March 28, 2003

Public Citizen Criticizes FDA for Failing to Ban
Topical Lindane Products Used for Treating Scabies and Lice

WASHINGTON, D.C. – Public Citizen today criticized the U.S. Food and Drug Administration’s decision not to ban products containing Lindane, a prescription drug used to treat scabies and lice. Instead of ordering the drug off the market, the agency issued a public health advisory for topical formulations of Lindane lotion and Lindane shampoo.

The FDA has received reports of at least 17 deaths associated with the use of Lindane and numerous reports of neurologic adverse effects ranging from dizziness to seizures. These numbers likely represent only a fraction of patient injuries, because the FDA estimates that only one in ten serious adverse drug reactions is ever reported.

"The FDA’s decision to leave Lindane on the market is completely irresponsible and another example of the agency failing to put public safety first," said Sidney Wolfe, M.D., director of Public Citizen’s Health Research Group.

The Health Research Group has twice petitioned the FDA to remove this dangerous drug from the market, first in 1983 and most recently in 1995. The drug, also known as gamma benzene hexachloride, is toxic to the central nervous system and bone marrow, and is a possible carcinogen.

"There are much safer alternative treatments for scabies and lice infestation, such as the over-the-counter medication Nix, which contains permethrin, a product that is effective and much less dangerous than toxic Lindane," Wolfe said.

The FDA ordered a new "black box" warning on the the drug’s label, stating that Lindane should be used with caution on patients weighing less than 110 pounds. The FDA also limited product package sizes to 1 and 2 ounces and required a Medication Guide containing instructions for use and information about adverse effects.