FDA May Ban Lice Shampoo for Children

FDA May Ban Lice Shampoo for Children

June 5th, 2012 // 12:12 pm @ jmpickett

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In a move that casts a spotlight on a little-known controversy, a Massachusetts congressman has asked the FDA to halt the use of an insecticide in pharmaceutical treatments for head lice in children. Known commercially as Lindane, the chemical has been widely used as an agricultural tool around the world, but is also a key component in a topical lotion and shampoo that are approved by the FDA for combating lice and scabies, although only as a second-line treatment.

Lindane, however, is a neurotoxin that can affect the liver and kidney, and infants and children may be more susceptible to potential adverse effects than adults, which was noted by the US Department of Health & Human Services Agency for Toxic Substances and Disease Registry (see this). The potential adverse effects prompted the Stockholm Convention to ban Lindane production and agricultural use three years ago (look here). The package inserts for the lotion and shampoo both list the possibility of seizures and deaths (see this and this).

“Despite these actions and the known dangers that Lindane poses to human health, the FDA continues to allow the use of this insecticide as a treatment for head lice in children,” Ed Markey, the Massachusetts Democrat, wrote in a May 31 letter to FDA commish Margaret Hamburg. He also notes parents may be inclined to overuse Lindance “in their zeal” to eradicate lice and scabies, which may increase resistance, ineffectiveness, exposure and a likelihood of adverse events.

He also noted that ongoing pharmaceutical use can contaminate water supplies. Five years ago, the US Environment Protection Agency cancelled registrations of all remaining pesticide products containing Lindane, but this has no effect on pharmaceutical use (read here). And a decade ago, California instituted a ban on pharmaceutical use of Lindane over concerns about water quality.

The results of California ban were favorable, at least according to a 2008 study in Environmental Health Perspectives, which found the move was associated with a reduction in reported unintentional exposures and did not adversely affect head lice and scabies treatment. “This ban serves as a model for governing bodies considering limits on the use of Lindane or other pharmaceuticals,” the authors concluded (see here).

“Given the scientific evidence on the toxicity of Lindane, its ineffectiveness as a lice and scabies treatment and the ability of this chemical to enter into US drinking water supplies despite its removal as a viable pesticide by the EPA, there is simply no basis for FDA’s decision to continue to allow the use of this substance for head lice and scabies treatment,” Markey wrote to the FDA. He asks whether the FDA has assessed harm to children, among other things (here is his letter).

However, the Stockholm ban includes a specific exemption allowing the chemical to continue to be used as a second-line pharmaceutical treatment for lice and scabies until 2014 (look here). Moreover, the US signed – but did not ratify – the Stockholm Convention on Persistent Organic Pollutants treaty, which means the US is not obligated to halt pharmaceutical usage.

This is not the first time the FDA has been asked to halt Lindane usage. Two years ago, the National Resources Defense Council and nine other groups petitioned the agency to ban Lindane (see the petition). In a letter sent last year to the NRDC, Jane Axelrad, associate director for policy at the FDA’s Center for Drug Evaluation and Research, wrote that the “FDA has been unable to reach a decision on your petition because it raises complex issues requiring extensive review and analysis by agency officials” (read the letter). An FDA spokeswoman wrote us to say the agency will respond to Markey, but offered no further comment.

The shampoo and lotion are sold in the US by Morton Grove Pharmaceuticals, which is owned by India’s Wockhardt. We asked the drugmaker for comment and will update you accordingly. When we reported on this issue last year, though, a Morton Grove exec maintained the drugmaker responded to the petition by maintaining the NDRC did not offer any new evidence about safety or effectiveness, especially when used as directed, and the specifics offered by the petition were purportedly reviewed in the past by the FDA.

Morton Grove also maintains labeling changes, which included a boxed warning in 2003, “enhanced” the benefit-risk profile of its treatments, and argued that agricultural and pharmaceutical exposure is decidedly different (read here and here). The drugmaker added that its Lindane website provides additional evidence supporting its contentions, along with testimonials from such people as former US Surgeon General Joycelyn Elders, who was one of several people to write the Michigan legislture three years ago to dissuade the state from banning the ingredient for pharmaceutical use (see this).

Whether the FDA takes any action in response to the congressman is unclear, but his missive adds ammunition to a small non-profit called the National Pediculosis Association, which has tussled with Morton Grove and government agencies over the insecticide for years. The NPA sells a comb that the Stockholm Convention on Persistent Organic Pollutants has listed as an alternative to pharmaceutical treatments containing Lindane. The FDA also cleared its comb for screening, detecting and removing head lice and their eggs (read here).

Several years ago, the drugmaker had charged NPA and another group with defamatory remarks about the safety and risks associated with its products, and that NPA “masquerades” as a health organization in order to sell its comb as a competitive item, which is called LiceMeister. Morton Grove, which sought $9.3 million in damages, also maintained that dangers from agricultural use “differ vastly” from short-term exposure as a topical salve (read the lawsuit). The suit was eventually settled and NPA was not required to admit liability or make any payments to Morton Grove.