FDA Action Shows Grave Dangers Of Lindane Lice Treatment, Says National Pediculosis Association
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BOSTON, April 10, 1996 -- The National Pediculosis Association (NPA) today applauded the FDA's new recommended labeling changes for childhood lice treatments containing the pesticide lindane, a chemical identified as a hazardous substance by the Agency for Toxic Substances and Disease Registry of the U.S. Department of Health and Health and Human Services. At the same time, the NPA continues to warn parents and pediatricians of the "grave" implications of using any lindane-based products -- citing a growing body of evidence that the product can cause serious and sometimes fatal conditions.
"In its statement, the FDA advised that lindane be a treatment of last resort -- its own acknowledgment that this pesticide can carry serious risks," said NPA President Deborah Altschuler. "The reports we have been receiving indicate that these risks are more widespread than previously acknowledged, and that in certain cases, the adverse effects in lindane outweigh the risks of having lice. In particular, pregnant or nursing women should never be exposed to any of the lice pesticides, even as a last resort."
There are as many as 12 million cases of lice within the United States each year, with most involving children. Over $100 million are spent on lice treatment products on an annual basis.
The FDA has recommended labeling changes that encourage lindane's use only for patients who have either failed to respond to adequate doses, or are intolerant of, other approved therapies."Altschuler noted two of the problems that remain despite this recommendation:
Since May 1994, when it opened its National Registry for reporting adverse events related to lice and scabies treatment products, the NPA has received and submitted over 500 adverse event reports to the FDA's Med Watch Program -- approximately two-thirds of which were related to the use of lindane. The reports include seizures, behavioral changes, neuromuscular complaints, attention deficit disorders, chronic skin eruptions, cancer and death.
The NPA's mission is to protect children from the misuse of potentially harmful lice and scabies pesticidal treatments. Incorporated in 1983, the NPA is the only non-profit health education agency established to build awareness of head lice prevention and to help standardize head lice control policies nationwide. As part of its mission, the NPA utilizes the head lice issue as an early opportunity to teach children responsible personal health behaviors. The NPA is currently sponsoring a treatment study to investigate possible lice resistance. The study is being conducted at the Harvard School of Public Health.
"Moreover, physicians are not attunded to parental misuse, and are not looking for possible symptoms following lindane treatment, be they initially subtle or pronounced," she added. In previous testimony before the FDA on this issue, the NPA urged that "endemic status of lice among America's children dictates that lice treatment exposure be part of routine history taking."
To report product treatment failures, community outbreaks of lice or scabies, or adverse reactions to products, individuals can call the NPA registry at 800-446-4NPA. NPA offers suggestions for those experiencing head lice treatment failure. To receive these suggestions and/or a lice or scabies brochure, send a self-addressed stamped envelope along with your request to NPA, P.D. Box 610189, Newton, MA 02161-0189. NPA also offers recorded educational messages on lice and scabies available 24 hours a day by calling 617-449-6487.
CONTACT: Dawn Ringel of Cumpert Communications, 617-444-5536 or home: 617-449-4167,or Deborah Z. Altschuler, ext. 101, or Linda Menditto, ext. 108, both of NPA, 617-449-6487