FDA refuses to ban drug that has killed 17

Despite vigorous protests from consumer health organizations like Public Citizen, the U.S. Food and Drug Administration (FDA) has refused to ban products containing Lindane, a prescription drug used to treat scabies and lice. The FDA has already received reports of at least 17 deaths associated with the use of Lindane and numerous reports of neurological 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.

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’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 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 one and two ounces and required a “Medication Guide” containing instructions for use and information about adverse effects.

SOURCE: Public Citizen, Media Advisory, March 28, 2003.