Public Safety Considerations for Lindane

Adverse Events

The safety of lindane medications is well established

The safety profile of lindane medications is well supported by clinical study data and postmarketing surveillance of adverse events reported to the Food and Drug Administration (FDA), the manufacturer and other healthcare providers during the 50+ years that lindane therapies have been prescribed. Indeed, the weight of scientific evidence shows that lindane medications are safe and well tolerated and that serious side effects are rare.1-5

For example, the results of a large postmarketing safety study of head lice treatments involving more than 34,000 patients and 37 local U.S. health departments documented a low rate of adverse events of 0.4% for patients treated with lindane.6 Importantly, no serious events were reported in this large safety study with the use of lindane shampoo or any of the other study treatments. Moreover, there was no difference in the number of “medically significant” events associated with lindane compared with permethrin (e.g., Nix®)— the most commonly used first-line treatment for lice. These findings are particularly meaningful given the large patient sampling and the ability of postmarketing analyses to detect rare and more serious adverse drug reactions that may not have been identified in more controlled research settings.

Most Common Side Effects Are Nonserious

The most commonly reported side effects with lindane medications are nonserious reactions of the skin, including:7-9

Itching
Burning
Dry skin
Rash

Other Reports: 10,11

Other reported adverse events include dizziness, headache, pain, paresthesia (tingling), hives, and alopecia (hair loss). However, the relationship of some of these effects to lindane therapy is unclear.

The FDA has repeatedly concluded that lindane medications are safe and effective when used as directed, and that they remain important treatment options for patients with scabies, head lice and pubic lice who have limited alternatives.1

Serious adverse events are rare

Serious adverse events with lindane medications, such as seizures are rare and have almost always resulted from product misuse (e.g., swallowing large quantities, prolonged or repeated application, or application to broken or abnormal skin).10,11 In the U.S., lindane medications are now limited to single-use 2 oz. bottles to minimize this risk. (See Lindane Product Advancements)

All medications are associated with risks, even with proper use

All medications are associated with some level of risk. This is true for lindane as well as all other medications used to treat scabies and lice, including permethrin, pyrethrin, malathion, crotamiton and ivermectin—all have been associated, in rare instance, with serious neurologic toxicity (e.g., seizure) and death.12,13 However, the FDA has determined that, like lindane, these medications are safe and effective and provide benefits to patients that outweigh the potential risks when they are used as directed.

FDA Assessment Memorandum: 1: “There are potential risks when using ALL of the approved medications for the treatment of scabies and lice”

This guiding principle is applied to all medications reviewed and approved by the FDA. The table below lists potential risks, however rare, for a variety of commonly used medications in different therapeutic classes—both prescription and over-the-counter (O.T.C.)—that provide significant health benefits to the public.

Serious risks reported for popular O.T.C. and prescription (Rx) medications14-19
Medication	FDA Status	Reported risks
Acetaminophen (e.g., Tylenol®)	O.T.C.	Liver failure
Aspirin (e.g., Bayer®)	O.T.C.	Bleeding ulcer Hemorrhagic stroke
Loratadine (e.g., Claritin®)	O.T.C.	Rapid heartbeat Muscle weakness
Fluoxetine (e.g., Prozac®)	Rx only	Seizures Suicidal tendency in adolescents and children
Atorvastatin (e.g., Lipitor®)	Rx only	Jaundice (liver damage) Acute kidney failure
Birth control pills (e.g., Tri-Norinyl®-28)	Rx only	Heart attack Breast cancer

Bayer® is a registered trademark of Bayer HealthCare LLC.
Claritin® is a registered trademark of Schering-Plough HealthCare Products Inc.
Prozac® is a registered trademark of Eli Lilly and Company.
Lipitor® is a registered trademark of Pfizer.
Tri-Norinyl®-28 is a registered trademark of Watson Pharmaceuticals, Inc.
Tylenol® is a registered trademark of McNeil Consumer Healthcare.

Proper use of lindane medications is an important aspect of safety

Counseling of patients, parents, and other caregivers on the proper application of lindane medications is essential for their safe use. Special attention should be given to the following:7,8

How much to apply
How long to leave it on
The need to avoid reapplication

Since 2003, it has been required by law that pharmacists dispense a medication guide with every lindane prescription to counsel patients on risks and proper use.20 (See Lindane Patient Education)

Lindane Medications Are Not Right For Everyone10,11

Lindane medications are second-line therapies and should only be used in patients who cannot tolerate or have failed first-line medications
Caution should be used in infants, children, the elderly, and people with other skin conditions that may increase the absorption of lindane (e.g., atopic dermatitis, psoriasis), and in those who weigh <110 lbs.
Lindane should never be used in premature infants or in people with a history of seizures

Please See Important Safety Information on Lindane

References:

U.S. Food and Drug Administration (FDA). Lindane Assessment Memorandum. Posted 2003. (Emphasis added) Available at: http://www.fda.gov/cder/drug/infopage/lindane/lindanememoassessment.pdf.
U.S. Food and Drug Administration (FDA). Lindane Post Marketing Safety Review. Posted 2003. Available at: http://www.fda.gov/cder/drug/infopage/lindane/lindaneaeredacted.pdf.
Walker GJA, Johnstone PW. Interventions for treating scabies. Cochrane Database Syst Rev. 2006;4: CD0000320.
Dodd CS. Interventions for treating lice. Cochrane Database Syst Rev. 2001;2: CD001165.
Data on file. Morton Grove Pharmaceuticals, Inc.
Andrews EB, Joseph MC, Magenheim MJ, et al. Postmarketing surveillance study permethrin crème rinse. Am J Public Health. 1992;82(6):857-861.
Medication Guide Lindane Lotion USP, 1%. Updated March 28, 2003. Available at: http://www.fda.gov/cder/drug/infopage/lindane/lindaneLotionGuide.htm.
Medication Guide Lindane Shampoo USP, 1%. Updated March 28, 2003. Available at: http://www.fda.gov/cder/drug/infopage/lindane/lindaneShampooGuide.htm.
U.S. Food and Drug Administration (FDA). Lindane Shampoo and Lindane Lotion Questions and Answers. Available at: http://www.fda.gov/cder/drug/infopage/lindane/lindaneQA.htm.
Lindane lotion, USP, 1% prescribing information. Updated March 28, 2003. Available at: http://www.fda.gov/cder/foi/label/2003/006309lotionlbl.pdf.
Lindane shampoo, USP, 1% prescribing information. Updated March 28, 2003. Available at: http://www.fda.gov/cder/foi/label/2003/006309shampoolbl.pdf.
Wendel K, Rompalo A. Scabies and pediculosis pubis: an update of treatment regimens and general review. Clin Infect Dis. 2002;35:S146-S151.
Pannell M, Gilbert JD, Gardiner J, et al. Death due to malathion poisoning. J Clin Forensic Med. 2001;8:156-159.
Bayer® Aspirin package insert, Bayer HealthCare LLC, Morristown, NJ; 2005.
Claritin® package insert, Schering-Plough HealthCare Products Inc., Kenilworth, NJ; 2005.
Lipitor® prescribing information, Pfizer, New York, NY; 2005.
Tri-Norinyl®-28 prescribing information, Watson Pharmaceuticals, Inc., Corona, CA; 2000.
Prozac® prescribing information, Eli Lilly and Company, Indianapolis, IN; 2005.
Tylenol® regular strength product labeling, McNeil Consumer Healthcare, a Division of McNeil PPC, Inc. 1998-2006. Available at: http://www.tylenol.com/product_detail.jhtml?id=tylenol/hdache/prod_reg.inc&prod=subpreg#Top.
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/cder/drug/infopage/lindane/lindanePHA.htm.