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FDA cites toxic risk of popular head-lice drug
"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 — almost 10% of all prescriptions for head lice and scabies — were written from January to November 2007, according to the tracking firm IMS Health."
FDA cites toxic risk of popular head-lice drug - USATODAY.com
"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 — almost 10% of all prescriptions for head lice and scabies — were written from January to November 2007, according to the tracking firm IMS Health."
FDA cites toxic risk of popular head-lice drug - USATODAY.com