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November 2009
I recently picked up some *Hartz Ultra Guard Pro* at the grocery store to deal with fleas on my one year old Jindo. I chose the right weight size for my dog (31-60 lbs) and took
it home. I applied per the instructions (directly to skin along the spine of the dog). Within 4 hours I noticed that my dog's jaw was chattering uncontrolably, but I didn't think about the flea & tick drops. The next day my dog had trouble walking as his hind legs were becoming lame and he even was losing bladder control as he peed himself while he was laying next to me. At this point I looked up the *Hartz* product online and read about the 'wonderful' side effects that it can cause. I have not used anything on him or taken him around anything else that could be a cause of this, as he is an indoor dog. I immediately washed him off so hopefully the effects will only be temporary.
I will never give another cent to *Hartz* or any of its affiliates.
Andrew 11/2/09
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(Below is email that I sent to Kimberly Nesci at the EPA on 11/3/09)
Dear Ms. Nesci,
Could you please give me an update on your investigation of spot-on flea and tick products? When do you plan to post the results on your website? At what point in your investigation do you plan to seek public comment on this issue?
Sincerely,
James TerBush
Website Administrator
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(Below is a follow-up to a message posted by Debra on 9/27/09)
Hello James,
I emailed you about six weeks ago regarding my Italian Greyhound Ally and her illness that I believe began after I applied Frontline PLUS to her around the end of August. I have wanted to email again before now but I have been dealing with her declining health and a new job as a teacher that has taken over my life. I am very sad today. This morning my precious Ally passed away after a very short battle with hemangiosarcoma. About two weeks ago, she had an ultrasound at my vet and it revealed multiple masses in her spleen, one in her liver, and one in her heart. My dog was only eight years old. Five months prior to this ultrasound, she had another abdominal ultrasound and none of
these masses were present. The symptoms she developed after giving her Frontline PLUS were also not there either. When I emailed you last, I thought she had AIHA because her blood count was very low and she was anemic. She had another episode like this right before we had the ultrasound done a couple of weeks ago and this time
her blood count was even lower. Each time she lost more ground in terms of her quality
of life and ability to eat and move about the house. It has only been about 9 weeks since she had the first dose of Frontline on August 24th. I gave her one more dose on Sept 24th. My vet says her illness was not caused by Frontline and that we will never know what caused her to get this very aggressive form of cancer which is not typically seen in her breed of dog. Hemangiosarcoma in the heart is rare in IGs.
Please tell me if you know of other cases of this cancer related to Frontline or other flea/tick meds. If you think I have a case, I am going to ask Merial to reimburse my medical expenses which have been significant in the last two months, but pale in comparison to the sadness and devastation I have experienced watching my beautiful dog suffer and die like this.
Thank you,
Debra 11/3/09
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We were out of town visiting on a farm when I found a tick on one of my 70 + pound dobermans. Our tick and flea product normally used is Vectra, very expensive but very effective. We just wanted to protect the dogs short term until we were back home and could give the Vectra so I purchased SentryPro XFC from Petsmart in Dothan, Alabama.
Our dogs had the same reactions as we have now seen posted on the internet, extreme itching and drooling with saliva. The SentryPro was given Saturady afternoon October 31, 2009 and today, November 4th, they continue to have itching problems. We called the product hotline and followed the advice given to bath the dogs. The dogs have been bathed again since we arrived back home and are being given an antihistamine.
I will report this to Petsmart and the FDA on the adverse drug reaction forms I found on the internet. This is a product that should have been pulled from the market a long time ago! If only I had internet contact at my mother's farm and had read this information prior to giving this drug to my dogs. They would have been better off without it.
Kathy 11/4/09
South Carolina
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I understand your concern and dismay, but perhaps some animals are allergic to the ingredients. I have used Bio Spot for over 15 years for all the dogs I have had during
that time - and there have been many. I have also used it on rescue animals that were adopted by others. I started using their cat product over a year ago. All in all I have used Bio Spot on more than 15 dogs and 30 cats and repeated the application at 4-6 week intervals. Never once, not 1 time, have I ever had any adverse reaction whatsoever. Absolutely NO reactions at all, in fact except that I do not have a flea or tick problem.
Just thought I'd like to let you know that there are many success stories with this product.
Karen 11/10/09
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This post is in response to "Karen's" post on November 10, 2009:
Karen, I sincerely appreciate your post and I'm relieved that you've not yet had a problem with BioSpot. However--and I hope you'll accept this advice in the spirit intended--it is not at all unusual to use these over the counter topical pesticide products once, twice, or more without a problem (actually, with what appears to be success) and then have the worst possible scenario take place. These products have a history of blowing up an animal's neurological system without warning. I know this because it happened to us.
We had a perfectly healthy six year old Scottish Terrier that had periodic applications without any apparent problem. The next application resulted in his death. It was a terrible, tortuous, agonizing and painful death that took three days to complete. Our two attending veterinarians have written medical opinions and participated in conference calls with me and the manufacturer--Hartz Mountain--supporting the fact that it was their product that killed our pet. Don't take my word for it. Do some research. Look at reputable sources like this site or the Humane Society of the United States or Natural Resources Defense Council or many others. It was an eye opener for me. I didn't know how lethal these products are until it was too late. The documented history of damage from BioSpot, Hartz, Sergeant's and others is breathtaking. The lack of responsibility, care and concern from the manufacturers is reprehensible.
Again, Karen, I really do appreciate your post. I cannot tell you how happy I am that you haven't had to endure the same experience my family went through with the death of our pet. No animal should have to die the way ours did and no family should endure the sense of loss and devastation. Please be careful as you consider treating your pets
and companion animals in the future. Thanks again for your post.
Rich 11/10/09
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When my family moved this last summer, we got a house with a flea problem. After
trying every natural flea treatment I could find, including the apple cider vinegar bath,
my cat was still suffering with fleas. We finally broke down and decided to use Frontline Plus for cats. Of course, my cat was unhappy with this, but nothing happened initially.
After a few days she had a seizure. We did not correlate the seizure and the Frontline
at first, after all she is old (14), very obese, and had the stress of moving and losing a family member to marriage. Over the next month she had several more seizures, and we could not and can not afford to take her to the vet. (This is a painful and agonizing fact). She has been having seizures for the three months we have been putting Frontline on her.
I noticed that she has several seizures the week after application, they tapper off over the next two weeks, and she does not have any the last week of the month. When I noticed this I stopped applying the Frontline. Then, last night I was watching the local news channel and saw a report on the dangers of spot-on treatments. This confirmed
my belief that Frontline caused my cat's seizures.
I am hoping and praying that these seizures are temporary and have/will not cause any lasting health problems.
By the way she still has fleas after 3 months on Frontline.
Elizabeth 11/11/09
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Re: VECTRA 3D
In October we wrote to describe what we thought were "Jenna's" reactions to Vectra
3D. After many tests and hours in the vet clinic, Jenna was diagnosed with a frontal
brain tumor after an MRI. This is no doubt the cause of her seizures - not Vectra 3D
as we suspected. We promised to follow-up after we knew more and wanted to ensure we provided accurate information to this community. Jenna is doing well on her Phenobarb/steroids to control seizures and decrease swelling. The vet's give our Dear Jenna about 60 days without radiation. They also confirmed the main ingredient in Vectra 3D is VERY toxic to animals and Frontline is recommended because it is not systemic (absorbed into the pet's system). This is a great website dedicated to the
well being of our furry friends - keep the conversations and information flowing!
Richard 11/11/09
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(Below is email that I received from Kimberly Nesci at the EPA on 11/12/09)
Dear Mr. TerBush,
Thank you for your email on November 3, 2009. We are appreciative of
the level of public interest in this topic as we are conducting our
review. The following is a response to your questions:
Investigation
The Agency has prepared draft written reviews of the enhanced reporting
information received. These draft reviews are currently being jointly
peer reviewed by authorities from the Food and Drug Administration’s
Center for Veterinary Medicine as well as Canada’s Pest Management
Regulatory Agency. The Agency expects to release its formal analysis to
the public after the completion of the technical peer review and
finalization of the reviews. The Agency is still on schedule to release
its analysis in the fall of this year; please continue to check our web
page on pet spot-on products for updates:
Please note that the Agency's formal review does not yet include final
risk mitigation conclusions. As noted in my previous emails, the Agency
will implement any regulatory decisions necessary to ensure that the pet
spot-on products perform their intended functions without posing
unreasonable risks to humans, animals, or the environment. These
important public health decisions cannot be made until after the formal
technical review has been completed. In addition, to ensure full
transparency, the Agency expects to obtain public input on any proposed
risk mitigation before making a final decision.
Public Comment
The Agency is committed to transparency and public participation in its
regulatory decision-making processes. This commitment was exemplified on
October 1, 2009, when the Office of Pesticide Programs began a formal
process by which risk assessments and proposed regulatory decisions will
be made available in the public docket for comment. . Following the
30-day public comment periods, EPA will publish its decision and a
response-to-comment document. This process will formally apply to all
new pesticide active ingredients, first food uses, first outdoor uses,
and first residential uses and compliments the Agency's existing public
processes used to announce the availability of risk assessments and
decisions on older chemicals. This process can also be used for
potentially controversial decisions or topics; therefore, the Agency is
considering the use of this process to obtain comment on a risk
mitigation proposal to address our concerns with the spot-on pet
products. See the following press release for additional information on
the new process:
Public processes improve the dialogue surrounding controversial
pesticide registration decisions and give the public greater
opportunities to understand and participate in the decision-making
process.
Please let us know if you have any additional questions.
Best regards,
Kimberly Nesci
Kimberly Nesci, Product Manager 11
Insecticide Branch
Registration Division (7505P)
Office of Pesticide Programs
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(Below is email that Jan received from Kimberly Nesci at the EPA on 11/12/09)
Dear Ms. [deleted],
Thank you for your October 24, 2009, email to me and for your October 26, 2009,
email to Mr. Steve Owens. The Agency appreciates the level of public interest in
this topic, and we share your and the public’s concerns about the adverse events
these products may be causing.
First, I sincerely apologize for our delay in responding. Because you had been
copied on the correspondence with James TerBush in August, I didn’t realize I had
missed your message from September until I received your October 24, 2009, email.
Again, I apologize. I thought I would respond to your concerns in two parts: first by
explaining where we are in our review of the incidents in companion animals and
then by explaining how the Agency intends to collect and use public comments and
information in its decision-making process.
Status of the current evaluation
As you know, EPA is conducting an investigation of spot-on pet products like the
Sentry Pro XFC product that affected your dog, Choe. As part of that investigation,
the Agency requested additional information from the spot-on registrants about these
incidents. Because the registrants are legally required to report these incidents to us
under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Agency
is confident that the information received is accurate and reliable. See the following
Web page for links to the regulations.
The Agency is also conducting a thorough review of the additional information provided
by the registrants. We have established a team of veterinarians who work in the EPA’s
Office of Pesticide Programs and that team has reviewed the detailed information on
the incidents received and has prepared draft written reviews for those pet spot-on
products. These draft reviews are being peer reviewed by regulatory authorities from
the Food and Drug Administration’s Center for Veterinary Medicine and Canada’s
Pest Management Regulatory Agency (PMRA) in a 3-day meeting that took place
last week (from November 3rd through 5th). This was an internal meeting (that is,
government only) and the registrants were neither invited nor present. The Agency’s
formal analysis is expected to be completed shortly, consistent with our fall 2009
target date, at which time we will release information to the public on our Web page.
Please note that the Agency's formal review does not yet include final risk mitigation
conclusions. As noted in my previous email to Mr. TerBush, the Agency will implement
any regulatory decisions necessary to ensure that the pet spot-on products perform
their intended functions without posing unreasonable risks to humans, animals, or the
environment. These important public health decisions cannot be made until after the
formal, technical review has been completed. In addition, to ensure full transparency,
the Agency expects to obtain public input on any proposed risk mitigation before
making a final decision.
In addition, as you requested in your August 21, 2009, email, the Agency will be
pursuing revisions to the existing guidelines for companion animal safety studies.
This effort will follow the evaluation of individual products. However, the Agency
recognizes that this is very important in preventing adverse events in the future and
is committed to revising the test guidelines where needed to ensure that the pet
spot-on products do not pose unreasonable risks. See 870.7200 on the following
list for the details of how the companion animal safety studies are currently conducted:
Public participation in decision-making
As I mentioned in my August 27, 2009, email to Mr. James TerBush on which you
were copied, the Office of Pesticide Programs has a long history of commitment to
transparency and public participation in its regulatory decision-making processes.
We intend to honor that commitment in our evaluation of the pet spot-on products.
Since that letter was sent, the Agency has taken additional steps in making its
pesticide registration decisions more transparent. On October 1, 2009, the
Agency began a formal process by which risk assessments and proposed
regulatory decisions will be made available in the public docket for comment.
Following the 30-day public comment periods, EPA will publish its decision
and a response-to-comment document. This process will formally apply to all
new pesticide active ingredients, first food uses, first outdoor uses, and first
residential uses and compliments the Agency's existing public processes used
to announce the availability of risk assessments and decisions on older chemicals.
This process can also be used for potentially controversial decisions or topics;
therefore, the Agency is considering the use of this process to obtain comment
on a risk mitigation proposal to address our concerns with spot-on pet products.
See the following press release for additional information on the new process:
Public processes improve the dialogue surrounding controversial pesticide registration decisions and give the public greater opportunities to understand and participate in the decision-making process. Please continue to check our web page on pet spot-on products as well:
The Agency is making an independent evaluation of the safety of the pet spot-on products and will implement any regulatory decisions necessary to ensure that the pet spot-on products perform their intended functions without posing unreasonable risks to humans, animals, or the environment. We are very sorry to hear of Choe’s illnesses and the expenses that you incurred.
Best regards,
Kimberly Nesci
Kimberly Nesci, Product Manager 11
Insecticide Branch
Registration Division (7505P)
Office of Pesticide Programs
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(Below is email that Jan sent to Kimberly Nesci at the EPA on 11/12/09)
Dear Ms. Nesci:
Many thanks for your thorough reply. I most appreciate your outreach to public
advocates such as myself and Jim Terbush. I feel you recognize our angst in
attempting to contribute our experiences to reach out as you collaborate in your
decision making process. With due respect, may I point out a few observations
and comments.
First of all, Choe was not affected, as you mentioned by Sentry Pro XFC,
rather Frontline. I wish for you to remember that name because the product
manufacturer was totally negligent in providing the information on clinical
study trials as I requested several times and because they categorically
DENY that the spot-on product Frontline Plus could possibly result in an
adverse reaction when one contacts Merial Pharmaceutical customer service
number. Even after thousands of calls reporting adverse reactions their
customer service reps are `trained' to inform callers that they have `not before
heard of such an (adverse) reaction'. Most pet owners, unaware of such
blatant deceptive practices, hang up convinced, that their pet must be ill
from another source. Request several of your staff call and do spot checks
and see for yourself the spin they have created. Which brings me to your
comment, "Because the registrants are legally required to report these
incidents to us under the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA), the Agency is confident that the information received is
accurate and reliable." For the reason I mention above I regret that I
cannot agree with your evaluation that the information/statistics you
receive from the product manufacturers are accurate and reliable.
"On October 1, 2009, the Agency began a formal process by which risk
assessments and proposed regulatory decisions will be made available
in the public docket for comment. Following the 30-day public comment
periods, EPA will publish its decision and a response-to-comment
document."
Thank you for taking additional steps to include and potentially review
public comments. Along with this outreach, please construct a public
relations effort to spread the word about this public docket and actively
encourage the public to participate. The media should be notified via
press releases prior to the start of the 30 day period and your OPP
staffers should offer to provide interviews in print and video media.
30 days is not a long period of time. If the 30 days are provided
during the holiday season I'm concerned that the average person
will `miss' the opportunity to share with you their experience(s).
Your OPP staff should be proactive and collect data from websites
such as BioSpotVictims.org. The folks who have shared their
tragic stories over many years should, by prior reveal be counted
in this `transparency' vision supported by the OPP. Otherwise, truly
the numbers of concerned public advocates will be minimized.
If I can assist in any way, please do not hesitate to contact me.
Sincerely,
Jan [deleted]
for `Choe '-Frontline survivor
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Yesterday for the first time I applied Bio Spot for dogs 15lbs or under to my 9 month old Bichon Frise who weighs 12 lbs. I applied the Bio Spot around 9 AM and to my concern by 11AM, he was acting crazy, scratching, chasing his tail. At 1 PM, he was getting extremely agitated, still scratching, licking and now crying and yelping. At 3PM he was jumping, walking side ways with his butt curved toward his head and displaying all the other symptoms. At 5:30 he was dragging his body, and every 2-3 steps he would drop to the floor and roll around like a crazy dog.
I then decided to look up Bio Spot symptoms on the web and found your site. In horror and afraid I may have injured my dog while I was trying to protect him, I quickly gave him a bath in Dawn dish detergent. I am pleased to say after about 4-5 hours, I started to see my old dog again and by this 8 AM morning, Nov. 14, he appears to have no symptoms or adverse reactions. I have my jolly dog back! Thank you for creating this site, your readers for submitting their experiences and providing me helpful information that I could act upon quickly.
Michele w/ a Happy Dog 11/14/09
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(Below is email that I sent to Kimberly Nesci at the EPA on 11/15/09)
Dear Ms. Nesci,
Thank you for replying to emails from Jan [deleted] and me on November 12, 2009, and for taking the time to speak with Ms. [deleted]. I very much appreciate the EPA's commitment to transparency and public participation in its regulatory decision-making processes. Please allow me to submit the following comments.
In your email to Ms. [deleted] on November 12, 2009, you stated, "Because the registrants are legally required to report these incidents to us under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Agency is confident that the information received is accurate and reliable." I am disappointed to hear you say that because in the past, registrants such as Hartz have been fined or cited for failure to submit incident data, or for mischaracterizing the severity of reported incidents.
In October 2007, the EPA published a report titled, "OPP Report on Incident Information:
The Baseline," which indicated severe limitations in OPP's incident data collection system, including underreporting, lack of resources, and data lacking in sufficient detail. Here is the report:
Excerpts:
"While incident data may help provide perspective, it may not be of sufficient quality or quantity to be appropriate for use in risk assessment for every chemical."
"For the reasons listed above, it is very difficult to reach precise conclusions based on incident data."
In April 2009, the OPP presented an incident data update to the Pesticide Program Dialogue Committee (PPDC). In that presentation, OPP cited the need to develop an electronic web-based reporting portal for all incident data, specifically focusing on the reporting of registrant submitted 6(a)(2) data. It outlined the need for non-aggregate incident data and questioned whether registrants would voluntarily enter it into an electronic database prior to a new EPA ruling. Here is information on that presentation:
As I have mentioned previously, the EPA should not trust registrants to submit accurate and complete incident data. It certainly should not allow registrants to pay third-parties to manage their adverse incident claims because there is a financial incentive (and no penalty) for these third-parties to underreport adverse incidents to the registrants. It would be far better if pesticide labels advised consumers to report adverse incidents to the National Pesticide Information Center (NPIC), or a web-based reporting portal.
I regret that it has taken the EPA almost seven months to release its formal review of spot-on products, but I do appreciate the complexity of the task. However, I believe that it would be terribly unjust to release the formal review at this time. With the holiday season just around the corner, it seems unlikely that your formal review would receive the media attention it deserves. Therefore, the public would not utilize the 30-day public comment period. The only justification for releasing the formal review now would be to minimize damage to the reputation of registrants and stifle public participation.
I look forward to reading the formal review of your investigation, and hope to have the opportunity to comment on your proposed risk mitigation measures.
Thank you for your consideration.
Sincerely,
James TerBush
Website Administrator
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(Below is email that Farnam sent to a customer after her dog had to be hospitalized
for several days following an application of Bio Spot)
----- Original Message -----
From: Sherri Pike
To: [deleted]
Sent: [deleted]
Subject: Bio Spot Claim
Dear Ms. [deleted],
Farnam is in the process of reviewing your request for veterinarian bill reimbursement. We are sorry to learn that [deleted] required veterinary treatment.
At this time we do need to request some additional information so that we can complete our review. Please mail the following items to the address below to my attention and they will be reviewed upon receipt. Please be sure to include everything listed below as we cannot proceed without all of the below listed items.
1. Copy of the "medical records" related to this incident. (These are the notes taken by the veterinary staff at the time of treatment that explain the treatments given, [deleted] condition at the time and a diagnosis). The document you submitted is the discharge notes and not the medical records. Please request a copy of [deleted] medical records from the vet clinic if you do not have them.
2. Copy of all test results including the following: (You will need to request these results from the veterinary clinic as well).
a. CBC
b. Health profile - Prep panel
c. Activated Coagulation Time - blood test
d. Ultrasound written results
e. Radiology written results
3. Copies of any additional veterinary invoices, medical records and test results dated after [deleted] that are to be included for consideration for reimbursement.
Again, we are very sorry for what you and [deleted] have been through and do appreciate your help in expediting our review of your request.
Sincerely,
Sherri Pike
Farnam Companies, Inc.
Central Life Sciences
P.O. Box 34820
Phoenix, AZ 85067
(602) 285-1660
(602) 207-2183 Fax
"We make life better for animals and their people"
Even though her veterinarian indicated that Bio Spot could have caused her dog's illness, Farnam rejected her claim and refused to reimburse her vet expenses.
James TerBush
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Thanks for sharing these letters, Jan. You did an excellent job articulating your concerns regarding the efficacy and accuracy of the reporting process. I might add that the national Animal Poison Control Center, an organization within the ASPCA, also has a serious conflict of interest as it relates to cat and dog poisoning, injury and/or death. The APCC, led by Dr. Steven Hansen, senior vice president, has a consulting services organization in the APCC that, "...In addition to the assistance the APCC provides to pet owners and veterinarians through its Animal Poison Control hotline, the APCC provides extensive veterinary toxicology consulting on a wide array of subjects, including legal cases, formulation issues, product liability, regulatory reporting and biosurveillance."
In 2007 I reported the death of our pet to the APCC, among other organizations, and asked them to review our pet's medical charts and history. They did (for a fee, of course) and although the toxicologist that reviewed the medical history indicated that he could not conclusively offer a medical opinion that the product killed our dog. However, he also indicated that he could not rule out the possibility. Shortly afterwards, I received an email from his "team leader", a Dr. Mary Schell, who wrote that she had reviewed the toxicology report from her colleague. She indicated that the APCC report would not include the statement that the product "could not be ruled out as cause of death". Dr. Schell indicated that the primary ingredient, phenothrin, would not kill a healthy dog. I spoke with her on the phone and she disputed the findings and medical summary of our two attending veterinarians. Again, she reiterated that phenothrin would not kill a dog in good health.
Only later did I make the connection that her medical "judgment" resulted in no report of the incident to Hartz Mountain (see regulatory reporting above). That, of course, is very convenient for Hartz...the incident is never reported to them and therefore they cannot report it to the EPA. In the meantime, Dr. Hansen lends the considerable credibility of the ASPCA (whose total body of work I generally revere) by making many media statements supporting the products in terms of safety and efficacy and making a false choice by stating that the alternative to their use is a dangerous risk of flea or tick infestation and the diseases they cause, i.e., Lyme's, etc. Never is he quoted speaking about the safer alternative products and techniques that are available in the market today. I can only imagine the number of cases like mine that go unreported to the EPA or other regulatory agencies because the APCC makes the judgment that the product manufacturer's ingredients could not possibly be the cause of injury of death. Concurrently, they continue to enjoy their financial relationship with the product manufacturers through their "consulting services" organization.
One other little detail: Dr. Hansen was named "Veterinarian of the Year" on February 9, 2008 (for the year 2007) sponsored by--you guessed it--Hartz Mountain Corporation at the Purina Pro Plan Show Dogs of the Year Awards. Pretty disgraceful conduct by the ASPCA and APCC.
Thanks again, Jan. I was thrilled that she responded to your messages with a phone call. I'm sure you made some convincing and insightful points. I very much respect and appreciate everything you are doing.
Anonymous 11/15/09
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(Below is a letter that I sent to the EPA on 11/20/09 concerning a request by
Wellmark International to voluntarily cancel their carbaryl pet collar products)
The letter is posted in this federal docket:
Here is a comment that was posted by the NRDC:
James TerBush
Website Administrator
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CONSUMER ALERT
On October 26, 2009, EPA announced that it had received applications from
Schering-Plough Animal Health to register new uses for the pesticide, Indoxacarb.
The announcement was BURIED deep within this Federal Register notice (so much
for the EPA's new policy regarding openness and transparency):
Indoxacarb is currently registered for agricultural use and products that kill ants and cockroaches. Schering-Plough has proposed to use it for the first time in spot-on
flea and tick products for dogs and cats!
Here is some additional information on Indoxacarb:
Excerpts:
"CAUTION! Harmful if swallowed. Causes moderate eye irritation. Harmful if absorbed through skin. Avoid contact with skin, eyes, or clothing....Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals."
"Based on data from animal testing, Dupont Steward Insecticide may cause mild eye irritation with tearing, pain or blurred vision." (Dupont's Steward Insecticide contains 14.5% Indoxacarb).
"Based on data from animal testing, Dupont Steward Insecticide may cause irritation with itching, burning, redness, swelling or rash. Dupont Steward Insecticide may cause skin sensitization with allergic rashes."
"Based on data from animal testing, ingestion of large amounts of Dupont Steward Insecticide may cause alteration in blood cell counts and/or anemia."
"Dupont Steward Insecticide in high single oral doses caused gait abnormalities, incoordination, hypoactivity, convulsions, tremors, hypothermia, hair loss, labored respiration, discharge, and vocalization in rats."
"Ingestion of DPX-JW062 (containing 50% Indoxacarb, active ingredient) by dogs for one-year caused hemolytic anemia with secondary histopathological changes and decreased body weights. The NOEL for both male and female dogs was 40 ppm."
Excerpt:
"The dog seems to be the most sensitive species to the effects of Indoxacarb."
Excerpt:
"The substance causes damage to haemoglobin, resulting in an increased turn over of red blood cells. "
Excerpt:
"90-Day oral toxicity in nonrodents - dogs: LOAEL = 19 mg/kg/day based on hemolytic anemia, as indicated by decreased HGB, RBCs; increases in platelets, increased reticulocytes; and secondary histopathologic findings indicative of blood breakdown."
Excerpt:
"Short-term and long-term studies indicate that the targets of indoxacarb toxicity in rats and dogs are the red blood cells (RBC)."
Indoxacarb has a similar mode of action as pyrethroid-based insecticides: sodium channel blocker. It acts by binding to voltage-dependent sodium channels similar to the pesticide, Metaflumizone - the active ingredient in ProMeris.
In April, EPA issued an Advisory concerning spot-on pet products. It listed seven products that it said were responsible for 80% of the 44,000 reports of adverse incidents that it received in 2008. ProMeris for Dogs was one of the products on the EPA's Advisory.
Indoxacarb is designated by the EPA to be a "reduced risk" pesticide and is considered an organophosphate (OP) replacement. Reduced risk registration actions receive an expedited time frame for review. According to the following link, the EPA expects to complete its review of Schering-Plough's application by the 3rd quarter, 2010:
Here is a NOTICE OF FINAL DECISIONS TO DENY PESTICIDE PRODUCTS from the California Department of Pesticide Regulation, published June 22, 2009:
Excerpt:
Pursuant to Section 6255 (Title 3) of the California Code of Regulations, the Director of the Department of Pesticide Regulation files this Notice concerning pesticide products with the Secretary of the Resources Agency for posting. Unless specified, the reason for denial is that the required data was either not submitted or determined to be inadequate. This Notice must remain posted for a period of 30 days for public inspection. Contacts regarding this notice should be made to the Department of Pesticide Regulation's Pesticide Registration Branch at (916) 445 4400.
Tracking Number EPA Registration Number
Applicant / Brand Name
229729 - (NO NUMBER ASSIGNED)
SCHERING-PLOUGH ANIMAL HLTH CORP
SPAH 1.0
USE: INSECTICIDE - FOR THE CONTROL OF FLEAS ON CATS AND KITTENS
TYPE: SECTION 3 REGISTRATION -
ACTIVE INGREDIENT(S):
INDOXACARB
CAS NUMBER(S): 173584-44-6
Here is a report of indoxacarb poisoning in a human following a suicide attempt:
Excerpt:
"We describe the management of a case of methemoglobinemia secondary to ingestion of indoxacarb, an oxadiazine insecticide."
Methemoglobinemia is a blood disorder in which the body cannot recycle hemoglobin after it is damaged. Hemoglobin is the oxygen-carrying molecule found in red blood cells. In some cases of methemoglobinemia, the hemoglobin is unable to carry oxygen effectively to body tissues. (Source: Google Health)
Below is a letter that I sent to the EPA on 11/24/09:
James TerBush
Website Administrator
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Hello James,
I wanted to thank you again for maintaining your web site and your persistance in educating the public. I recently replied to the owner of this video on YouTube:
urging him to review the information available regarding the negative effects of
BioSpot. We still miss our dog and it is still a slap in the face, by Farnam, as we continue to read letters similiar to the one we received denying that their product
killed our dog.
Thank you again for what you do!
Diane 11/29/09
***************************************************************************************
James-
I only wish I had known to search for your website even 5 hours ago - BEFORE
I gave my cat a Bio Spot treatment. Three weeks ago my husband and I
adopted a dog from a local no-kill animal shelter, and they recommended the
Bio Spot for the dog. We also purchased a 3 month supply for the cat while
we were at it. We treated the dog last week with no problems, prior to
taking her for boarding, as we were traveling for the Thanksgiving holiday.
When we returned home today, we decided to go ahead and treat the cat,
also. The Bio Spot for cats indicated that it was for cats over 5 pounds,
and we were in the clear, as my cat weighs almost 20 pounds. We treated her
with the Bio Spot around 5pm and went on our way unpacking and cleaning up
the house. About 7pm my husband called to me saying something was wrong
with her, and I ran into the room to find her salivating profusely, her
tongue twitching from side to side and hanging out of her mouth, and her
panting heavily. I immediately scooped her up and we rushed her to the
emergency vet about 10 minutes away. We let them know we had treated her
with the Bio Spot and they immediately bathed her in Dawn. She also
continued to have respiratory distress, so they put her on oxygen. While I
was there she started passing bloody stool, and they started running further
diagnostic tests on her. Unfortunately she went into respiratory distress
before they could fully treat her, and she died in the process. The staff
at the emergency vet said they see problems with the Bio Spot on a regular
basis, especially with cats, and recommended that we stay away from using
this product in the future. I plan on notifying the animal shelter about
what happened with our animal so they can make sure to notify others of the
potential harm that Bio Spot can cause their animals. Further, I now know
that Bio Spot has the same toxicity of more well known flea treatments, but
a careful review of the packaging contains none of the strong warnings that
are contained on the other products. What a heartbreaking lesson to learn.
I have shared your website with all of my friends and acquaintances in the
hopes that this does not happen to any of their pets.
Sincerely,
Julie 11/29/09
Irmo, SC
Copyright © 2002-2009 BioSpotVictims.org All rights reserved.
DISCLAIMER: Below are messages that I have received from others whose dogs and cats experienced adverse reactions after using flea control products. I have no way of knowing if the information in these messages is factual, or if the products they used were the actual cause of the adverse reactions.
