FDA). Center for Drug Evaluation and Research (CDER) Report to the Nation: 2003. Available at: http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/WhatWeDo/UCM078975.pdf.