When Chemical Warfare Against Lice Becomes Chemical Warfare Against
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
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
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
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
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
FDA’s Safety Information and Adverse Event Reporting Program) in
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
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.