Contact: Pamela LaBrake
For Immediate Release email:hlabrake@yahoo.com
USE CAUTION WHEN TREATING HEAD LICE
With school just
around the corner a reminder to parents and healthcare providers concerning the insecticide lindane.
In 2003 the
FDA (Food and Drug Administration) added a blackbox warning to lindane shampoo and lotion. Lindane shampoo is a prescription
treatment for headlice and lindane lotion for scabies.
A blackbox warning means that medical studies indicate a drug
carries a significant risk of serious or life threatening adverse effects. It is the strongest warning that the Food and Drug
Administration requires.
Young children, preschool through elementary age, are most prone to head lice infestation
so the following information by the FDA cannot be stressed enough.
Lindane is contraindicated for use in neonates and
should be used with extreme caution in children and in individuals weighing less than 50 kg (110 lbs). Among adverse event
reports in which the outcome was serious (resulted in hospitalization, disability or death), the very young and the elderly
appeared to be more susceptible to Lindane’’s adverse effects and had worse outcomes. http://www.fda.gov/cder/foi/label/2003/006309shampoolbl.pdf
The
risk of neurologic side effects associated with Lindane is known from clinical trials, spontaneous post-marketing reporting
data and literature reports. These side effects have ranged from dizziness to seizures. In post-marketing reports, neurologic
side effects occurred in patients who misused Lindane, as well as in patients who used Lindane according to labeled instructions.
Among the adverse event reports in the FDA database, 70% reported neurologic events including seizure, dizziness, headache
and paresthesia.
There are less toxic over the counter treatments. Most important is to get a good lice comb to remove
lice and nits.
Dr. Greene has excellent information on his website on how to safely treat head lice with inexpensive
ingredients, many found right in your home.
http://www.drgreene.com/21_640.html
Links for Parents and School
Nurses
NY guide to getting rid of lice and nits http://home2.nyc.gov/html/doh/html/scah/lice.shtml
Getting
rid of lice naturally http://www.wikihow.com/Get-Rid-of-Lice
A School's Guide to the 'Nitty-Gritty' About Head
Lice
Residents asked to avoid Lindane for treating lice
By Gene Deason - Brownwood Bulletin
Published: Monday,
September 15, 2008 8:05 AM CDT
Area residents are being reminded that they have a variety of options
other than Lindane, also known as Kwell, to treat lice, and those options are recommended by municipal officials to avoid
wastewater contamination and violation of environmental regulations.
“This concern comes up every fall when school
starts,” Dr. Jim Hays, medical director for the Brownwood-Brown County Health Department, said. “Children get
back to school, and it seems there is usually an outbreak of head lice. Then, it seems a lot of students get a cold.”
Hays
said environmental law states that any detectable amount of Lindane in municipal wastewater is considered to be a contaminant.
However, detection methods have become so sophisticated since the law was written, that even trace amounts as small as one
part per trillion can be isolated. In effect, any Lindane in the water is a violation.
Products used to kill lice are
topical, and the medication - which is pesticide - gets washed down drains into wastewater systems.
“Most doctors
don’t prescribe Lindane for lice any more,” Hays said. Physicians tend to specify treatments like Ovide, Nix or
Rid instead, and those have proven to be effective.
Hays described the pesticide Lindane as “persistent,”
meaning it lingers in the environment for a long period and sustains its toxic effect on wildlife and humans. The available
alternatives are not “persistent,” he added.
The Agency For Toxic Substances and Drug Registry ranks lindane
33 out of 275 other substances on its Priority List of Hazardous Substances and the Environmental Protection Agency has severely
restricted the use of Lindane as an agricultural pesticide due to Lindane’s adverse health effects, according to Lindane
Education and Research Network, a project of the National Pediculosis Association.
3. Combing. Separate a mass of hair that is slightly wider than the width of the metal lice comb and about
3/4 inch in the other direction. It is important to separate the hair into small sections so you can more easily see lice
and nits.
Hold the mass of hair with one hand. With the other hand, hold the lice comb in a slanting position with the
teeth toward the head.
Insert the comb as close to the scalp as possible since the eggs are first laid within 1/2 inch of the scalp.
Gently pull the comb slowly through the hair several times. Check the hair carefully.
Comb one section at a time and check each section again. Pin the hair out of the way curling it flat against
the head. Whenever you comb out nits or live lice, dunk the comb in the soapy water. Make sure the comb is clean before you
use it on the hair again. Frequently remove hair and other debris from the comb with a tissue. When the bowl is full, flush
its contents down the toilet and refill the bowl with soapy water. Continue combing.
After Combing. Flush the contents of the bowl down the toilet. Shampoo the hair at least twice to remove the
oil. When the hair is dry, check for stray nits and remove those hairs individually with a pair of small, pointed scissors.
Lice can be controlled without resorting to shampoos with pesticide, but this
depends on thorough combing of the hair with a special lice comb. Because reinfestation from playmates is common (regardless
of the treatment used), parents may wrongly assume that the first treatment wasn’t strong enough and turn to something
more toxic. To minimize reinfestation, schools are urged to adopt a "No Nit" policy (see below) and to educate teachers and
students, but especially parents, in how to find, control, and prevent head lice.
Shampoos with Pediculicides
We do not recommend the use of insecticides except as a last resort in extreme
cases. The scalp has many blood vessels that are close to the skin, making it easy for toxic substances to be absorbed directly
into the bloodstream. Absorption is greater when the skin is warm and the blood vessels are dialated.
For many years, lindane (commonly referred to as Kwell®), an organophosphate
pesticide, was the treatment of choice; it is still recommended by many medical personnel who have not taken the time to acquaint
themselves with its potential health hazards to humans.
Lindane is absorbed through the skin into the bloodstream; once absorbed,
it can be carried throughout the body to tissues and organs. In pregnant women, it can travel across the placenta to the developing
fetus.
Lindane is available only by prescription. We do not recommend its use at
any time. In many cases, its chronic overuse has produced resistant lice and rendered lindane ineffective.
This document was produced for USEPA (Document #909-B-97-001) by the Bio-Integral
Resource Center, P.O. Box 7414, Berkeley, CA 94707, March 1997.
Comparative efficacy of two nit
combs in removing head lice (Pediculus humanus var. capitis) and their eggs.
Anton Breinl Center for Public Health and Tropical Medicine, School of Public Health , Tropical Medicine and Rehabilitation
Sciences, James Cook University , Townsville , Queensland , Australia .
Background Fine
tooth lice combs fall into two classes based on the material from which their teeth are made: plastic or metal. Metal combs
are further divided into those that are made from a flat sheet of metal, and hence have rectangular teeth, and those that have cylindrical teeth embedded
in a plastic base. Methods The efficacy of two fine tooth combs [Lice Meister comb (metal) and Lady Jayne comb (plastic)]
in removing head lice (Pediculus humanus var. capitis) and their eggs from the hair of children was evaluated after treatment
with a viscous head lice product (Lice Blaster; Emerald Forest Pharmaceuticals Pty Ltd, Currumbin, Qld, Australia). The hair
of 27 children was divided into two sections sagitally, and each comb was randomly assigned to one half of the hair, and the
lice and eggs removed by the combs were counted. Results In 96% of subjects, the Lice Meister comb removed more eggs than
the Lady Jayne comb, with an average of three to four times more hatched, dead, and live eggs removed. The Lice Meister comb
removed more lice than the Lady Jayne comb in 10 subjects, the same in eight subjects, and less in nine subjects. Conclusion
Overall, the Lice Meister comb is recommended as a more effective comb for use in controlling head lice infestations, whether
employed with conditioner or with insecticide treatment. This appears to be the first study investigating the efficacy of
nit combs in vivo. Further research is needed to determine which characteristics of fine tooth combs are the most important
in removing head lice eggs.
PMID: 18173523 [PubMed - in process]
Next time, just shave your head...at least you'll live through it...
By Thomas Keister
February 02, 2008
I have said for years that the Food and Drug Administration is, for the
most part, worthless, a wind-sock in a land devoid of breeze. For every report of tainted Chinese crap hitting the mainstream
media last year, I swear I could count three or four commercials touting some cockamamie (no pun intended) erectile dysfunction
treatment or psuedo-trendy diet pill, carrying that world-famous disclaimer. You know the one, about how none of the statements
in the ads have been "verified" by the Food and Drug Administration." Never have received an answer as to what it is the FDA
is doing where they don't have any time left to raid the late-night medicine cabinet. To be fair, when the FDA more or less,
sort of kind of gets one right, they deserve a little notice, more or less. Sort of kind of. In a letter the FDA issued in
December, concerns were stated over the information Morton Grove Pharmaceuticals was using in web and print advertising of
its head lice treatments containing lindane, an agricultural insecticide banned for use as such by the EPA in 2006. Morton
Grove is the only manufacturer of lindane in the United States. I'm far beyond the point in my digestion of 21st century life
where I question how a banned insecticide is useful as a scalp treatment, but there for the grace of blind consumerism, go
I. Despite the fact that hospitalization, seizures, and even death have been reported from the use of Lindane Shampoo and
Lindane Lotion, nearly ten percent of the prescriptions for head lice treatments written in 2007 were for lindane-based treatment,
over 166,000. To clarify, the hospitalization, seizures, and death are listed on the warning label, by the FDA's
own requirements. Ask your family doctor, just out of sheer morbid curiousity, what he or she would prescribe, and
see what they answer. Be cure you have a Yellow Pages handy, just in case.
While Morton Grove Pharmaceuticals has suspended promotion of their Lindane
products, at the request of the FDA, to allow the company time to develop new marketing materials, I find it a half-bubble
past the center of sanity the products are even still allowed on the market. One of the statements the FDA, miraculously,
took issue with was one by Morton Grove that the effective treatment requires two treatments. When the FDA calls something
"extremely alarming," you know they have actually been paying attention, or at least we should hope... Morton Grove
president/CEO Kurt Orlofski ventured beyond what I normally consider yes-holing, stating "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, it's an important second-line
therapy." As I have mentioned in the past, the fact I have "Dr." in front of my name is irrelevant. I bought that honorary
degree online for $40, fair and square, but I'm still willing to argue the importance of lindane as a treatment,
and regardless of how many FDA yes-holes bleat in the background over how benefits outweigh risks, yeah, yes, hell yes
I am willing to argue against rubbing a banned agricultural insecticide on some kid's scalp, anybody's scalp once,
let alone a second time. When a government agency's standard operating procedure seems to land somewhere in the grey area
between "what you don't know won't hurt you," and "what doesn't kill you, makes you stronger," then it seems even more so
that arguments like mine are made for me. American
Chronicle Feb. 4, 2008
WRONGFUL DEATH VERDICT
JURY AWARDS $1,650,000.00
IN TOTAL DAMAGES
On March 2, 2007, a Talladega County jury returned a verdict for the Plaintiff in a medical malpractice
case against a local physician and his employer, Baptist Health Centers, Inc. The jury found the healthcare providers liable
for the death of a 6 ˝ month old child. The child died due to toxicity from Lindane,
a medication used in the treatment of head lice and scabies. The jury found that the physician wrongfully prescribed the drug
and/or inadequately instructed the mother with respect to use of the medication.
A set off of $1,150,000.00 was allowed against the verdict due to previous settlements with the
manufacturer and the local pharmacy. The case was tried by Heninger Garrison Davis partner, Tim Davis and Talladega attorney,
Steve Adcock.”
My heartfelt sympathies go out to the parent's and family of this baby.
EPA's own words on use of lindane
for headlice and scabies
iv. Pharmaceutical use
Lindane is also used as a treatment for lice and scabies. Individuals
who use lindane pharmaceutical products will be exposed to lindane in amounts that will exceed exposure from the seed treatment use. The pharmaceutical use, though, is also a source of exposure to the general population. EPA believes that lindane from the pharmaceutical
use may reach drinking water via "down the drain" release; that is, lindane enters drinking water when individuals using the
pharmaceutical products wash off their hands/bodies. Based on information
from Los Angeles County, California, EPA estimated average effluent concentrations of lindane discharged from publicly owned
treatment works to be 0.03 ppb (2002 RED at p. 23). In fact, California
banned the pharmaceutical uses of lindane due to concerns about water contamination and acute neurotoxicity concerns from
direct application. Although FDA has recommended that lindane be prescribed as a second line treatment since 1995, these products
remain a source of exposure.
A. Presence of Lindane in Breast Milk
Although there currently are no programs in the United States for monitoring lindane levels in human breast
milk, EPA believes that lindane is present in the breast milk of at least some nursing mothers in the United States. In general,
lindane is very persistent and highly soluble in fat or fatty tissue. Therefore, it has the potential to bioaccumulate in
the food chain and bioconcentrate in microorganisms, invertebrates, fish, birds, and mammals. In practical terms, this means
that when women are exposed to lindane through food, water, or the atmosphere, they will accumulate lindane residues in their
fatty tissue, including breast milk and breast milk fat, and that these lindane residues will remain there for an undetermined
amount of time.
2 Thus, to the extent women
in the United States are exposed to lindane, EPA believes that that lindane likely will accumulate in their breast milk or
breast milk fat.
Moreover, in the 1970s and 1980s, lindane was detected in breast milk in women in Binghamton, New York; Saint
Louis, Missouri; several places in Mississippi, and in Philadelphia, Pennsylvania.
Forty years after the lesson taught by the notorious pesticide DDT, it might be hoped that fat-loving toxins would have
been eliminated from human tissues. However, a US study has shown that levels of some flame retardants and organochlorine
pesticides in breast milk are still high enough to warrant concern, despite many of them having been phased out of use.
Kurunthachalam Kannan and colleagues from the New York State Department of Health, US, took breast milk samples from 38
mothers in the state of Massachusetts, and analysed them for various flame retardants and organochlorine pesticides, such
as DDT and lindane. They found that although levels varied widely between individuals, there was a clear correlation between
amounts of different contaminants. This suggests a common source of exposure, which is likely to be household dust or food,
says Kannan.
The most prevalent contaminants in the samples studied, says Kannan, were polybrominated diphenyl ethers. These are flame
retardants applied to household furnishings and electronic goods that are still widely used in many countries. The levels
of these chemicals were between ten and 100 times higher than in Asian and European samples, which can be explained by the
great market demand for them in the US, said Kannan.
The scientists point out that despite the continued presence of these contaminants, breast milk is still the best food
for babies. Gina Solomon, senior scientist at the Natural Resources Defense Council, a US-based non-governmental environmental
and health advocacy organization based in New York, agreed. 'The benefits of breast milk still outweigh any harm from these
contaminants, and we must control or eliminate the chemicals rather than stop mothers from breast-feeding,' said Solomon.
Lindane use in geriatrics
Safety and efficacy of lindane have not been specifically studied in geriatric patients.
Lindane shampoo and lotion should be used with caution in geriatric individuals since this age group may
be at increased risk of serious neurotoxicity. There have been at least 4 reports of death in geriatric adults following application
of lindane lotion for the treatment of scabies. Two of these patients died within 24 hours of application
of the drug, one died 41 days after application and had a seizure on the day of death, and one died of an unreported cause
of death on the day of treatment.
In 2002 the FDA did a review of lindane, searching the Adverse Events Reporting System
(AERS) database for reports of adverse events associated with lindane. From 1974 to 2002, there were 488 reports with the
most common being "drug ineffective," followed by convulsions, dermatitis, and dizziness.
A review of the most serious cases described 15 deaths, 46 hospitalizations, seven life_threatening outcomes, and six cases
of congenital anomalies.
One service-connected claim involving exposure to lindane was submitted to the Department of Veterans
Affairs (VA) Board of Veterans Appeals. The initial claim was denied but was subsequently appealed. The appellant, the surviving
spouse of a veteran, contended that her husband was exposed to various toxic chemicals, particularly lindane, during the Gulf
War, and as a result of exposure to lindane, the veteran developed pancreatic cancer from which he subsequently died.
In the appeal, the Board considered scientific opinions presented on behalf of the appellant and by the VA.
The scientific opinion on the behalf of the appellant maintained that lindane likely caused the veteran’’s cancer,
while the VA did not recognize an association between lindane exposure in the Gulf and the veteran’’s cancer.
The Board concluded that the preponderance of the evidence presented favored the appellant’’s claim. The Board
found that it was "reasonably probable" that the veteran’’s pancreatic cancer, which caused his death, resulted
from his exposure to lindane during the Gulf War. Therefore, the Board granted service connection for the cause of the veteran’’s
death
http://gulflink.osd.mil/pesto/pest_s06.htm
EPA bans Lindane, now it's time for NY to ban it for
headlice and scabies, and the FDA to ban it completely !!!
Citizens’ Environmental Coalition
Healthy Schools Network
Learning Disabilities Association of NYS
New York Public Interest Research Group
Parents Against Lindane
Pesticide Action Network of North America
MEDIA RELEASE
FOR IMMEDIATE RELEASE: FOR MORE INFORMATION CONTACT:
August 2, 2006 Laura McCarthy, Citizens’ Environmental Coalition
518-462-5527
Pam LaBrake, Parents Against Lindane 518-346-7190
Stephenie Hendricks, Pesticide Action Network 415-981-6205, x 309
EPA Announces Halt to Lindane for Ag Use
Risk to Children Remains through Pharmaceutical Products:
Groups Call for FDA, NYS to Ban All Use
(Albany) EPA today announced the withdrawal of all agricultural products in the U.S. containing the pesticide lindane.
Environmental health groups around the country and in New York State applaud the step, but are critical of EPA’s claim
to be the best agency in the world for pesticide regulation, and are calling for phaseout of the remaining uses of lindane.
All uses of lindane have already been banned in 52 countries around the world. Until today, the U.S. used up to 230,000
pounds of lindane yearly in seed treatment products, mostly on corn and wheat. The withdrawal allows continued use of existing
stocks of lindane seed treatment products. Lindane use continues to be allowed for treatment of lice and scabies in pharmaceutical
products regulated by the Food and Drug Administration (FDA).
"The phaseout of lindane’s agricultural uses is a long overdue step," says Bobbi Chase Wilding, Associate Director
of Citizens’ Environmental Coalition, "We’re pleased the U.S. is finally moving to join the rest of the international
community that has already stopped using this harmful pesticide. The FDA needs to follow suit so that no American is exposed
to this highly toxic chemical. Since FDA has thus far refused, we call on the NYS legislature to act now to protect our children."
"It’s about time we stopped using this long-lasting, neurotoxic pesticide," says Kristin Schafer, Program Coordinator
for Pesticide Action Network (PAN). "We’re pleased EPA has finally done the right thing – but this chemical linked
to brain tumors and hormone disruption is still allowed in lotions and shampoos. We’re now asking for the public’s
help to get FDA to withdraw lindane’s pharmaceutical uses."
-More-
Pharmaceutical uses of lindane for lice and scabies have been banned in California since 2002, and legislation promoting
similar bans is moving forward in other states including Michigan and New York.
"Lindane is no longer allowed on pets or seeds, why are we still allowing use on kids?" asks Laura McCarthy, Program Associate
with Citizens’ Environmental Coalition in Albany, New York. "We don’t need lindane. There are safer, affordable,
more effective treatments available."
The New York State Legislature has bills (A.4162A and S.5619) pending in both houses. The groups called on State leaders
to protect New Yorkers and to not wait for the FDA. The groups thanked Assemblymembers Weisenberg, Dinowitz, Ortiz, Perry,
Espaillat, Arroyo, and Gottfried and Senators, Flanagan, LaValle, and Marcellino for their leadership as sponsors of this
state legislation.
Lindane is a known neurotoxin that can cause seizures, damage the nervous system, and weaken the immune system. Exposure
may also cause cancer and disrupt the human and animal hormone systems.
"When I found out that lindane was the source of my sons illness, my emotions ran the gamut from fear, to guilt, to anger
that the FDA would allow this toxic pesticide to be used on children," said Pam LaBrake, a mother whose son suffers permanent
effects due to lindane and who has been lobbying for the Lindane ban for the past eight years. "No other child and no other
mother should have to suffer from exposure like this. A full ban of lindane in New York is a necessary next step."
In an E&E News story, Jim Gulliford, assistant administrator for EPA's Office of Prevention, Pesticides and Toxic Substances,
explained why the agency chose to voluntarily cancel the chemical, stating that lindane "is recognized internationally as
one of the most toxic, persistent, bioaccumulative pesticides ever registered."
The lindane news precedes the controversial announcement expected Thursday of EPA’s reregistration of more than 20
organophosphate and carbamate pesticides, despite strenuous objections voiced by thousands of EPA staff scientists who say
these chemicals pose unacceptable risk to children’s health. In a news advisory released Tuesday, EPA highlighted lindane’s
withdrawal (a 29 year process) and Thursday’s controversial reregistrations as evidence that "U.S. pesticide safety
is the highest in the world." Public health and scientist advocacy groups staunchly disagree, and are calling for an end to
industry pressure on EPA and FDA government scientists.
My heartfelt thanks to William for doing this informative and caring story.
Toxic consequences
Mom links son's condition to lindane, a lice treatment, and seeks to ban it
By
William Brantley, Staff writer First published: Tuesday, May 3, 2005
In the world of what would have been, her son Matthew would have started playing football
this past year. His childhood dream was to play for the Dallas Cowboys.
Pamela LaBrake of Schenectady can picture in that world of what would have been how Matthew, who recently turned 15, would
still be an outgoing, confident, happy kid with lots of friends and a smile big enough to make you do the same.
Instead of what would have been, LaBrake has managed to live with what is and what has been -- Matthew has been a quieter,
more withdrawn boy with convulsive disorders and a variety of other health issues since soon after Dec. 18, 1997, when Matthew,
then 7 years old, was sent home from school with head lice.
"I called (the doctor) and told them that he was 7," said LaBrake, recently, sitting in the den of her mother's house in
Albany. "They prescribed a lindane shampoo. I picked it up within an hour."
Lindane is the common name for an organochloride pesticide known as gamma benzene hexachloride. Since the 1940s, it has
been used in the United States as an agricultural insecticide and as a chemical treatment for lice and scabies.
In shampoo form, lindane is generally meant to be used only once, in a very methodical way, as a "second-line" treatment.
LaBrake found this out later. She said that because she hadn't received any explicit special instructions for using lindane,
she figured she'd use it on Matthew just like any other shampoo. That's what she did.
The problems started a few weeks later. Matthew's eyes were swollen and red. They rolled around in his head. He was struck
by twitches and spasms.
The first doctor who saw Matthew, in early January 1998, found a scraped cornea and diagnosed him with conjunctivitis.
At that point, LaBrake hadn't considered a correlation between Matthew's problems and the lindane shampoo. That changed
a couple of months later, when she saw a television news report about the possible side effects of lindane.
"It was like they were describing Matthew," said LaBrake. "Oh my god, I knew right away."
Finding out
From that point on, LaBrake began to find out everything she could about lindane. She filled notebooks and folders with
information about the pesticide.
She got in touch with doctors, pharmacies, legislators, other parents, the U.S. Food and Drug Administration, the Environmental
Protection Agency and organizations trying to get the substance banned.
She filed Freedom of Information requests, posted letters on Internet message boards and watched, guilty and helpless,
as Matthew's condition immediately worsened, then refused to go away.
In September 1998, nine months after LaBrake used the lindane, a neurologist saw Matthew and concluded in his report that
the boy's symptoms were "consistent with the syndrome of acquired epileptic aphasia," a convulsive condition. Later, he would
receive other diagnoses: epileptic encephalopathy, cortical irritability, cerebral dysfunction.
Going through changes
After a while, it didn't matter to LaBrake what they called it. The worst part was watching her son and realizing he might
not ever be the same again.
He withdrew from other kids. He quit playing sports. He began dreading school.
"He remembers how he was before," said LaBrake. "When he was younger, he used to say, 'Why did you use that shampoo on
me?' He doesn't say that anymore."
Although LaBrake is not taking any legal action regarding her own son's case, she has spent the past eight years actively
seeking a ban on lindane.
Today, a child is less likely to receive a lindane shampoo prescription to treat head lice.
A little more than two years ago, the Food and Drug Administration issued a public health advisory concerning the use of
lindane shampoo and lotion. It required lindane shampoo and lotion bottles to come with a "black box" warning highlighting
the risks associated with the products.
"While FDA believes that the benefits of lindane outweigh the risks when used as directed, given the potential for neurotoxicity,
patients should only be treated with these medications if other treatments are not tolerable or other approved therapies have
failed," the March 28, 2003, advisory stated.
New advisories
In addition to stressing the use of lindane as a "second-line therapy," in essence a fall-back option when nothing else
has worked, the FDA advised caution in using lindane on anyone weighing less than 110 pounds. "These warnings," the advisory
read, "are based on reports to the FDA's voluntary reporting system, which described approximately one half of reported adverse
events occurred in pediatric patients."
The advisory also stressed that each new prescription of lindane shampoo or lotion must be accompanied by a "Medication
Guide" spelling out the instructions for use and the information about the possible side effects of lindane.
For some, this warning isn't enough.
In 2000, California became the first and, so far, only state to ban the use or sale of lice and scabies treatments using
lindane. That bill cited not only the health concerns associated with the direct use of lindane but also the toxic polluting
power of lindane being flushed into the water system because it is still used in agriculture.
A similar bill has been passed by the state House of Representatives in Illinois. A hearing on the bill is scheduled to
take place Wednesday in the Health and Human Services Committee of that state's Senate.
The state of law
In New York, Assemblyman Harvey Weisenberg of Long Beach has sponsored a bill to ban lindane. He said he first became aware
of lindane because a constituent suffered brain damage after using it.
"The evidence has proven that lindane is not only detrimental to the person who's using this product but also to the environment,"
said Weisenberg. "It has a warning on it (to) not use it on animals. If we don't use it on animals, why the hell would we
use it on a child? It just doesn't make any sense."
The bill has been put on the committee's agenda for next Tuesday, May 10.
A number of public interest groups, including the Citizens' Environmental Coalition, the New York Public Interest Research
Group, Physicians for Social Responsibility and the Healthy Schools Network have voiced strong support for the ban on lindane.
The ban seems to make sense, said Erin Cinelli, a pharmacist and adjunct faculty member in the department of pharmacy practice
at the Albany College of Pharmacy. "You don't really see it too much anymore, anyway. I've only dispensed it once," said Cinelli.
"There are the over-the-counter (head lice treatments), and I'm a big advocate of doing all the manual things, like combing."
Upon hearing last week that the lindane bill was scheduled to be on the agenda soon, LaBrake was excited.
"I didn't want to get Matthew's hopes up, so I explained to him that it has to go through all these different committees
and who knows what will happen," said LaBrake. "I told him that it was a good first step, though. He doesn't talk much, so
he didn't say anything. But when I told him, he did sort of have this little smile."
MORE INFORMATION
* For the U.S. Food and Drug Administration's FAQ on lindane shampoo and lotion, visit http://www.fda.gov/cder/drug/infopage/lindane/lindaneQA.htm
* For the U.S. Environmental Protection Agency's fact sheet on lindane, visit http://www.epa.gov/REDs/factsheets/lindane_fs.htm
* For the Centers for Disease Control and Prevention fact sheet on head lice, visit http://www.cdc.gov/ncidod/dpd/parasites/headlice/factsht_head_lice.htm
* For more information about head lice and head lice treatments, visit http://www.nlm.nih.gov/medlineplus/headlice.html
* For more information about head lice and lindane, visit the Web site of the National Pediculosis Association at http://www.headlice.org
* The text of the bill sponsored by Assemblyman Harvey Weisenberg in the state Assembly Health Committee is available at
http://www.assembly.state.ny.us/leg/?bn=04162
* For the Web site of Morton Grove Pharmaceuticals, the manufacturer of lindane shampoo, visit http://www.mgp-online.com/
* For the Web site of the Ban Lindane Campaign, vist http://www.pan-uk.org/banlindane/
All Times Union materials copyright 1996-2005, Capital Newspapers Division of The Hearst
Corporation, Albany, N.Y.
I want to thank W. Steven Pray Ph.D., D.Ph for writing this informative and supportive letter.
April 12, 2005
Dear Assemblyman Gottfried:
I understand that New York is contemplating a bill that would ban lindane. I am in support of this bill as a pharmacist
and as an expert in nonprescription products.
I have written four textbooks on nonprescription products, several book chapters, and over 250 papers for the pharmacy,
medical, and dental hygiene literature. I have presented educational programs across the United States. One of my areas of
specific expertise is the treatment of head louse infestation.
For many years, I have written and taught about the dangers of lindane and other topical pesticides traditionally used
for head lice. In a speech entitled, "Alternative Lice and Scabies Treatment and Prevention Measures," I presented less toxic
alternatives to lindane on behalf of the Environmental Protection Agency at the 2004 North American Commission for Environmental
Cooperation meeting in Anchorage, Alaska. My paper covering this meeting was not published by one pharmacy journal for fear
of losing support from advertisers. It can be accessed at: http://www.headlice.org/news/2005/growingmenace.htm
While all pesticides are potentially harmful when applied to humans, lindane has unique qualities that justify a worldwide
ban on its use.
1. It is the most toxic head louse alternative, in terms of potential for human morbidity.
2. Resistance to lindane is widespread. For a succinct discussion of the problem, see my research paper at www.factsandcomparisons.com/
assets/hospitalpharm/mar2003_peer3.pdf
3. There are safer alternatives for scabies.
4. Lindane is a persistent environmental toxin.
The manufacturers of all pesticides possess the resources to ensure that toxic ingredients such as lindane remain on the
market, squelching any attempt to remove them. Merely requiring a black box on lindane allows this noxious chemical to remain
on pharmacy shelves around the state. You can take a great step forward in improving the health of your citizens by banning
lindane from New York.
Sincerely,
W. Steven Pray, Ph.D., D.Ph. Author, Nonprescription Product Therapeutics Bernhardt Professor of Nonprescription Drugs and Devices College of Pharmacy Southwestern Oklahoma State University Weatherford, OK 73096 steve.pray@swosu.edu (580) 774-3257
Submission of Information on Lindane
Pursuant to Article 8 of the Stockholm
Convention as specified in Annex E of the Convention
Introductory information
Name of the submitting Party/Observer
NGO Observers: Alaska Community Action on Toxics (ACAT) and
Pesticide Action
Network North America (PANNA) on behalf of the International
POPs Elimination
"The Los Angeles County Sanitation Districts calculated that
a single treatment for head lice, when rinsed down the drain, contributed enough lindane to the water entering treatment facilities to bring 6 million gallons of water over the CTR standard.
Based on a review of California pesticide applicator records and physician surveys conducted by these same districts, there
were no significant agricultural sources in the region, indicating that nearly the entire load was the result of pharmaceutical use.
Initially, an education campaign with pharmaceutical lindane
providers was started to discourage use. While this appeared to decrease the inflow levels of contamination, it was inadequate
to comply with the new standards. A bill was then sponsored in the
California assembly, which passed without opposition, to ban the
sale of all pharmaceutical lindane in the state of California beginning
in Jan 2002.
"Although no systematic evaluation of the consequences of
the California ban on lindane in head lice and scabies treatments
has been conducted to date, an anecdotal survey of medical and public
health authorities conducted by the Los Angeles County Sanitation Districts
noted no difficulties or concerns that have been raised by the ban after over two
years in a population
of over 30 million. Lindane concentrations in wastewater exiting these Districts' treatment plants have declined from non-attainment of the 19 ppt goal to negligible following the 2002 institution of the ban on pharmaceutical sales."
By LAURAN NEERGAARD The Associated Press 3/28/03 5:00 PM WASHINGTON (AP) -- Using too much Lindane to treat lice
infestations can cause deadly brain or nerve damage, federal health officials warned Friday, stressing that the prescription
drug should not be used on babies and "with great caution" on children. The Food and Drug Administration took new steps
to limit how much of the controversial drug people can slather on: Once sold in large bottles, Lindane now is to come
only in 1- or 2-ounce packets for one-time use, and doctors are told not to prescribe more. Lindane is an agricultural insecticide
on which the Environmental Protection Agency imposes strong restrictions. Less-potent versions are sold as creams and
shampoos to be rubbed into the scalp and skin to treat lice and scabies, a similar parasitic infection. Sold since the
1950s, they bear warnings that they can cause potentially fatal neurologic damage. Because safer treatments exist, the FDA
said in 1996 that Lindane should be prescribed only to patients not helped by safer alternatives and warned against overuse.
Lindane is absorbed through the skin, and slathering on too much, or using it more than once, greatly increases the risk.
While Lindane use has dropped, from 1.8 million prescriptions in 1997 to fewer than 1 million last year, people still
misuse the drug, FDA's Dr. Sandra Kweder said Friday. Of 17 reported deaths associated with Lindane use, Kweder cited
two confirmed since 1996: a child given a too-high dose and an adult who applied Lindane repeatedly. Typically, someone who
still itches has ample Lindane left after the first application and ignores the doctor's advice to use it only once --
not realizing that the increased itching could signal that the parasites are dying, Kweder said. So Friday, the FDA limited
the amount patients can buy to a single dose. The agency also put its strongest warning on Lindane, stressing it's not for
babies and must be used with great caution in anyone else weighing under 110 pounds. Even then, it should be used only
after other treatments have failed. The patient advocacy group Public Citizen criticized the FDA, saying effective alternatives
such as over-the-counter Nix are so much safer that Lindane should have been banned.
SA bans farm use of Lindane
By Sheree Bega
The neurotoxin Lindane, the active ingredient in a controversial anti-lice shampoo, is to
be banned in South Africa for agricultural use early next year.
Lindane is also known as Gamma Benzene Hexachloride.
Gerhard Verdoorn, spokesperson for the Association of Veterinary and Crop Associations of SA, said the department
of agriculture had banned all pesticide formulations containing Lindane for agriculture, garden, home and public health use
by March 2009, because it is a persistent organic pollutant and "doesn't fit into modern pesticide science any longer".
"The
product will thus be banned from being manufactured, sold, disposed of and used by any individual or institution," he said.
"It scares me to think that the pesticide industry and the department have taken definitive action on a pesticide,
and yet it's still an over-the-counter drug available to the public, in particular as a medicinal remedy for children.
"This
product should be taken off the shelves immediately by the department of health."
Another lice shampoo sold locally,
Quellada, also contains Lindane.
Mukesh Dheda, the national pharmaco-vigilance coordinator at the health department,
said an investigation into the use of the product is currently being carried out, and the package insert is being reviewed.
"Priscilla
Sehoole, spokesperson for the agriculture department, said: "South Africa is a member of the Stockholm Convention on Persistent
Organic Pollutants (a global treaty to protect human health and the environment from dangerous chemicals) and "therefore deems
it fit to abide with this decision to ban it".
This article was originally published on page 3 of Saturday Argus on November 08, 2008
Lindane (HCH) is banned or restricted in many countries, BUT is still used for headlice and
scabies in the United States
HCH Argentina, Austria, Bangladesh, Belize, Benin, Bolivia, Brazil, Bulgaria, China,
Colombia, Cuba, Cyprus, Denmark, Dominican Republic, Ecuador, Egypt, Fiji, Finland, France, Germany, Greece, Guatemala, Honduras,
Hong Kong, Hungary, Ireland, Israel, Ivory Coast, Jamaica, Japan, Jordan, Kenya, Korea, Liechtenstein, Luxembourg, Madagascar,
Mauritania, Mexico, Moldova, Mozambique, Netherlands, Nicaragua, Panama, Paraguay, Peru, Philippines, Portugal, Singapore,
South Africa, Spain, Sri Lanka, Sweden, Taiwan, Thailand, Turkey, United Kingdom, United States, Uruguay.
Lindane Argentina, Australia, Bangladesh, Belgium, Belize, Bolivia, Brazil, Bulgaria,
Chad, Colombia, Cyprus, Denmark, Dominica, Dominican Republic, Ecuador, Egypt, Finland, Guatemala, Honduras, Hong Kong, Hungary,
Indonesia, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Korea, Lebanon, Madagascar, Mauritania, Moldova, Mozambique, Netherlands,
New Zealand, Nicaragua, Paraguay, Philippines, St. Lucia, Singapore, Sri Lanka, Sweden, Switzerland, Taiwan, Tonga, Venezuela,
Yemen.
Morton Grove Pharmaceuticals files lawsuit against Ann Arbor's
Ecology Center stating the ecology center made misleading statements about lindane.
I commend the Ecology Center for standing their ground and fighting this frivolous
suit, as they have only stated the true facts about lindane.
Morton Grove claims they have lost in excess of $75,000 as a result of "false and
misleading " statements made by the defendants.
But the Ecology Center’s research is thoroughly supported in peer reviewed
journal articles and government data.
On Morton Grove’s website they are the ones with misleading and false information.
They have not stated that the EPA has BANNED lindane for agricultural use. They only say that the EPA feels it is safe for
head lice and scabies when the EPA has no say on "medications".
Morton Grove claims they have lost $75,000, but they don’t state how they have
already paid out over $90,000 to a lobbyist in Albany, NY to fight the lindane bill, and this doesn’t take into account
the extra costs for phone bills and taking members of the assembly/senate out to lunches etc.
Will Morton Grove go after every agency, organization and parent who knows that lindane
is the least effective and most toxic pesticide used on headlice and scabies?
I hope so.
Because not only will they have to pay out much more money then they claim they are
losing, but this will backfire on them.
Because with the media attention this is getting, many more parent’s, school
nurses, pediatricians and politicians will be educated with the correct facts that lindane should have been banned long ago,
now that the the EPA has banned it there will be pressure for the FDA to follow, and our elected officials in our state governments
will have to decide if they want to protect our children’s health, instead of being taken out to lunch.
Here is how the FDA, its advisories and doctors are "supposedly" putting our childrens health first regarding medication
safety. This meeting focused on steroidal dermal medications for children, but can be applied towards any medication applied
to our children's skin. I think any parent will be appalled at what they read. These are items I highlighted, the actual text
is very long, will furnish link if you email me.
FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH PEDIATRIC ADVISORY SUBCOMMITTEEOF THE ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE 8:06
a.m.Wednesday, October 29, 2003
It's been estimated that the FDA receives somewhere between 1 to 30 percent of adverse event reports,
but there's just really no way of knowing what we're receiving. Thinking about it, I consult frequently
in the ICU. Topical products are typically not asked for in the medication history by physicians in practice. So as a non-dermatologist, I think we routinely, even people in academic medical centers, don't pay any attention to
topical medication.
As someone who recertifies in pediatrics and pediatric pulmonology and serving on this committee,
I'm almost amazed at the lack of drug-related questions on board exams. One mechanism __ if more questions about drug reactions
or drug toxicity were put into professional recertification exams, it would force physicians to raise their interest in that
subject because I think the average practitioner gets most of their information from the detail person and probably does not
read the package insert before they prescribe a drug.
Just basically I'm saying this for the recorder here. The younger pediatric patients have a larger surface area to mass
ratio when compared to adults and may be at greater risk of higher systemic exposure to topically applied drugs. A statement
of fact.
DR. FOST: You're asking whether there may be long-term toxicities that we'll never know about.
DR. TEN HAVE: Yes, and the question you asked. I think everybody is concerned about long-term use and less concerned about
the short-term use that the current studies are addressing.
But then the last point is that whatever we do with the label in the box, that's not where it's at. Most of us never read
those. The patients never read those, or not very often and don't know how to interpret because they're rats and dogs and
birds and stuff.
DR. CHESNEY: Just to bring it to your attention or this may not have been __ I think the label
in the box they just don't read. So unless the provider explicitly states it __ and many of us as providers didn't really
think or weren't paying enough attention to this issue.
DR. GORMAN: I think the focus of what I would hope would be a patient package piece of information
and not the mandated, got to be given out, is that just because it just goes on your skin doesn't mean it doesn't have effects
on the rest of your body because I think that would apply for a lot of dermatological products besides just steroids. It would
then focus on the fact that this has systemic effects __ excuse me __ has potential systemic effects.
DR. WILKIN: I think Dr. Schneider has made the point on several occasions, and I'd just like probably a highly reductive
reiteration. So one of the key messages to our group is that the topical delivery is the part that isn't getting through to
clinicians, anesthesiologists, internists, folks in emergency rooms, perhaps even pediatricians and dermatologists that topically
applied products can have systemic effects. That seems to be a theme that would go beyond corticosteroids that we need to
think about for some of our other products as well.
Like I said this is a very small part of the meeting, but I found it very disturbing that doctors do not read the inserts,
and admit probably most parents dont. And that only 1% to 30% of adverse effects of medications are reported. So this very
much applies to Lindane, as well as any other medication applied to the skin.
