Citizen Petition Seeking to Ban the Use of Lindane (gamma-hexachlorocyclohexane) as Treatment for Lice and Scabies

17 January 1995

David A. Kessler, M.D.

Commissioner

Food and Drug Administration, Room 1-23

12420 Parklawn Drive

Rockville, MD 20857

The undersigned submits on behalf of the Cancer Prevention Coalition, Inc. (CPC), Samuel S. Epstein, M.D., Chair, Quentin Young, M.D., and Peter Orris, M.D, and on behalf of the Center for Constitutional Rights, Michael Deutsch, Esq. This citizen petition is based on recent scientific information on risks of brain cancer in children resulting from the use of lindane shampoo, other evidence of carcinogenicity, and evidence of hematotoxicity and neurotoxicity.

The undersigned submits this petition under 21 U.S.C. 321(n), 361, 362, and 371(a); and 21 CFR740.1, 740.2 of 21 CFR 10.30 of the Federal Food, Drug, and Cosmetic Act to request the Commissioner of the Food and Drug Administration (FDA) to immediately ban the use of lindane as a treatment for lice and scabies.

A. Agency Action Requested

This petition requests that FDA take the following action:

(1) Immediately ban the use of lindane as a treatment for lice and scabies.

(2) Pursuant to 21 CFR 10.30 (h) (2), a hearing at which time we can present our scientific evidence.

B. Statement of Grounds

Lice and scabies are endemic among the population. An estimated six million Americans, mainly children, are infested with lice each year. Most children are treated with pesticide-containing products marketed as shampoo. Lindane (gamma-hexachlorocyclohexane) is one of the most widely prescribed treatments for lice and scabies.

In a recent case-control study, Davis et al. reported a statistically significant increase of brain cancer in children following treatment with lindane shampoo:

…use of Kwell® [lindane] was significantly associated with childhood brain cancer in comparison to friend controls (OR-4.6; 95% CI -1.0-21.3).1

These findings are of particular significance in relation to the striking increase, 38%, in the incidence of brain and nervous system cancers in children from 1973 to 1991.2

Further evidence on carcinogenicity is provided by two epidemiological studies by the National Cancer Institute.3,4 Statistically significant increases, up to six-fold, in the incidence of non-Hodgkin’s lymphoma were reported in farmers exposed to lindane.

In addition to these epidemiological data, a series of case reports on blood disorders, including aplastic anemia, with case fatality rates of some 50%, and leukemia have appeared in the literature over the last three decades.5,6 Of related interest is recent evidence on the high toxicity of lindane to human red blood stem cells.7

These epidemiological data are further supported by experimental evidence on the carcinogenicity of lindane. Lindane is classified as Group 2B by the International Agency for Research on Cancer,8 and as 2B/C by the Environmental Protection Agency. The EPA has restricted lindane’s use as an agricultural pesticide.9 Agricultural and other uses of lindane and other isomers of hexachlorocyclohexane have been severely restricted or banned by other countries.10

The neurotoxic effects of lindane are well known. A 1976 FDA alert was issued to warn physicians of such risks.11 Numerous case reports have documented seizures and brain damage following lindane exposure.12 Recent studies have emphasized that recommended dosages of lindane may cause seizures:

Therefore, given the extremely narrow range of safety of this drug and the risk imposed by the kindling effect, which potentiates convulsive seizures, and that this potentiation may be carried on for a considerable period of time, there is no good reason to use lindane in children or adults when other perfectly effective, safer pediculides are available.13

Lindane is readily absorbed through the skin.14 After topical application to the adult skin without washing for 24 hours, almost 10% can be recovered from urine.15 Absorption is further increased when lindane is administered in warm water or followed by oil-based hair care preparations.

C. Claim for Categorical Exclusion

A claim for categorical exclusion is asserted pursuant to 21 CFR25.24 (a) (11).

D. Certification

The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition.

This petition is submitted by:

Jill A. Cashen

Samuel S. Epstein, M.D.

Cancer Prevention Coalition

520 North Michigan Avenue, Suite 410

Chicago, Illinois 60611

Phone:312-467-0600

Fax: 312-467-0599

Quentin Young, M.D.

Peter Orris, M.D.

Council to the Cancer Prevention Coalition:

Michael E. Deutsch, Esq.

Legal Director

Center for Constitutional Rights

666 Broadway

New York, NY 10012

212-614-6427

References:

1. J.R. Davis, R.C. Brownson, R. Garcia, B.J. Beniz, and A. Turner. “Family Pesticide Use and Childhood Brain Cancer,” Arch. Environ. Contam. Toxicol. 24:87-92, 1993.

2. L.A.G. Reis, B.A. Miller, B.F. Hankey, C.L. Kosary A. Harras, B.K. Edwards, Eds. SEER Cancer Statistics Review, 1973-1991: Tables and Graphs, National Cancer Institute, NIH Pub. No.94-2789:428, Bethesda, MD, 1994.

3. K.P. Cantor, A. Blair, G. Everett, R. Gibson, L.F. Burmeister, L.M. Brown, L. Schuman, and F.R. Dick. “Pesticides and other agricultural risk factors for non-Hodgkin’s lymphoma among men in Iowa and Minnesota,” Cancer Res. 52: 2447-2455, 1992.

4. A. Blair, O. Axelson, C. Franklin, O.E. Paynter, N. Pearce, D. Stevenson, J.E. Trosko, H. Vainio, G. Williams, J. Woods, and S.H. Zahm. “Carcinogenic Effects of Pesticides,” in: The Effects of Pesticides on Human Health, S.R. Baker and C.F. Wilkinson, Eds. Pp. 201-260, Princeton Scientific Publishing Co., Princeton, NJ, 1990.

5. American Medical Association Council on Drugs. “Registry on blood dyscrasias: Report to the AMA Council,” JAMA 148-150, 1962.

6. Agency for Toxic Substances and Disease Registry. “Toxicological profile for alpha-, beta-, gamma- and delta- hexachlorocyclohexane (update),” U.S. Department of Health and Human Services, Pub. No. TP93/09:43, May 1994.

7. D. Parent-Massin, D. Thouvenot, B. Rio, and C. Riche. “Lindane hemotoxicity confirmed by in vitro tests on human and rat progenitors,” Hunan Exp. Toxicol. 13:103-106, 1994.

8. International Agency for Research on Cancer. “Hexachlorocyclohexanes,” Monographs on the Evaluation of Carcinogenic Risks to Humans: Overall Evaluations of Carcinogenicity Supplement 7:220-222, 1987.

9. Agency for Toxic Substances and Disease Registry p. 142-149.

10. United Nations. “Consolidated list of products whose consumption and/or sale have been banned, withdrawn, severely restricted or not approved by governments,” 4th Edition, p.238-240, New York, 1991

11. Food and Drug Administration. “Gamma Benzene Hexachloride (Kwell and Other Products) Alert” FDA Drug Bulletin 28, June-July 1976.

12. M. Wheeler. “Gamma Benzene Hexachloride (Kwell) Poisoning in a Child,” Western J. Med. 127:518-521, 1977.

13. L.M. Solomon, D.P West, and J.F. Fitzloff. “Lindane” letter, Arch. Dermtol. 126:248, 1990.

14. Agency for Toxic Substances and Disease Registry p.51, 1994.

15. Food and Drug Administration, 1976.


FDA Responses (May 13, 1997)

Because lindane is safe and effective if used as directed, the agency denies your request (1) to ban the use of lindane as a treatment for lice and scabies, and (2) to conduct a hearing under 21 CFR 10.30(h)(2) so that you can present your scientific evidence.