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The sole U.S. maker of an insecticide-based treatment for head lice has stopped promoting the product after a sharply worded warning from the Food and Drug Administration that its marketing misled consumers by downplaying the rare, but serious, risks of the treatments.
The move follows years of controversy over prescription shampoo and lotion treatments that contain the insecticide lindane, including a ban on their use in California. Lawmakers in Michigan, New York and Minnesota are considering curbing use of the products.
In a little-noticed December letter, the FDA cites concern over some of the information drugmaker Morton Grove Pharmaceuticals provided on websites and in mailed materials, including a statement by the company that treating head lice effectively requires two applications, several days apart. That is “extremely alarming given that retreatment with Lindane Shampoo can lead to increased exposure and possibly death,” the FDA says.
Millions of cases of head lice and body mites are reported each year in the USA, often among children. More than 166,000 prescriptions for lindane treatments â€” almost 10% of all prescriptions for head lice and scabies â€” were written from January to November 2007, according to the tracking firm IMS Health.
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Hospitalizations, seizures and deaths have been reported after the use of Lindane Shampoo and Lindane Lotion, according to the products’ warning label. The FDA requires the prescriptions to carry that warning. The warning label also cites “lindane toxicity, verified by autopsy” in two deaths: an infant and an adult who used the product to commit suicide.
Morton Grove was purchased by Wockhardt, an India-based company, in October. It says in a response letter that the new owners “do not believe” that the marketing materials “intended to downplay” the risks associated with the shampoo. Morton Grove President and CEO Kurt Orlofski said in an interview the firm has stopped its promotion, as requested by the FDA, until it develops new marketing materials.
“The FDA has had a number of occasions to review the safety and efficacy of product and keep it or pull it: They have kept it on the market,” Orlofski said. “It’s an important second-line therapy.”
The FDA says lindane products are useful as a last resort against head lice and scabies. “The benefit of the drug for treating scabies and lice outweigh the risk,” FDA spokeswoman Rita Chappelle said.
Several treatments for head lice are available, including combing out the lice and their nits, over-the-counter products and prescription treatments.
In 2006, the Environmental Protection Agency banned lindane as an agricultural insecticide, citing its toxicity. About 50 other countries already ban or restrict the agricultural use of lindane.