Lindane Product Advancements
Prescription Packaging of Lindane
Both 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 (e.g., swallowing large quantities, excess application).1,2 To minimize this risk and enhance product safety, lindane lotions and shampoos manufactured in the U.S. have been restricted to single-use, 2 oz. bottle packaging since 2003. Now, patients filling their lindane prescriptions receive just enough medication for a single treatment.1
Single-use 2 oz. packaging dramatically minimizes risk for misuse of lindane medications
- Minimizes risk of excess application or reapplication of lindane
- Minimizes risk of accidental or intentional oral ingestion of large quantities of lindane
- Minimizes risk of use of leftover medication by persons other than the patient for whom lindane was prescribed (including others who may not actually be infected with scabies or lice)
|Regulatory status||Prescription only||O.T.C.*, no prescription required|
|Packaging||2 oz., single-use bottle only||Up to 17 oz. bottle; enough lindane for 8 or more treatments|
Non-U.S. lindane packaging increases misuse potential
The availability of U.S.-manufactured lindane medications eliminates the need for patients with no other treatment options to turn to foreign suppliers, through websites or alternative channels, for less-regulated lindane products, where the risk for misuse and serious side effects is much greater.
- For example, the large, 17 oz. bottle of lindane sold in Canada makes it easier for less-informed patients and caregivers to misuse lindane, and increases the risk of serious adverse events from accidental or intentional ingestion of large amounts of lindane
- Moreover, lindane is available without a prescription from Canadian sources and is easily purchased by patients who are not required to see a healthcare provider for proper diagnosis and counseling
- The FDA has recently warned Canadian drug importers about consistent misrepresentation of the safety of foreign drug products and failure to include important patient safety information7
Keeping lindane on the market in the U.S. as a prescription therapy regulated by the FDA protects the American public from the potential dangers discussed above.
Please See Important Safety Information on Lindane
- 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. Environmental Protection Agency (EPA). Lindane Reregistration Eligibility Decision (RED). 2002. Available at: http://www.lindane.com/pdf/lindane_epa_2002.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.
- 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.
- Lindane Canadian package insert: Lindane Shampoo and Lotion. Pharmascience, Inc., Montréal, Canada.
- U.S. Food and Drug Administration (FDA). Warning letter to Discount Prescription from Canada. February 20, 2004. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm055367.pdf