FDA cites risk of ne in head lice shampoo

[Guest guest]

MN Kids Enviro Health <mnkids@...> -- posted by dwallinga@...

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Moderator note: Agricultural uses of lindane were banned in 2006 due to

concerns about its toxicity, but uses in children's products remain on

the market in the US. Safer and effective alternative products are

readily available. -- Wallinga, MD

Head-lice drug promotions halted

FDA cites risk of toxic ingredient in shampoo

By Appleby

USA TODAY, January 31, 2008, p. 1A

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

ne 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.

Hospitalizations, seizures and deaths have been reported after the use

of ne Shampoo and ne 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.

Find this article at:

http://www.usatoday.com/printedition/news/20080131/1a_bottomstrip31_dom.

art.htm

States may restrict lice treatments

At issue: Regulation of FDA-approved products

By Appleby

USA TODAY, January 31, 2008, p. 3A

Lawmakers in at least three states are considering restricting the use

of treatments for head lice and body mites that contain the insecticide

lindane, raising questions about whether states can regulate products

approved by the Food and Drug Administration.

California lawmakers banned the prescription use of lindane beginning in

2002, amid concerns that lindane levels in wastewater treatment systems

exceeded state standards. Since then, lindane has dropped far below

allowable levels, says a study published online in December in

Environmental Health Perspectives, a journal of the National Institute

of Environmental Health Sciences.

New York, Michigan and Minnesota are considering restrictions.

The sole U.S. supplier of the treatments, Morton Grove Pharmaceuticals,

says its products have been certified by the FDA as safe and effective.

It's vowing to fight state efforts to restrict their use.

" We don't believe states have the right or the power to overrule a

federal agency like the FDA, " says Morton Grove CEO Kurt Orlofski.

" There have been other states that have tried to do the same thing, and

we have been very successful in getting that legislation stopped. "

States enact all kinds of public health laws, from overseeing

restaurants to monitoring doctors. Whether state laws also can override

the FDA is not clear, say attorneys who specialize in FDA law.

" There's a conflict between a 200-year-old concept of parens patriae,

where states act as a parent for its citizens on health and safety

matters, and ... a pharmaceutical product which the federal government

has said is safe and effective, " attorney Barton Hutt says. " It's

about as big a conflict as you can imagine. "

Attorneys familiar with FDA law say neither the states nor Morton Grove

have a slam-dunk argument: It all depends on how the legislation is

written. They say state authority also could be affected by rulings in

upcoming Supreme Court cases exploring whether consumers can sue the

makers of FDA-approved drugs and devices.

Lawyer Vodra says an outright ban, such as that in California,

may create fewer problems than restrictions on lindane treatments.

That's because some restrictions could force the company to create

special warning labels to satisfy state demands, overstepping their

authority because states can't interfere with interstate commerce.

The proposed bills take different approaches:

*Michigan. A bill would require that doctors supervise the lindane

treatments.

" My bill is not a total ban; it's a kind of compromise, " says sponsor

Rep. Ted Hammon, a Democrat. He says states have authority to regulate

the treatments. " Not only do I have a moral obligation, " he says, " but I

have a constitutional right to ban any type of chemical that is

detrimental to the environment. "

Michigan lawmakers last week heard testimony from Mark , director

of the Pediatric Environmental Health Specialty Unit at the University

of California, San Francisco, that after the California ban, lindane in

the state wastewater treatment plants fell dramatically.

An earlier bill to ban lindane treatments failed.

*New York. A bill would bar the use of lindane treatments on pregnant

women and children under 16. An earlier bill, which would have banned

all uses, failed in 2006.

" This is a dangerous product, and one that serves no purpose because the

problems can be handled in better ways, " says Assemblyman Harvey

Weisenberg, a Democrat who introduced the new bill.

Pamela LaBrake is among parents and environmental groups pushing the

state to act.

Eleven years ago, she says, she used a prescription shampoo containing

lindane on her 7-year-old son. She didn't know that the product - made

by a manufacturer that no longer markets it - was supposed to be used

just once. She washed his hair with it four times during a three-month

period because his head lice kept coming back.

Now 18, her son has neurological problems. LaBrake says she believes

they began with those shampoos.

The FDA in 2003 required treatments with lindane to come with strict

warnings that they should be considered only after other treatments are

tried and should only be used once. LaBrake wants state lawmakers to go

further.

*Minnesota. Two bills are pending. One would ban treatments using

lindane. The other would create a committee to review the scientific

literature on lindane treatments and make recommendations to the

Legislature.

While all drugs have risks, Orlofski of Morton Grove, now the only maker

of the treatments, says the products are safe when used properly and

provide a valuable addition to the arsenal against head lice and body

mites, called scabies.

The FDA estimates that head lice affect an estimated 6 million to 12

million people a year, and children often are sent home from school if

they have lice. Scabies is a form of mite that burrows into the skin.

Although neither condition is life-threatening, both cause itchiness,

and sometimes infections. Several treatments are available.

Researchers debate the safety of lindane. , at UCSF, says lindane

treatments " are more dangerous to kids and are less effective " than

alternative prescriptions and over-the-counter treatments. But

Pollack, a Harvard School of Public Health researcher who also provides

technical advice to a company seeking a new head lice treatment, agrees

with the FDA that the benefits outweigh the risks, when it is used as a

last resort and applied properly.

" As lindane has been deemed safe and effective for its intended use, the

FDA has no intention of taking any further action with this product, "

spokeswoman Rita Chappelle wrote in an e-mail.

Find this article at:

http://www.usatoday.com/printedition/news/20080131/a_lindaneinside31.art

..htm

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