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Head Lice Drugs Toxic, FDA Warns

Jan 31, 2008 | Parker Waichman LLP

Linade Shampoo and Lindane Lotion, two popular used to treat head lice can be toxic, the Food & Drug Administration (FDA) has warned.   Morton Grove Pharmaceuticals, which makes Lindane Shampoo and Lindane Lotion, is the only U.S. maker of an insecticide-based treatment for head lice.  The company has stopped promoting the Lindane products after receiving a stern warning from the FDA in December that said Morton Grove’s marketing misled consumers by minimizing the rare, but very serious, risks of the insecticide-based head lice drugs.

There has been much controversy in recent years over prescription shampoo and lotion treatments used in the treatment of head lice and that contain the insecticide lindane.  As a matter-of-fact, lindane’s use is banned in California and lawmakers in Michigan, New York, and Minnesota are looking into restricting use of the products, as well.

The FDA warning cites concern over some of the information drug maker 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.  According to the FDA, this is "extremely alarming given that re-treatment with Lindane Shampoo can lead to increased exposure and possibly death."  According to the products' warning label, hospitalizations, seizures, and deaths have been reported after the use of Lindane Shampoo and Lindane Lotion; the FDA requires that the prescriptions carry that warning.  The warning label also cites "lindane toxicity, verified by autopsy" in two deaths:  One infant and an adult who used the product to commit suicide.

In the U.S., millions of cases of head lice and body mites are reported each year, with the majority of cases occurring among children.  In the period from January 2007 to November 2007, more than 166,000 prescriptions were written for lindane treatments accounting to nearly 10% of all prescriptions for head lice and scabies, according to the tracking firm IMS Health.

Morton Grove Pharmaceuticals was purchased by Wockhardt, a company based in India, this past 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 that the firm has stopped its promotion of the product, 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."

In 2006, the Environmental Protection Agency (EPA) banned lindane as an agricultural insecticide, citing its toxicity and about 50 other countries already ban or restrict the agricultural use of lindane.  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," according to FDA spokeswoman Rita Chappelle.

Head lice—pediculosis—are parasitic wingless insects that live on people's heads and feed on human blood.  Several treatments for head lice are available, including combing out the lice and their nits—or eggs, over-the-counter products, and prescription treatments.

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