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PARENTS AGAINST LINDANE |
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The safest alternative to lindane
Found this video about lindane on utube, it's excellent!! Used with permission of author.
August 5, 2009 To: Andrew Haffer PharmD FDA/CDER/OMP/DDMAC 5901-B Ammendale Road Beltsville, MD 20705 fax-301-847-8444 From: Pamela LaBrake 349 Schenectady St. Schenectady, NY 12307 I am writing a formal complaint against Morton Grove Pharmaceuticals/
Wockhardt for their continued advertising of lindane shampoo and lotion, this after the FDA sent a warning letter to them
December of 2007. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm054144.pdf Morton Grove continues to promote lindane on its website lindane.com http://www.lindane.com/?gclid=CImLo-7hjJwCFcZM5Qod9kw-ZA with no mention of black box warnings on its advertised link or the web
page people are brought to. Anyone doing a search for lindane on search engines such as Google and yahoo are shown a sponsored
link with highlight saying the following Morton Grove Pharmaceuticals/Wockhardt are in fact ignoring the very warning
sent to them by the FDA. The website makes no mention of the warning letter, as per instructed by the FDA. They are lobbying for their product, claiming on the first page and others
that the EPA supports second line use of lindane therapies, when in fact the link they provide is information before the black
box was put into effect. In fact the very statement that the FDA, EPA and CDC all support the second
line use of lindane is erroneous in itself, lindane is an FDA approved medication, but NO government agency supports the use
of any medication. The FDA has the following information concerning black box warnings and
advertising: Boxed Warning Drugs that have special problems, particularly ones that may lead to death
or serious injury, may have this warning information displayed within a box in the prescribing information. This is often referred to as a "boxed" or "black box" warning. Drugs that have such boxed warnings are not permitted to
have reminder ads. The promotional materials of drug products with boxed warnings must present
these serious risks in a prominent manner Any advertising of products that carry black box labels must also include
the black box warning information as part of the advertisement On MG's lindane.com page information and fact checker they compare the safety
of Lindane compared to Tylenol : In striking contrast, acetaminophen (e.g., the active ingredient in TylenolŪ) has been reported
to cause roughly 500 deaths and over 50,000 emergency room admissions every year, yet it remains available without prescription.
Lindane.com asks visitors to read their medical and scientific opinions.
Many of these opinions are addressed to state governments that are considering restricting the use of Lindane. They are NOT
opinions of medical experts on the safe way to treat head lice, but a lobbying tool. What is troubling is these medical opinions are written by those whose
specialty is the pediatric population. The letter from Joceyln Elders is used by Morton Grove/Wockhardt to target
the pediatric population, another violation of the warning letter sent to MGP. Here is a direct quote from her letter: “I served as a board-certified pediatrician and in the sub-specialty
of Pediatric Endocrinology on the UAMS faculty and medical director for long-term care facility for more than 35 years. I/we
treated many patients infected with lice and Scabies-causing mites with topical medical grade Lindane Lotion or Shampoo. Most
of these patients had failed to respond to over-the-counter medications or home remedies.” “Since head lice can
be a major health problem in children, especially in urban environments, it is critical to have a safe and effective alternative
medication.” And yet another from Adelaide A. Hebert, MD Professor of Dermatology “As the current President of the Society for Pediatric Dermatology,
I can strongly attest to the value of Lindane for pediatric patients who suffer from scabies and lice.” In addition sales representatives from Wockhardt are advertising that
they are promoting lindane to pediatricians. Building on the “branded generic” Lindane business, the Company
has formed a Pediatric division with 30 sales representatives to successfully launch Bromfed DM for cough & cold treatment.
In 2009, the Company has plan to launch another 5-6 branded generic products. http://www.wockhardt.com/pdf1/2008/ManagementDiscussionandAnalysisReport.pdf I ask that you take a good look at lindane.com and you will at once realize
that the black box warnings are not displayed on their sponsored link or the web page consumers are sent to. They are in violation
of the warning letter and subject to further action by the FDA as stated in the conclusion of the warning letter: “The violations discussed in this letter do not necessarily constitute
an exhaustive list. It is your responsibility to ensure that all your promotional materials comply with each applicable requirement
of the Act and FDA implementing regulations. Failure to correct the violations discussed above may result in FDA regulatory
action, including seizure or injunction, without further notice.” Lindane.com which is owned by Morton Grove, a pharmaceutical company,
should not be used as a lobbying site. First of all as I stated previously the warnings concerning lindane are not displayed
on its sponsored link, or its main page. In fact anyone would have to look carefully through the pages and pages on the site
to find the black box warning. The three doctors who have letters under medical and scientific opinions are all in the pediatric
field. All of the letters posted are written to state politicians, which has
no place on a pharmaceutical web page that should be educating patients on the benefits and risks of their product. They even have a page devoted to clarifications in a lawsuit they were
involved in not too long ago, against the Ann Arbor Ecology Center, again this does not belong on a site promoting a pharmaceutical
product. As Morton Grove is in non compliance of the warning letter from December
2007, I ask the FDA to take appropriate action. If you have any questions I can be reached at 518-346-7190. I will be awaiting your response. Sincerely, Mrs. Pamela LaBrake 349 Schenectady Street Schenectady, NY 12307 (2009-05-12) Parents Against Lindane This week at the Stockholm Convention, lindane was added to a list of harmful chemicals and toxins that affect our
health and the environment.
Lindane will be banned !!! GENEVA (AFP)--Nine chemicals, including headlice treatment lindane, have been added to a list of poisonous substances that
are to be eliminated under the Stockholm Convention, the U.N. Environment Program said Saturday. More than 160 signatory states of the convention targeting hazardous substances that can kill or are seriously harmful
to health, added the chemicals to the existing list of 12 after a week-long meeting in Geneva. "The tremendous impact of these substances on human health and the environment has been acknowledged today by adding nine
new chemicals to the Convention," said U.N. Under-Secretary General Achim Steiner in a statement. "This shift reflects international concern on the need to reduce and eventually eliminate such substances throughout the
global community." The nine chemicals that member states have now committed to eliminate are a follows: - Lindane - used in treatment of headlice and scabies, and in insecticides - Alpha hexachlorocyclohexane - a byproduct of lindane - Beta hexachlorocyclohexane - a byproduct of lindane - Hexabromodiphenyl ether and heptabromodiphenyl ether - used in flame retardants - Tetrabromodiphenyl ether and pentabromodiphenyl ether - used in flame retardants - Chlordecone - used in agricultural pesticides - Hexabromobiphenyl - used in flame retardants - Pentachlorobenzene - used in fungicides, flame retardants - Perfluorooctane sulfonic acid, its salts and perfluorooctane sulfonyl fluoride - used in electric and electronic parts,
photo imaging, textiles
Lindane added to the list of the Stockholm Convention on Persistent Organic Pollutants
VERY IMPORTANT FOR PARENTS If given a prescription for lindane, tell the doctor you want a safer treatment for your child. There are non-toxic
over the counter shampoos and lice combs. FDA Blackboxes Lindane with the following warnings: Infants, children, the elderly, and individuals with other skin conditions and those who weigh 110 lbs
(50 kg) may be at greater risk of serious neurotoxicity. (See Pediatric Use andGeriatric Use.) Animal studies have shown increased
susceptibility to neurologic adverse events in younger animals. Children have a larger body surface area to volume ratio that
may result in a proportionately larger systemic exposure. Careful consideration should be given before prescribing Lindane Lotion to patients with conditions that may
increase the risk of seizure, such as HIV infection, history of head trauma or a prior seizure, CNS tumor, the presence of
severe hepatic cirrhosis, excessive use of alcohol, abrupt withdrawal from alcohol or sedatives, as well as concomitant use
of medications known to lower seizure threshold. (See PRECAUTIONS: Drug Interactions.) FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH PEDIATRIC ADVISORY SUBCOMMITTEE OF
THE ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE 8:06 a.m. Wednesday, October 29, 2003 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. When reading the Reported Adverse Events from Lindane keep in mind
that only 1% to 30% are reported. So the 255 reports that were sent in are only a sample of the thousands that should have
been. And this report covers less than nine years. Lindane Adverse Event Reporting System Nov. 1, 1997 to June 20, 2006 Total Safety Reports - 255 Total Reactions -710 Total Death Outcomes by Case- 13 The Top Thirty Reactions were as follows: Drug Ineffective - 71 Medication Error - 22 Convulsion - 20 Pruritus - 18 Drug Toxicity - 16 Dizziness - 14 Formication - 14 Hair Growth Abnormal - 13 Headache - 13 Alopecia - 12 Laceration - 11 Burning Sensation - 10 Nausea - 10 Dermatitis - 9 Vomiting - 9 Pain in Extremity - 9 Blister - 8 Condition Aggravated - 8 Decrease Appetite - 7 Pain - 7 Drug Effect Decreased - 7 Dyspnoea - 6 Paraesthesia - 6 Swelling - 6 Fatigue - 6 Arthralgia - 5 Myalgia - 5 Rash - 5 Urticaria - 5 Nervous System Disorder - 5 Lice are resistant to insecticides due to overuse, click here to read story and watch video
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