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.
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