Petition to Ban Lindane Lice Shampoo Rejected By FDA

Federal health regulators have rejected a long-standing call to ban the lice treatment Lindane, allowing the product to remain on the market despite its recall in other countries and recognized threats posed to children’s health and the water supply. 

The National Resources Defense Council (NRDC), an environmental policy organization, announced on November 27 that the FDA has refused to ban Lindane from pharmaceutical use.

Lindane is a neurotoxin used to treat lice and scabies, but has been banned in other countries around the world and by even some parts of the U.S. due to potentially lethal side effects.

In addition to its use against lice, Lindane has been used as a pesticide since 1942 and was originally used to treat crops. However, it has been linked to toxic health side effects, particularly for the elderly and children, the latter of whom are most likely to be subjected to treatment by lindane-based lice shampoos and lotions.

Because of risks to the liver and kidneys and the environment, Lindane was banned from international agricultural use by the Stockholm Convention on Persisten Organic Pollutants in 2009. The treaty also called for the phase-out of Lindane as a second-line treatment for lice by 2014.

The NRDC sent a petition (PDF) to the FDA calling for a Lindane ban in June 2010.

“Lindane is known to cause serious human health effects, and FDA”s continued approval of lindane as a treatment for head lice and scabies not only places patients’ health at risk, but also violates federal law,” the NRDC wrote.

California has banned all uses of Lindane. The U.S. Environmental Protection Agency (EPA) cancelled the registrations for all Lindane pesticides, which stopped agricultural use nationwide, but did not affect pharmaceutical use.

It is no longer produced in the U.S. or in most countries that used to produce it. Currently, Lindane is only manufactured in Russia and India.

Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, responded to the petition, telling the NRDC that its petition provided no new information that would require a Lindane recall, and pointed out that the U.S. is not bound by the Stockholm Convention.

In fact, the President George W. Bush signed the Stockholm Convention in 2001, but Congress has failed to ratify it.

The FDA itself has regulated Lindane to a second-line treatment for lice under a Risk Evaluation Management Strategy (REMS), reserved for drugs and substances known to be a danger that have to be used with extreme care.

Even the FDA acknowledges the risks of using Lindane are sometimes high. “Patients are at risk for serious neurologic adverse events, and even death, particularly with early retreatment,” the agency stated in a 2009 Lindane public health advisory. “It is not known how soon after administering one dose of Lindane that a second dose can be safely administered.”