When Chemical Warfare Against Lice Becomes Chemical Warfare Against Kids

The National Pediculosis Association says FDA's latest warnings fail. The FDA’s warning, although an important action, is ambiguous and fails to protect the public. Their black box (representing the most stringent of warnings for a product) is negated by the recommendation to use Lindane as a second-line therapy or after other products have failed. The NPA urges FDA to ban Lindane.

April 1, 2003 - On March 28, 2003, the U.S. Food and Drug Administration (FDA) announced new warnings on prescriptions for children containing the chemical Lindane (see Lindane.org), a topical formulation used to treat head lice and scabies. The warning emphasizes that these products should be used “with caution on patients who weigh less than about 110 pounds.”

This comes after the FDA’s earliest warning in 1976 of seizures associated with Lindane and its more recent admonition in 1996 warning consumers of severe skin inflammation. At that time, the label was already required to warn of potential neurological side effects.

Lindane, a bio-accumulative and toxic chemical was used as a chemical weapon during World War I. It is used for medical research to induce seizures in rats and the Agency for Toxic Substances and Disease Registry has prioritized Lindane as 33rd on its list of 275 hazardous substances.

It is a known risk to humans and, when utilized as a shampoo or lotion treatment for lice or scabies, is documented as a serious contaminant of water via residential use of public sewers. A single treatment for head lice or scabies with Lindane pollutes 6 million gallons of water.

The state of California banned Lindane totally in 2001 following documentation of Lindane pollution in LA County’s water supply and investigations continue regarding pollution from other lice treatment pesticides including Permethrin and Malathion, according to Ann Heil, Senior Engineer for the Sanitation District of Los Angeles County.

The National Pediculosis Association (NPA), Consumers Union and Ralph Nader’s Public Citizen group filed petitions with the FDA to ban Lindane and testified before the FDA to this effect in 1983, 1984, 1985, 1993, and 1995. Many other health and environmental organizations such as the National Resources Defense Council have joined the effort that continues to this day.

The NPA, a non-profit organization incorporated in 1983 to protect children and their families from misuse and abuse of pediculicides and scabicides, submitted several hundred Lindane and other pesticide treatment related adverse event reports to MedWatch (the FDA’s Safety Information and Adverse Event Reporting Program) in 1995.

This prompted the FDA’s 1996 warning about misuse. However, reports to the NPA reflect that “normal” use of these products is misuse, making chemical treatments for head lice a constant and predictable health risk.

Opportunities for inappropriate use of over-the-counter and prescription treatments designed to kill lice or remove nits are common. Products with scientifically proven lice resistance continue to be vigorously marketed to the public and recommended through industry-driven guidelines such as those recently adopted by the American Academy of Pediatrics.

Over 95% of lice products currently available on the drug store shelf are known to be less than 100% effective at best, and, in many cases, totally ineffective given documented lice resistance.

At the expense of prudent prevention measures and safer choices, parents are regrettably directed to seek prescription pesticides such as Lindane or Malathion as a follow-up remedy to ineffective over-the-counter pesticide shampoos, cremes and lotions.

To avoid potential harm, the NPA alerts parents via its website – www.headlice.org – that "Pesticide shampoos, cremes and lotions are not to be used repeatedly, in conjunction with, or as a follow-up to other chemical formulations."

The alert also states: "New industry-driven guidelines direct parents and health professionals to over-the-counter pesticide products already documented to be less than 100% effective at best, or with documented lice resistance to them. When these treatments fail, the guidelines unfortunately recommend the prescription pesticides Malathion and Lindane. There are health risks inherent with the use of pesticides on children and these risks increase dramatically when you follow one chemical treatment with another."

The NPA advises parents to "Discontinue the use of any treatment at the earliest sign of failure and to avoid using other chemicals. Manual removal is the best option whenever possible, especially when treatment products have failed."

The NPA has, since its inception, informed parents and health professionals about the risks of pesticides for lice and scabies with warnings to avoid Lindane entirely. The NPA emphasizes education in advance of outbreaks, and promotes routine screening, early detection and manual removal by combing as the safe, non-chemical alternative for lice. The NPA accomplishes and supports its mission of education, research and prevention by providing screening and combing tools and educational resources.

The FDA’s warning, although an important action, is ambiguous and fails to protect the public. Their black box (representing the most stringent of warnings for a product) is negated by the recommendation to use Lindane as a second-line therapy or after other products have failed.

This ignores the cumulative and unpredictable combined effects of exposures to numerous other pesticides for lice and renders children more susceptible to harm from Lindane’s potentially adverse effects. Such an approach is illogical and makes for double jeopardy.

We cannot expect, nor can we hope, to successfully control Pediculosis and protect children's health by reliance on unsafe, ineffective treatments or by replacing one poison with another.

Lindane’s continued availability for use on children and their families in spite of what is known about the hazards of this chemical, and allowing products with documented lice resistance to remain available to consumers, contradicts FDA’s mandate to provide for the safety of the public.