Drug Profile

Lindane shampoo is available to treat head lice, while lindane cream and lotion are available to treat scabies. Outbreaks of head lice are commonplace in day care centers, schools, and nursing homes. Scabies is epidemic in nursing homes, homeless shelters, and among people with AIDS.

Treatment of lice or scabies with lindane is neither safe nor effective. Lindane is a pesticide of the organochlorine type, in the same group as DDT. Although the Environmental Protection Agency drastically cut the amount of lindane used in industry and agriculture, this toxin is still available. Workers exposed to lindane for a long time may eventually develop damage to their bone marrow, kidneys, liver, or reproductive organs.[1] Lindane is classified as a carcinogen. Even individuals who use lindane briefly for lice or scabies, as well as people whose work exposes them to lindane, can experience rashes, dizziness, or convulsions. Vomiting, muscle cramps, nervousness, unsteadiness, and fast heartbeat have also been reported.

Lindane is readily absorbed through the skin, particularly skin that is broken or has residues of oils on it. Crusts formed in Norwegian scabies increase absorption of lindane even more.[2] The Centers for Disease Control and Prevention recommends that bathing prior to applying lindane lotion be avoided, since toxicity is increased.[3] Lindane is contraindicated for premature infants. Children and the elderly are particularly prone to convulsions from lindane.[3] A further tragedy associated with lindane is misuse in infants and children. Lindane has been left on the skin 12 hours or longer without being washed off.[4] Such misuse has been fatal to some children.

At least 17 deaths associated with lindane use have been reported to the Food and Drug Administration (FDA), along with many more cases of seizures and other serious side effects. Most cases of serious side effects or death are associated with inappropriate use, although in some cases, severe reactions were reported after apparently normal use.

In addition to being dangerous, lindane also is relatively ineffective. A recent study used lindane to treat head lice collected in Florida. In the study, lindane killed only 2 percent of lice after 20 minutes and fewer than 20 percent after three hours. Furthermore, because the product’s instructions recommend applying it for 10 minutes, these results demonstrate that appropriate use of lindane would render the product totally ineffective when used according to the instructions. An exposure of 20 minutes to three hours, as in the study, would dramatically increase the risk of toxic effects.

A review of clinical tests of head lice products found that in the few well-designed studies that exist, lindane proved so ineffective that continued use could not be justified.[5] While no pediculicide is 100% effective, failure was at least eight times more likely with lindane than with permethrin (NIX). Lack of effectiveness encourages repeat applications. Prolonged use of lindane has lowered production of red blood cells. Concern also exists because some mites are now resistant to lindane; lice are suspected of developing resistance to lindane, as well as to alternative medications.

Public Citizen was one of the first consumer groups urging the FDA to ban lindane, first in 1983 and again in 1995. The 1995 petition came after analyzing 162 reports of adverse reactions, including convulsions in 50 people and six deaths.

The FDA’s response to the 1995 petitions was to restrict the drug’s use to second-line therapy only (i.e., using the drug in cases in which other treatments have failed or are not tolerated).

The Cancer Prevention Coalition also petitioned the FDA in 1995 to ban the chemical based on evidence that it caused cancer in animals along with reports of increased rates of brain cancer in children treated with lindane shampoos.

In March 2003, the FDA issued a public health advisory about lindane.[6] The agency announced that a black-box warning would be required on the professional product labeling of the drug. A black-box warning is the strongest type of warning that the FDA can require on a drug’s professional labeling. Also, pharmacists would be required to distribute a medication guide, written specifically for patients, with each lindane prescription. At this time, only drugs that pose serious public health concerns are required to be dispensed with a medication guide.

In 2006, the U.S. Environmental Protection Agency canceled registrations of all pesticide products containing lindane because they can remain in the environment and cause drinking water contamination. In 2009, more than 160 nations agreed to ban lindane’s use and production under the Stockholm Convention on Persistent Organic Pollutants.

Due in part to concerns about water quality, California banned pharmaceutical use of lindane in 2002. A study following the California ban found a noticeable decrease in drinking water contamination in the state. Researchers also noted a dramatic decline in poison control center calls related to accidental exposure to lindane during the same period.

The World Health Organization recommended against using lindane for scabies or lice as early as 1993, due to its toxic effects and ability to stay in the environment after use. As of 2009, the American Academy of Pediatrics no longer recommends lindane as a treatment for lice in children.

In November 2012, the Natural Resources Defense Council (NRDC) announced that the FDA had denied the group’s petition to ban lindane.

The NRDC petition, specifically citing the drug’s safety risks (particularly for young children) and lack of effectiveness, was the latest in a long series of efforts by consumer groups to ban lindane for medical use.