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Lindane News
Center for Disease Control (CDC) Lindane should not be used to treat premature infants, persons with a seizure disorder, women
who are pregnant or breast-feeding, persons who have very irritated skin or sores where the lindane will be applied, infants,
children, the elderly, and persons who weigh less than 110 pounds
Researchers Identify Specific Pesticide Linked To Parkinsons Disease-Lindane
Governments unite to step-up reduction on global DDT reliance and add nine new chemicals under international treaty
Lindane added to dirty dozen at Stockholm Convention
Experts Mull Global Ban On Commercial Chemicals Stockholm Convention
Lindane, Community Health and Human Rights
Edmonton MP calls for global phase-out of chemical pesticide (Lindane)
Michigan paper letter to the editor and response by a concerned parent
Tribal Leaders, Doctors, Parents and Advocates Call for New US Position on Pharmaceutical Uses of the Pesticide Lindane
In a letter to Secretary of State Hillary Clinton and Acting Commissioner of the Food and Drug Administration Joshua
Sharfstein, a coalition of groups called on the agency leaders to support listing of lindane under the international treaty
without exemption for lotions and shampoos ("pharmaceutical uses"). The letter also
urged FDA to "take definitive action in ending pharmaceutical use of lindane domestically, as has already been accomplished
in California."
Michigan House Great Lakes & Environment Committee advances Lindane bill !!!
Health, medical and environmental organizations praised the Michigan House Great Lakes & Environment Committee for
overwhelmingly advancing legislation (HB 4402) that protects children’s health.
In a bipartisan vote of 11-3,
the committee approved restrictions on the use of lindane, a pesticide used in pharmaceuticals for the treatment of lice and
scabies.
The full House passed an identical measure by a more than 2-1 margin in 2008.
In 2003, the U.S. Food
and Drug Administration issued a public health advisory for lindane. The agency recommended that lindane products be used
with caution for infants, children, the elderly and those who weigh less than 110 pounds because they might be at risk of
serious neurotoxicity.
In 2006, lindane was voluntarily withdrawn from agricultural uses.
Lindane also is no
longer used in the United States in the military or on livestock.
HB 4402 would require that lindane be used only under
a physician’s direct supervision.
The Michigan Department of Community Health does not recommend lindane use
for head lice or scabies and supports the legislation, according to the Michigan Network for Children’s Environmental
Health.
Parents want shampoo banned
Clean Water Action-Michigan
Lindane "An organochlorine insecticide that has been used as a pediculicide and a scabicide. It has been shown to cause cancer"
Despite Love Canals Lessons, Schoolchildren are Still At Risk
Two infant deaths from cough medicine
Reminder to healthcare providers and parents concerning the blackbox warning on lindane
Breaking News ! Lindane bill moving ahead in Michigan.
Michigan bill passes 4/15/08 !!!
Doctors want to phase out lindane
Canada-Parents told to avoid lindane-laced lice shampoo
"We consider this outcome an unqualified victory,'' Garfield said. "From the outset,
we viewed Morton Grove's lawsuit as a baseless tactic designed to stifle public debate.''
Ecology Center's lindane suit settled
PHI Pharmacy stopped selling lindane
Next time just shave your head...at least you'll live through it..
Group seeks ban on lindane
FDA-Lindane ads misleading
FDA cites risk of lindane
States may restict lice "treatment"
Click here to read Warning letter sent to Morton Grove Phamaceuticals/Alliant from the FDA about deceptive/misleading/and
potentially dangerous advertising
After reading the above information by clicking on the link about the
warning letter, you just have to see what Morton Grove Pharma still has on their website lindane.com about advocates who warn
about the dangers of lindane.
Groups seeking to ban the medical use of lindane have done a disservice to the public by spreading misleading information, often presented
out of context, in the news media, on the Internet, and elsewhere about the risks and benefits of lindane. Repeatedly, their
petitions to ban lindane medications have been rejected and determined to be without merit by scientific and medical experts
working with the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA).
Can you believe this?!? They say groups are doing a disservice by
spreading misleading information, when their websites and newsletters sent out to school nurses were not only misleading,
but downright dangerous !!!!!!!!!!
For immediate release: January 15, 2007 Pesticide Action Network North
America
49 Powell Street, Ste 500, San Francisco, CA 94102
Contact: Steve Scholl-Buckwald, 415-981-1771; cell 415-203-4455
FDA slaps Morton Grove for lindane shampoo advertising
Agency responds to citizen complaints, chastises company for
misleading claims
The U.S. Food and Drug Administration (FDA) has issued a pointed
warning letter to Morton Grove Pharmaceuticals of
Illinois, charging
that the company's advertising for its lindane products is misleading.
FDA chastises Morton Grove's
CEO, Mr. Kurt Orlofski, for making false claims of lindane's effectiveness for the treatment of headlice, and for omitting
and/or minimizing important risk information for
children, "including crucial facts about potentially fatal risks
associated
with the use of Lindane Shampoo in this vulnerable
population."
"Many months ago I filed a formal complaint to the FDA regarding the way Morton Grove and Alliant were advertising lindane
on their
websites, along with a misleading handout sent to many nurses at
schools across the country called 'The Nitpicking
News'," says New
York activist Pamela LaBrake. "The FDA has taken action!" LaBrake founded Parents Against Lindane after
her son was adversely affected by a lindane treatment. Her organization educates parents about the dangers of lindane shampoo
and has joined other advocates in pressing for a ban of pharmaceutical uses of lindane in New York.
Lindane's use in shampoos and lotions has been banned in the state of California since 2002. A recent study in Environmental
Health
Perspectives (EHP) suggests that the state's lindane ban has not
resulted in an increase of lice or scabies
outbreaks, and health
professionals are using alternative products. Lindane is considered by scientists to be one of the
least effective ways to control headlice.
Combing wet hair with specially designed lice combs has been found to be one
of the safest and most effective lice treatments.
"The medical community has recognized that lindane is less effective and more toxic than alternatives since the 1980s,"
says Dr. Mark
Miller, one the EHP study authors and Director of the Pediatric
Environmental Health Specialty Unit
at University of California, San
Francisco. "We now have six years of experience in California without it, and no one
seems to have noticed."
Lindane has been banned in more than 50 countries, including recent bans of all uses in Mexico and Chile. It is a persistent
chemical that
is currently under consideration for a global ban under the Stockholm Convention for Persistent Organic
Pollutants. EPA banned all
agricultural uses of lindane in the U.S. in August 2006.
"We're pleased FDA is finally demanding that Morton Grove stop these false and misleading claims that put children at risk,"
says Kristin Schafer, Campaigns Director for Pesticide Action Network North America. "It makes no sense - this company is
still aggressively pushing a product known to be dangerous to children, even when governments around the world are targeting
lindane for a global ban."
The government warning comes as Morton Grove continues to pursue SLAPP actions - lawsuits intended to silence one's critics
- against the
Ecology Center of Ann Arbor, Michigan and the National Pediculosis Association for publicizing information
about the health effects of
lindane.
FDA's December 13, 2007 letter called on Morton Grove to respond with a "comprehensive plan of action to disseminate truthful,
non-
misleading, and complete corrective messages about the issues
discussed in this letter" no later than December
31, 2007. As of this
writing, one of Morton Grove's most prominent lindane websites,
lindane.com ("Lindane Facts:
The truth about lindane"), continues to
make safety and efficacy claims similar to those cited as misleading
and dangerous
in FDA's warning letter. There is no public notice that the company has responded to FDA.
The Adverse Event Reporting System
In a search done in May, 2002 the AERS database listed 488 adverse
events reported with lindane use.
The most prevalent was drug ineffective 111.
Followed by convulsions 65, dermatitis 34 and dizziness 29.
Fifteen additional reports described grand mal convulsions.
Other common adverse events listed alopecia, headache Nos, Urticaria NOS,
Pain Nos, Paraesthesia, Vomiting Nos, Overdose Nos, Grand Mal Convulsion, Pruritus Nos, Dyspnoea Nos, Diarrhea Nos, Pyrexia,
Medication Error, Myalgia, Thinking Abnormal and Tremor.
A detailed review of 74 serious cases described 15 deaths, 46 hospitalizations,
seven life threatening and six cases of congenital anomalies.
Breaking News!!!!!
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Judge nixes suit by drug maker
Ecology Center, doctors sued for criticizing chemical used to kill lice
Thursday, May 10, 2007
BY TRACY DAVIS News Staff Reporter
A federal judge has dismissed a pharmaceutical company's lawsuit against the Ecology Center and two Michigan pediatricians.
The lawsuit, brought last year after a campaign in Michigan to ban a key ingredient in two of the company's products, alleged
the center was guilty of defamation for "wrongfully attacking'' the chemical.
In the opinion, issued last week, U.S. District Court Judge Elaine Bucklo, of the Northern District of Illinois, found
that the court lacked jurisdiction.
Leaders at the Ann Arbor-based Ecology Center applauded the judge's decision.
"From the beginning we thought that the ... lawsuit was simply meant to stifle us and keep us from advocating for legislative
action to ban this very toxic chemical,'' said Mike Garfield, director of the non-profit center. "Many individuals and organizations
do not have the resources to defend themselves against harassment suits like this.''
Attempts to reach representatives with Illinois-based Morton Grove Pharmaceuticals were unsuccessful Wednesday.
The chemical in question is lindane, which the company uses in a shampoo and lotion to treat lice or scabies. It's approved
by the U.S. Food and Drug Administration as a "second-line'' medication for infestations, meaning it can be used after other
treatments have failed.
The Ecology Center and the doctors were supporting a bill in the Michigan Legislature to phase out remaining pharmaceutical
uses of lindane, which some environmental and public health advocates have argued is unsafe. The U.S. Environmental Protection
Agency has banned all environmental and agricultural applications of lindane.
The bill has been reintroduced and is now in the Michigan House's health policy committee. |
Alpharetta, GA June 1, 2005 Alliant Pharmaceuticals, Inc. a pediatric specialty pharmaceutical company,
and Morton Grove Pharmaceuticals, Inc. today announced that they have completed an agreement under which Alliant Pharmaceuticals
has in-licensed from Morton Grove, the exclusive sales and marketing rights in the United States for Lindane Shampoo and Lindane
Lotion.
So Alliant who "specializes" in Pediatric medications
is given the license to market and sell lindane which is to be used with caution on anyone under 110 lbs. The key word here
is pediatric, as we all know that headlice mainly affects children in the age range of 3 to 12 years of age whom most would
be under 110 lbs.
This is on Alliant's website,
stating that Lindane is an effective treatment for headlice . Any lay person or health proffessional can do a search on the
web, including pub med, and find lindane is the least effective and most toxic.
ALLIANT Pharmaceuticals, Inc.
Lindane Shampoo is a fast and effective treatment for head lice. Recommended
treatment time is just FOUR MINUTES. Lindane Shampoo has shown an efficacy rate of 92% at seven days and 85% at fourteen days
(1). Lindane Shampoo is indicated for the treatment of head lice, crab lice, and their ova in patients who cannot
tolerate other approved therapies, or who have failed treatment with other therapies. Please see black box warning and other
important safety information by clicking on the link below.
Alliant uses one study from 1986, over 20 years ago, since then there
have been numerous studies to show lindane is the least effective and most toxic.1. Brandenburg K, Deinard AS, DiNapoli J,
et al. 1% permethrin cream rinse vs 1% lindane shampoo in treating Pediculosis captitis. Am J Dis Child. 1986;140(9):894-896
Below are just some examples of the ineffectiveness of Lindane, do a search yourself, you'll be reading
for hours.
Source: University of Texas at Austin, School of Nursing, Family Nurse
Practitioner Program. Recommendations for the treatment of pediculosis capitis (head lice) in children.
Lindane 1% Shampoo (generic only): Lindane
is the least effective pediculicide and is not ovicidal [8] It is neurotoxic to lice and people and is absorbed slowly
through skin, especially face, neck, scalp, scrotum, axillae and damaged skin. It collects in body fat, is metabolized by
the liver and excreted in feces and urine. It is secreted in human milk [9,10] It has low toxicity in humans with indicated
application time of 4 minutes [8], Problems with resistance have lead to increased application times in effort to increase
efficacy. This results in increased percutaneous absorption and toxic effects on the central nervous system [8]. Contraindicated
in children less than 2 years of age, pregnant and nursing mothers and people with known seizure disorders [10]. Lindane 1%
shampoo is banned in California due to environmental problems with lindane in sewage effluent [8].
Pesticide Action Network North America (PANNA).
Scientists report that lindane
is currently among the least effective means to control lice and scabies. In a recent article, researchers studying
the effectiveness of lindane for lice control "strongly recommend its removal from the market." In an informal survey conducted
by the California chapter of the American Academy for Pediatrics, doctors report that they had stopped using lindane even
before the California ban because of "low efficacy and high toxicity."
University of California
In the past a popular product for the control of head lice was a product
called Kwell, which contains the insecticide lindane. Lindane has been associated with a variety of adverse reactions suffered
both by people being treated and by people applying the treatment. It is also a troublesome pollutant of wastewater and requires
special treatment to be removed. While lindane is still available by prescription,
pyrethrin and permethrin are safer, more effective, and less polluting than lindane.
University of Nebraska Cooperative Extension
Kwell: One shampoo product that is only available by prescription is Kwell®®.
It has been used in the U.S. for lice for about 50 years. Head lice resistance to
lindane, the active ingredient in Kwell, has been reported in many parts of the world, including the U.S. This product is
less effective than most of the other head lice treatments. It is available only by prescription because it is more
hazardous. Kwell should be used with caution——neurotoxic reactions, carcinogenicity in lab animals and blood disorders
have been reported as a result of the normal use of lindane shampoos.
Comparative In Vitro Pediculicidal Efficacy of Treatments in a Resistant
Head Lice Population in the United States Terri L. Meinking, BA; Lidia Serrano; Bruce Hard, MA; Pamela Entzel, JD, MPH; Glendene
Lemard, MA; Elisabeth Rivera; Maria Elena Villar, MPH Results Two prescription products,
Ovide lotion (0.5% malathion) and 1% lindane shampoo, were ranked in the same order as in 2 previous studies (first and last,
respectively). The order of effectiveness from most to least effective was as follows: Ovide lotion, A-200 shampoo
(a natural pyrethrin product synergized with piperonyl butoxide), undiluted Nix (1% permethrin), diluted Nix, RID (a natural
pyrethrin product synergized with piperonyl butoxide), and 1% lindane shampoo.
American Journal of Pharmaceutical Education
Lindane. Lindane is a cyclodiene pesticide which is also the most toxic
pediculicide available(6). It kills very slowly; as the lice die they twitch on the scalp, producing an uncomfortable sensation
for the patient.
Lindane has several other attributes
that argue against its use. It does not kill all ova (its ovicidal activity is only 45-70 percent), allowing viable ova to
survive and prolonging the infestation. Its widespread use has allowed resistance to develop(4,7).
Lindane also carries the risk of human toxicity. Its primary deposition
occurs in the brain's white matter(8). Severe adverse reactions have been reported, including seizures, which may occur as
uncontrolled motor activity lasting for 48 hours or longer(7,8). The risk of this is enhanced when the patient bathes before
treatment, has dermatitis, or excessively thin skin. Aplastic anemia and renal disorders also may occur(7).
Kwell was a major trade name for lindane for many years, but it has been
discontinued. However, generic lindane products are still available. The pharmacist dispensing the product should wear gloves
while pouring it to prevent unintended contact. Patients should be warned not to use more than two ounces of lindane shampoo
per application and to wear gloves while using the shampoo. Since oils enhance absorption, the patient must avoid application
of any oil to the hair for several days prior to lindane use. The lather must not touch any areas other than the hair. Lindane
should only be reapplied if the physician has advised the patient to do so, and it must not touch broken skin.
I was the pharmacist expert at a roundtable on lice treatment in Boston
several years ago. One of the attendees was a structural pest eradication specialist. He reacted in astonishment as I described
the dangers of using lindane in humans. When his turn came to speak, he stressed that lindane has been prohibited in structural
use for many years due to toxicity. This should cause the pharmacist to question further any application to humans.
Although many of the adverse reactions from lindane were a result of misuse,
it is prudent to take great care with a product whose misuse can be deadly. In light of the possibility of serious toxicity
and the potential for resistant lice, pharmacists should not recommend that physicians prescribe lindane. Unfortunately, the
patient may only be able to obtain medication for head lice by relying on a third-party payer such as the state. If reimbursement
is limited to prescription items, both patients and physicians turn to lindane, the only prescription lice pesticide. Once
again, the pharmacist may choose to intervene, urging the patient to choose a lice treatment based on safety to the patient
rather than only on economic criteria.Clinical update on resistance and treatment of Pediculosis capitis. Meinking TL.
The efficacy of over-the-counter
pyrethrin products had declined significantly, and lindane, another prescription product, was least effective of all products
tested both in the 1980s and in more recent studies.
Scientists
report that lindane is currently among the least effective means to control lice and scabies. In a recent article, researchers
studying the effectiveness of lindane for lice control "strongly recommend its removal from the market." In an informal
survey conducted by the California chapter of the American Academy for Pediatrics, doctors report that they had stopped using
lindane even before the California ban because of "low efficacy and high toxicity." PANNA
Lindane has
little if any role in the treatment of head lice. Studies have documented its poor pediculicidal and ovicidal activity, and
it is potentially neurotoxicby Edward A. Bell, PharmD, BCPS Special to Infectious Diseases in Children
Lindane also had the slowest pediculicidal and
least effective ovicidal activity compared with three other approved
pediculicides (i.e., 1% permethrin, 0.3% pyrethrin, and 0.5% malathion)Centers for Disease Control and Prevention
6. Isn’’t 1% Lindane that the doctor prescribes
the most effective? No. Lindane is no longer the drug of choice. It may be that lice
are becoming resistant to this product. Recent studies show that 1% Lindane (i.e., Quell®®, Scabbing®®) is the least effective
at killing lice. SONOMA COUNTY HEALTH DEPARTMENT SERVICES
Lindane is an organochloride marketed in a 1% concentration
shampoo. This agent has been used to treat head lice for more than 50 years but recently came under increased scrutiny because
of its toxic adverse effects. Lindane has neurotoxic properties similar to those of DDT, killing lice by overstimulation of
the parasite’’s central nervous system.5 Although lindane was once
considered a primary treatment of head lice, poor efficacy and serious adverse events have resulted in use restrictions. Resistance
to lindane is widespread and has resulted in decreased efficacy in the United States. In a recent comparison of lindane, malathion,
pyrethrin, and permethrin used to treat both treatment-sensitive and treatment-resistant lice collected from a patient population
in Florida, 1% lindane was the slowest and least effective product. killing no lice after 10 minutes, the recommended
application time for lindane shampoo. After 3 hours of exposure, only 17% of lice were dead.Mayo Clin Proc. 2004;
As the studies above indicate, lindane resistance is so prevalent that
this product has become virtually useless in the United States. Indeed, 3 hours of 1% lindane shampoo application killed only
17% of treated lice -- an unacceptable result, especially in light of the fact that such lengthy application is neither feasible
nor safe (due to the potential for increased percutaneous absorption causing CNS toxicity).
Meinking TL, Serrano L, Hard B, et al.
Archives of Dermatology. 2002;138(2):220-224
BMJ 1995;311:604-608 (2 September)
General practice
Systematic review of clinical efficacy of topical treatments for
head lice
We also made an intrastudy comparison of the two largest trials.22 24 Both trials were of high quality and compared single applications of
permethrin 1% creme rinse with lindane 1% shampoo. The odds ratio of treatment failure for lindane versus permethrin
was 15.11 (95% confidence interval 4.60 to 49.62) in one study22 and was 15.28 (5.13 to 45.52) in the second study.24 After performing a Breslow-Day test for homogeneity of odds ratios (P=0.99),
we obtained the Mantel-Haenszel summary odds ratio of 15.18 (7.99 to 28.84). Hence, the risk of treatment failure was likely to be at least eight times higher with lindane than with
permethrin.
Conclusions: Only for permethrin has sufficient evidence
been published to show efficacy. Less expensive treatments such as malathion and carbaryl need more
evidence of efficacy. Lindane and the natural pyrethrines are not sufficiently
effective to justify their use.
Although this says lindane was not used according to directions, it DOES state only one dose applied. Even with blackbox
warnings lindane is STILL killing people.
Sudakin DL.
Department of Environmental and Molecular Toxicology, Oregon State University, Corvallis.
Lindane lotion, approved by the US Food and Drug Administration (FDA) for treatment of scabies and lice,
poses risks of serious adverse effects on the nervous system.
In 2003, the FDA issued a public health advisory for lindane products, emphasizing the importance
of compliance with labeling instructions. The author presents a case in which a fatal
outcome followed a single dermal application of lindane.
The product was not applied according to the labeling instructions, and the 66-year-old man rapidly developed
hypoxemia, seizures, respiratory acidosis, and hypotension. The final diagnosis at autopsy was hypoxic ischemic encephalopathy
from lindane. This case is consistent with other reports of severe neurological outcomes from pharmaceutical use of lindane.
These factors suggest a need for the FDA to reassess whether the risks of lindane have been effectively communicated to healthcare
providers.
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