Lindane Facts: The Truth About Lindane

• What Is Lindane?
  • Healthcare vs. Agricultural Uses
  • Regulatory History
  • The Need for Second-line Medications
• Understanding Scabies and Lice
  • Infectious Disease Perspective
  • Incidence and Health Risks
  • Diagnosis
  • Treatment Options
  • Resistance
• Safety Considerations for Lindane
  • Adverse Events
  • Misuse Potential
  • Cancer-Causing Potential
  • Drinking Water Contamination
• Lindane Product Advancements
  • Packaging
  • Prescription Product Labeling
  • Patient Education
  • Ongoing Research Investments
• Checking Lindane Facts
• Resources on Lindane

Understanding Scabies and Lice

Treatment Options for Scabies and Lice

Topical medications, including prescription and over-the-counter remedies that are applied to the skin, are considered the mainstay of scabies and lice treatment. Unfortunately, none are 100% effective and some patients are intolerant of some of these medications because of allergies or adverse side effects. Moreover, treatment-resistant forms of scabies and lice have increased in recent years, further compromising the effectiveness of available medications. Manual removal of head lice and their nits with special combs is appropriate in select situations, but is labor intensive and not a preferred method.1,2 As such, a range of first- and second-line treatment options is necessary for effective disease control and individualized patient care.

FDA-approved therapies for scabies are relatively limited

Medications that are currently approved by the Food and Drug Administration (FDA) for the topical treatment of scabies include:

• Permethrin
• Crotamiton
• Lindane

An oral medication called ivermectin is also used for the management of scabies, but is not FDA-approved for this indication.3 Additional information, including links to respective product labels, can be found in the table below.

Healthcare providers have few effective treatment options for managing scabies.

Medications Used To Treat Scabies
Medication (brand name)	Availability	CDC Position*	FDA Position
Permethrin 5% cream4,5 (Elimite®, Acticin®)	Prescription only	Recommended regimen	Approved first line
Crotamiton 10% cream or lotion6 (Eurax®)	Prescription only	None	Approved first line
Lindane 1% lotion7 (generic only)	Prescription only	Alternative regimen	Approved second line†
Ivermectin oral tablets8 (Stromectol®)	Prescription only	Recommended regimen—off-label use	Not approved for scabies

* As listed in 2006 Centers for Disease Control and Prevention's (CDC's) Sexually Transmitted Disease Treatment Guidelines.9
†Lindane is indicated for patients who have failed or cannot tolerate first-line medications.

Treatment failure with scabies medications occurs for many reasons:10

• Resistance (demonstrated for all scabicides)
• Improper application (e.g., only applied to selected areas)
• Inadequate application (e.g., dilution, lack of compliance with regimen)
• Reinfestation (e.g., failure to treat close social contacts or launder clothes/bedding)

Lice pose an ongoing treatment challenge

Lice infestation remains a significant public health problem in the U.S. despite the available treatments. Medications commonly used to treat lice include:

• Pyrethrin
• Permethrin
• Lindane
• Malathion

An oral medication called ivermectin is also used to treat lice but is not FDA approved for this indication.8,11 Additional information, including links to respective product information, can be found in the table below.

Medications Used to Treat Head Lice and Pubic (crab) Lice
Medication (brand name)	Availability	CDC position—pubic lice only*	FDA position
Pyrethrins [0.33%] with piperonyl butoxide [4%]12 (Rid®)	Over-the-counter	Recommended regimen	Conforms to FDA over-the-counter drug monograph 21CFR 358.610
Permethrin 1% crème rinse13 (Nix®)	Over-the-counter	Recommended regimen	Approved for first-line treatment of head lice only
Malathion 0.5%14 (Ovide®)	Prescription only	Alternative regimen	Approved for first-line treatment of head lice only
Lindane 1% shampoo15 (generic only)	Prescription only	Second-line regimen	Approved for second-line† treatment of both head lice and pubic (crab) lice
Ivermectin oral tablets8 (Stromectol®)	Prescription only	Alternative regimen—off-label use	Not approved for lice

* As listed in 2006 Centers for Disease Control and Prevention's (CDC's) Sexually Transmitted Disease Treatment Guidelines.9
†Lindane is indicated for patients who have failed or cannot tolerate first-line medications.

Treatment failure with lice medications can occur for many reasons:16

• Resistance (a concern with all available lice medications)
• Poor compliance with treatment and medication regimens
• Application to wet hair (i.e., dilutes medication and causes lice to shut down their breathing, further limiting their exposure to medication)
• Reinfestation (e.g., re-exposure to lice or failure to treat personal social contacts)

Manual removal (“wet combing”) of nits is not a preferred method for treating lice

• Manual removal is relatively labor intensive and involves the combing of wet hair (“wet combing”) with a special comb for 15 to 30 minutes or more every 3 to 4 days for several weeks17 (See: Fact Checker)
• Moreover, evidence for the effectiveness of wet combing in controlling lice infestations is generally lacking18
• The CDC and The American Academy of Pediatrics (AAP) designate pediculicidal medications as the preferred approach over wet combing for the treatment of head lice1,2
• Nonetheless, wet combing is an appropriate alternative when the use of medications is not appropriate (e.g., lindane should be used with caution in infants, children, the elderly, pregnant or lactating women, individuals with other skin conditions and in those who weigh <110 lbs.)

Please See Important Safety Information on Lindane

References:

1. Frankowski BL, Weiner LB. Head lice: Guidance for the clinician in rendering pediatric care. Pediatrics. 2002;110;638–643.
2. U.S. Centers for Disease Control and Prevention (CDC). Parasitic Disease Information: Head Lice Fact Sheet. 2005. Available at: http://www.cdc.gov/ncidod/dpd/parasites/lice/factsht_head_lice_treating.htm.
3. Wendel K, Rompalo A. Scabies and pediculosis pubis: an update of treatment regimens and general review. Clin Infect Dis. 2002;35:S146–S151.
4. Acticin® (permethrin topical) drug information. Available at: http://www.drugs.com/mtm/a/acticin.html.
5. Elimite® (permethrin cream 5%) drug information. Available at: http://www.drugs.com/PDR/Elimite_Cream.html.
6. Eurax® (crotamiton cream and lotion) prescribing information. Available at: http://www.fda.gov/medwatch/SAFETY/2003/03Jun_PI/Eurax_PI.pdf.
7. Lindane lotion, USP, 1% prescribing information. Updated March 28, 2003. Available at: http://www.fda.gov/cder/foi/label/2003/006309lotionlbl.pdf.
8. Stromectol® (ivermectin tablets) prescribing information. Available at: http://www.merck.com/product/usa/pi_circulars/s/stromectol/stromectol_pi.pdf.
9. U.S. Centers for Disease Control and Prevention (CDC). Ectoparasitic infections. Sexually transmitted diseases treatment guidelines, 2006. MMWR Recomm Rep. 2006, August 10;55 (No. RR-11):79-80. Web version available at: http://www.cdc.gov/std/treatment/.
10. Karthikeyan K. Treatment of scabies: newer perspectives. Postgrad Med J. 2005;81:7–11.
11. Habif TP. Pediculosis. In: Clinical Dermatology, 4th edition. New York: Mosby; 2004:506–510.
12. Rid® Shampoo (pyrethrum extract and piperonyl butoxide) drug information. Available at: http://www.drugs.com/pdr/maximum_strength_rid_shampoo.html.
13. Nix® Crème Rinse (permethrin 1%) drug information. Available at: http://www.drugs.com/PDR/Nix_Creme_Rinse.html.
14. Ovide® (malathion lotion) prescribing information. Available at: http://www.ovide4headlice.com/Headlice_OVIDEmalathionLotion.html.
15. Lindane shampoo, USP, 1% prescribing information. Updated March 28, 2003. Available at: http://www.fda.gov/cder/foi/label/2003/006309shampoolbl.pdf.
16. Witkowski JA, Parish LC. Pediculosis and resistance: the perennial problem. Clin Dermatol. 2002;20(1):87–92.
17. Roberts RJ. Clinical practice. Head lice. N Engl J Med. 2002;346(21):1645–50.
18. Downs AM. Managing head lice in an era of increasing resistance to insecticides. Am J Clin Dermatol. 2004;5(3):169–177.

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