Message Board
April 2011
CLASS ACTION LAWSUIT
On 3/2/10, a lawsuit seeking class action status was filed on behalf of pet owners against Hartz, Sergeant's, and Summit VetPharm (maker of Vectra and Vectra 3D, which are sold by Banfield Pet Hospital's under the name FirstShield and FirstShield Trio).
On 8/25/10, a lawsuit seeking class action status was filed on behalf of pet owners against Central Garden and Pet - the parent company of Farnam (maker of Adams and Bio Spot flea and tick products) and Wellmark International (maker of Zodiac flea and tick products).
The lawsuits seek injunctive relief in the form of a recall of the offending products, a refund of the purchase price, for compensatory damages, punitive damages and other relief.
For additional information concerning this lawsuit, click here.
If your pet was harmed by a flea and tick product made by one of the above mentioned companies, and you would like to participate in this class action,
please contact:
Jacqueline Mottek
Positive Legal Group
415.302.5371 (cell)
***************************************************************************************
America's Children and the Environment - Third Edition
EPA is preparing a new edition of America’s Children and the Environment (ACE),
following the previous editions published in December 2000 and February 2003. ACE
is EPA’s compilation of children’s environmental health indicators and related information, drawing on the best national data sources available for characterizing important aspects
of the relationship between environmental contaminants and children’s health.
EPA is interested in your comments on the draft indicators for ACE3. EPA will consider
the comments and other information provided to EPA through this public review and a simultaneous peer review by technical experts in deciding whether to make revisions to
the indicators or other elements of the draft indicator documents.
The comment period runs from March 8 through April 21, 2011.
To share your comments, please send an email to ace3@epa.gov.
Please tell EPA to protect children from dangerous pet pesticide products!
***************************************************************************************
(Below is email that I sent to the EPA on 4/5/11)
To whom it may concern,
Thank you for the opportunity to comment on the EPA's draft indicators for America's
Children and the Environment, Third Edition (ACE3). BioSpotVictims.org, a non-profit organization which seeks to educate the public on the dangers of pet pesticide products, would like to express concern over the failure of ACE3 to consider pet pesticide products
as an indoor environmental contaminant that poses significant health risks to children.
According to the EPA, tens of thousands of pets are reportedly harmed each year by pet pesticide products, particularly spot-ons, which contain a high concentration of pesticide
and are applied to the backs of pets as a spot or stripe to prevent fleas and ticks. Adverse reactions from these products range in severity from skin irritation to chemical burns,
seizures, and even death of the pet.
Last year, after conducting a year-long investigation into pet spot-on incidents (which had been prompted by a sharp increase in reported incidents, and national media exposure),
the EPA announced the results of its investigation:
The EPA found that pet spot-on incidents were mainly due to labeled dosages that were
too large for small pets, and product labels that had inadequate instructions and warnings.
It also found that stricter regulations are needed to evaluate pet pesticide products before
and after they are registered.
Incredibly, the EPA reached many of the same conclusions when it evaluated the safety
of pet pesticide products in 1996:
Pet spot-on products have been on the market for well over a decade, but concerns over children's exposure to these products have largely gone unnoticed until recently.
In July 2009, Dr. Gail Krowech, a toxicologist at California's Office of Environmental Health Hazard Assessment, gave a presentation to California's Scientific Guidance Panel entitled Potential Designated Pesticides:
Here are some of Dr. Krowech's comments concerning fipronil, the main active ingredient in Frontline flea and tick products:
"Widely used tick and flea treatment for dogs and cats"
"Residues found in 40% of U.S. homes studied in 2005-2006"
"Potential hand-to-mouth exposure from contact with treated pets"
"Particular concern for children"
"Use is increasing"
"Potential concerns for cancer, hormone disruption, and developmental neurotoxicity"
According to a recent study of acute illnesses associated with exposure to fipronil, pet care products (Frontline) were related to more than one-third of cases and accounted for the majority of childhood cases (64%):
According to another study, which investigated fipronil residues on gloves worn while petting dogs after Frontline application, exposure to Frontline-treated pets pose human health risks:
In October 2009, Nicholas Halbach, a veterinarian and member of EPA's Pesticide Environmental Stewardship Program (PESP), submitted the following comments to the
FIFRA Scientific Advisory Panel, which had met to consider the EPA's draft guidelines
for its Standard Operating Procedures (SOP) for Residential Pesticide Exposure Assessment:
Here are some of Dr. Halbach's comments:
"The steady rise of reported toxicities to spot-on products with pets underscores the
potential health implications of chronic human exposure."
"Over 60% of U.S. households have one or more dogs and/or cats. Consequently, for many individuals spot-on treated pets may pose a single greatest source of chronic pesticide exposure."
"Spot-on products present a novel use of novel chemicals with undetermined endpoints in health effects. The range of active ingredients includes chemicals listed as both possible carcinogens and suspected endocrine disruptors."
In its review of the draft SOP guidelines, the FIFRA Scientific Advisory Panel expressed concern that EPA's risk assessment methodology did not adequately protect pregnant women, fetuses, and children. Furthermore, it was critical of EPA's definition of "toddlers"
as children aged 3-6.
The Panel stated, "using the toddler label for ages 3-6 is simply misleading and confusing.
In addition, exposure factor data collected from 3-6 year olds might lead to underestimation
of exposures to 2-3 year olds since hand-to-mouth and object-to-mouth behavior generally decline with age. Children with developmental delays, such as those with intellectual disabilities and/or autism, may still exhibit mouthing behavior at age 6. Finally, at least one Panelist is concerned that the Agency's questionable 'toddler' age selection is an indication that actual infant and toddler exposures have not been adequately examined."
Here are the minutes from the FIFRA Scientific Advisory Panel meeting:
Similar concerns had been expressed three years earlier by a group of EPA scientists and risk managers. They sent a letter to the EPA Administrator, stating that "EPA could betray
the public trust by violating the intention of the Food Quality Protection Act (FQPA) to protect the nation's infants, children, and susceptible subpopulations, unless the Agency adhered to principles of scientific integrity and sound science in the pesticide tolerance reassessment
it was undertaking."
Furthermore, they stated, "we urge the Agency to adhere to its principles of scientific integrity and employ the precautionary approach intended by the FQPA in assessing the cumulative and aggregate exposure and risk from the use of these neurotoxicants. This approach -- compliance with the FQPA and our principles of scientific integrity -- is the only way to remain faithful to the public trust and ensure that our children will not be exposed to pesticides that may permanently damage their brains and nervous systems."
Here is their letter:
Unfortunately, their advice went largely unheeded by the EPA, which abandoned the FQPA's 10X safety factor for many pesticides that are commonly found in pet pesticide products.
The Natural Resources Defense Council has also been highly critical of EPA's risk assessment methodology:
According to Miriam Rotkin-Ellman, public health scientist at the NRDC, EPA's risk assessments are based on the ridiculous assumption that young children only put their
hands in their mouth once a day while playing with a pet, and only with three fingers,
which grossly underestimates the danger of pet pesticide products.
Despite the fact that EPA's risk assessments are based on unrealistic assumptions,
they consistently show that pet spot-on products represent one of the most dangerous residential pesticide exposure scenarios for toddlers, with margins of exposure that
approach or exceed the EPA's level of concern.
The majority of pet pesticide products on the market contain pyrethrins and pyrethroids. Recently, the EPA expressed concern over a possible connection between allergic and respiratory reactions in susceptible individuals and the use of these pesticides. The EPA
is also concerned that young children may be at risk of developmental disorders from exposure to pyrethrins and pyrethroids. As a result, the EPA issued data call-in notices
for pyrethrins and pyrethroids in May 2009:
Recent studies have linked exposure to pyrethrins and pyrethroids with developmental disorders. Here is a study, sponsored by the National Institutes of Health and the EPA,
which concluded that it may be prudent to evaluate pyrethroid exposure as a risk factor
for attention-deficit hyperactivity disorder (ADHD):
Here is another study, conducted by researchers at Columbia University, which found that children exposed to higher levels of pyrethroids before birth scored 3.9 points lower on the Mental Developmental Index than those with lower exposures. The drop in IQ points was reported to be comparable to that observed in response to lead exposure:
For all the above reasons, BioSpotVictims.org urges ACE3 to consider pet pesticide products as an indoor environmental contaminant that poses significant health risks to children.
Sincerely,
James TerBush
Website Administrator
***************************************************************************************
(Below is a Freedom of Information Act request that I sent to the EPA on 4/8/11)
Please send me EPA's review of Sergeant's fipronil + cyphenothrin squeeze-on for dogs
(DP 371676), dated February 24, 2010.
Thank you for your consideration.
Sincerely,
James TerBush
Website Administrator
***************************************************************************************
(Below is email that I sent to Byron Backus at the EPA on 4/8/11)
Dear Mr. Backus,
I am writing in regards to your technical review of MRID 48129614, which was completed
on December 3, 2010:
On pages 3-4, it states:
"The review of February 24, 2010 included the comment [p. 15] that application sites had an oily wet appearance and that persistence of test substance on the hair of dogs for more than 14 days is of concern to potential human exposure. The registrant's response includes the statement: 'EPA has conducted risk assessments and determined that the intended exposure for each of the active ingredients in test substance II is acceptable in currently registered products.'"
Could you please let me know why TRB concluded that that response was adequate, especially given the fact that this new product has been assigned EPA Toxicity Category II
for eye exposure, and that Child Resistant Packaging is required due to its toxicity?
Thank you in advance for your reply.
Sincerely,
James TerBush
Website Administrator
***************************************************************************************
Yet again, 'safer' pesticides prove harmful
Excerpts:
Turns out a new generation of supposedly safer pesticides isn't so safe after all. In the latest entry of a growing body of evidence, scientists announced last week that pyrethroid pesticides — now in hundreds of pest control products sold for home use — can interfere with the healthy development of an infant's nervous system when moms are exposed during pregnancy. Here we go again.
History tells us that substituting one type of pesticide for another "safer" variety just doesn't work out very well.
In the grand scheme of things, the history of synthetic pesticide use isn't so very long. But sadly, that history is long enough that tens (maybe hundreds) of thousands of children have suffered the consequences — measured in life-changing health harms — of assuming the next generation of chemicals will be safe. And it's definitely long enough to learn this basic lesson: constantly shifting to the next best chemical fix not only doesn't work very well for controlling pests (that's a whole other story), it also isn't good for our health.
***************************************************************************************
(Below is email that I sent to Byron Backus at the EPA on 4/13/11)
Dear Mr. Backus,
I would appreciate a response to my email (above), which was sent to you on April 8, 2011, concerning your review of MRID 48129614.
As you are aware, post-application activities must be assessed on the same day that the pesticide is applied because it is assumed that individuals could handle/touch their pets immediately after application. In addition, EPA estimated risks are based on the assumption that an even loading of residues across the entire surface of the animal occurs immediately after application. The fact that currently registered products may contain the same active ingredients as Sergeant's proposed fipronil+cyphenothrin spot-on does not mean that Sergeant's formulation has the same chemical properties (including drying time) as currently registered products, therefore, it does not alleviate concerns over the potential for human exposure, and should not be used as justification for the registration of Sergeant's product.
I look forward to your reply.
Sincerely,
James TerBush
Website Administrator
(Below is a response that I received from the EPA on 5/2/11)
(Below is email that I sent to the EPA on 5/4/11)
Dear Ms. Gesalman,
Thank you for your letter of May 2, 2011, in response to my emails to Dr. Byron Backus regarding his review of MRID 48129614.
I appreciate the fact that companion animal safety studies include exaggerated application rates and are not used to determine potential human exposure. Nonetheless, the companion animal safety study referred to in MRID 48129614 raised concern about potential human exposure. It also must be pointed out that the current labeled application rate (4.0 mL) for Sergeant's etofenprox spot-on for dogs (EPA Reg. No. 2517-133) is TWICE the application rate that was originally proposed and used in the above companion animal safety study, and
it is considerably larger than the application rate of similar registered products.
Here is Dr. Backus' review of another etofenprox spot-on for dogs, made by Farnam:
Excerpt (p. 4):
"The most common observation (seen in all dogs of all 5 groups following the second treatment) was oily fur; this was gone by day 13
in Group A [1X dosage rate]."
Even a recent press release from Farnam alludes to the fact that its etofenprox spot-on for dogs takes a long time to dry:
Excerpt:
"Bio Spot Defense Spot On® Flea & Tick Control for Dogs mixes with the dog's normal skin and hair oils to spread naturally over the dog's entire body as he moves. Although the dog's skin and hair oils will distribute the product, brushing the dog 12 to 24 hours after application will help the product reach all over his skin."
In fact, the above statement was approved by the EPA and appears on Farnam's product label.
How long does it take Farnam's product to "spread naturally" if the dog is not brushed 12 to
24 hours after application? Why was that statement not required to be included on Sergeant's product label?
Sergeant's product label does allude to the fact that its etofenprox spot-on for dog takes a
long time to dry. It states:
"Households with more than one pet should not allow dogs or cats to groom each other until solution has dried. Separate the treated dog from all other dogs and cats for 24 hours after treatment has been applied. Cats or dogs that actively groom or engage in close physical contact with treated dogs may be at risk of serious harmful effects."
No mention of any risk from potential human exposure.
As you know, EPA human health risk assessments of pet spot-on products are based on the assumption that there is an even loading of pesticide residue across the entire surface of the pet, and risks are always assessed on Day 0 (the day of application) because it is assumed that people -- including children -- will have contact with their pet immediately following application:
Why does the EPA assume that an even loading of pesticide residue across the entire
surface of a pet occurs immediately following application of a spot-on product, especially when the facts indicate otherwise?
How can that assumption be viewed as conservative when it has the potential to greatly underestimate exposure to treated pets?
Sincerely,
James TerBush
Website Administrator
(Below is a response that I received from the EPA on 6/3/11)
(Below is email that I sent to the EPA on 6/8/11)
Dear Ms. Gesalman,
Thank you for your letter (attached) of June 3, 2011, in response to my questions concerning EPA's review of MRID 48129614. Please allow me to respond to the points you have raised.
Comment 1:
The EPA is dedicated to the protection of human health risks associated from exposures to pesticides, particularly those used in residential environments. The EPA assesses all pet pesticide treatments, including spot-on products, using a screening level approach with conservative assumptions and refines these as appropriate given data availability and
applicable changes in methodologies.
Response 1:
The Standard Operating Procedures (SOPs) for Residential Exposure Assessments assume that post-application exposures for toddlers are limited to one event per day, and are further limited to only 20 cm of one hand. These assumptions are not conservative or child-protective.
Furthermore, due to an apparent oversight, EPA failed to include permethrin spot-on products in its residential risk assessments until 2006, and failed to include phenothrin spot-on products in its residential risk assessment until 2008. When both these products were finally assessed using conservative assumptions, the assessments indicated risks of concern to toddlers.
Comment 2:
The EPA assumes that, upon treatment, the active ingredient is loaded across the entire surface area of a treated pet. This assumption was employed upon development of the Residential SOPs to account for the potential of adult and child contact with the entire surface area of the treated animal (for all pet product formulations assessed) because it is unlikely that contact is confined to a particular area.
Response 2:
The Residential SOPs were developed before the advent of spot-on products, and fail to consider their drying and spreading characteristics. After application, spot-on products leave an oily or wet appearance on the fur of pets which may persist for several days, and represent a significant risk of pesticide exposure.
Comment 3:
Based upon a recent review of all available residue transfer exposed studies, the 20 percent default assumption was determined to be highly conservative, approximately 20 times greater than that determined from the review.
Response 3:
All of the residue transfer exposure studies that were recently reviewed by the EPA were unpublished and submitted by companies that had a financial interest in the outcome. In regards to one of the studies (MRID 44531203), not only did the registrant have a financial interest, but one of the study's authors (Andre Weil) did, too. He just happened to be one
of the inventors of the fipronil pet treatment.
Comment 4:
On October 6-9, 2009, a revised version of the Residential SOPs was reviewed by the Federal Insecticide, Fungicide and Rodenticide Act Scientific Advisory Panel. Meeting minutes from the FIFRA SAP were received on December 16, 2009. The EPA is in the process of reviewing and incorporating these comments..."
Response 4:
The FIFRA Scientific Advisory Panel expressed concern that EPA's methodology did not adequately protect pregnant women, fetuses, and children. Furthermore, it was critical of EPA's definition of "toddlers" as children
aged 3-6.
The Panel stated, "using the toddler label for ages 3-6 is simply misleading and confusing. In addition, exposure factor data collected from 3-6 year olds might lead to underestimation of exposures to 2-3 year olds since hand-to-mouth and object-to-mouth behavior generally decline with age. Children with developmental delays, such as those with intellectual disabilities and/or autism, may still exhibit mouthing behavior at age 6. Finally, at least one Panelist is concerned that the Agency's questionable 'toddler' age selection is an indication that actual infant and toddler exposures have not been adequately examined."
Sincerely,
James TerBush
Website Administrator
(Below is email that I sent to the EPA on 6/10/11)
Dear Ms. Gesalman,
Thank you again for your letter (attached) of June 3, 2011, in response to my questions concerning EPA's review of MRID 48129614. I would like to provide additional comments to the points raised in your letter.
Comment:
The maximum application rate, expressed in terms of mg/kg of dog body weight, occurs when 2.0 ml of the subject product is applied to a 1.81 kg (4 lb) dog. The dose to a 1.81 kg dog is 629 mg of etofenprox/kg of dog body weight, which is less than the dose applied in the Companion Animal Safety study. Dr. Backus concluded that the 629 mg/kg rate was safe when applied to dogs. Any rate below that is also safe.
The 4 ml dose, when applied to 11-20 lbs dogs, results in a maximum dose of 456.31 mg etofenprox/kg of dog body weight (11 lb dog = 4.99 kg body weight).
Response:
In the February 24, 2010, review of Sergeant's Companion Animal Safety Study, Dr. Backus concluded that "the study is not acceptable to support the proposed use(s) on adult dogs and puppies and cannot be upgraded. Test groups consisted of 6 (3 male and 3 female) adult dogs or puppies. The 870.7200 Companion Animal Safety Guidelines specify at least 6 animals per sex should be used at each dosage level." Dr. Backus also noted that "since only one dog in this [adult] group weighed less than 9 lbs (4.06 kg = 8.95 lbs), the data could not be used to support the use of this formulation on adult dogs weighing 4-9 lbs, particularly as the ratio of body surface area to mass could be a factor in absorption and toxicity."
Based on the cumulative amount of test material applied to adult dogs, Dr. Backus concluded that the study supported a product dosage of 0.555 ml/kg, which is 316 mg etofenprox/kg of dog body weight.
Dr. Backus' review (dated February 24, 2010) also noted several significant deficiencies with Sergeant's study, including:
"It is also unclear why different combinations of products were tested in adult and juvenile animals."
"The study used three dogs/sex/group, whereas six dogs/sex/group are required."
"Individual animal data for clinical signs were not provided."
"Group mean values for body weight were not calculated for Days -14, -7, +1 and +7."
"The control formulation is described as "inert control substance". However, it is not certain for which of the test formulations was this the 'inert control substance,' as no analysis was provided."
"The date of birth of the animals was not provided."
"The mg/kg dose of active ingredients was not calculated."
"The laboratory which conducted the hematology and clinical chemistry testing is not GLP accredited."
"The Guideline allows for five hourly applications of a 1X dose to achieve the 5X dose. However, with the large volumes of test material used on some of the smaller animals, it is likely that the material ran off and was not available for absorption."
"The study report states that test substances IA, II and III were applied separately as terminally adjacent stripes, applying test substance IA anterior to test substance II or test substance IA anterior to test substance III. It is unclear how the second substance could be applied anteriorly when both were administered from the neck to the base of the tail."
"A certificate of analysis was not provided for each of the test substances."
In a second review, dated April 29, 2010, Dr. Backus, noted that "we would have preferred two separate studies (one with puppies, the other with adult dogs) and "at least six animals per sex should be used at each dosage level", nonetheless, he accepted Sergeant's argument regarding the numbers of dogs (combining Groups A2 and B3) treated at a 5X dosage rate with Substance II (55.16% w/w etofenprox, 8.78% w/w s-methoprene, 2.31% pyriproxyfen), and upgraded the study to acceptable. However, he did not address many of the other deficiencies that were noted in his previous review.
Additional Questions:
Given the fact that 0.555 ml/kg of product (316 mg etofenprox/kg of dog body weight) was determined to be a safe 1X dose for adult dogs in Group B3, and that the review stated that a large volume (significantly higher than the dose applied to adults) of test material applied to puppies in Groups A1 and A2 was likely to have run off and was not available for absorption, how did Dr. Backus determine that 629 mg of etofenprox/kg of dog body weight was safe?
Given the fact that the Guideline (OPPTS 870.7200 Companion Animal Safety) states, "Studies conducted to satisfy companion animal safety guidelines should be conducted in compliance with 40 CFR part 792 and 40 CFR 160 (Good Laboratory Practice Standards) and a statement of compliance should be contained within the final report," how was it possible to upgrade Sergeant's study (which was conducted in the Republic of South Africa by a laboratory that was not GLP accredited) to acceptable?
Given the circumstances under which Sergeant's study was conducted (i.e., to register new products that will help to mitigate the pet safety risk concerns associated with existing Sergeant's spot-on products), why was a study with so many significant deficiencies allowed to be upgraded to acceptable?
Sincerely,
James TerBush
Website Administrator
(Below is a response that I received from the EPA on 8/3/11)
Dear Mr. TerBush:
Thank you for your letter of June 10, 2011, containing further questions
about the U.S. Environmental Protection Agency’s review of MRID
481296-14. We are pleased to have an opportunity to address your
concerns.
After Dr. Backus concluded in his February 24, 2010, review of
Sergeant’s Companion Animal Safety Study that the study was not
acceptable to support the proposed use(s) on adult dogs and puppies and
could not be upgraded, Sergeant’s rebutted his findings, supplying
additional information. A second review then found the study upgradable
to acceptable, based on the additional information submitted.
Among the information received was a statement signed by the Study
Director and the Sponsor/Submitter that the study was performed in
accordance with applicable U.S. EPA regulatory requirements as set forth
in 40 CFR 160. Studies do not have to be conducted in a GLP-accredited
laboratory, but they do have to state that they comply with EPA
requirements, include a statement describing in detail all differences
in the practices used in the study and those required by 40 CFR 160 or
state that the person was not the study sponsor and does not know
whether the study was conducted in accordance with 40 CFR 160. Signed
and dated GLP, Quality Assurance and Data Confidentiality statements
were provided for ClinVet International. Pathcare Veterinary Laboratory,
which conducted the hematology and clinical chemistry analyses, is not
GLP accredited but is ISO 15189 certified.
You ask how Dr. Backus determined that 629 mg of etofenprox per kilogram
of dog body weight was safe. In the study, the test material was applied
at a 5X dosage rate, with 1X applied each hour for 5 hours to minimize
the runoff – as allowed in the Companion Animal Safety Guidelines (OPPTS
870.7200). Dr. Backus used the data from the puppies to determine the
safe dose for the adult dogs.
I hope this information answers your questions about MRID 481296-12
Sincerely,
Claire M. Gesalman, Chief
Communication Services Branch
Field and External Affairs Division
***************************************************************************************
FIDOPHARM AND THE ASPCA TEAM UP TO LAUNCH NEW PETARMOR™
OVER-THE-COUNTER FLEA AND TICK TREATMENT
Excerpts:
Actress and singer Mandy Moore joined FidoPharm today to introduce PetArmor™, the
first generic fipronil product available on retail shelves nationwide with the same active ingredients as Frontline®. To celebrate the launch, Moore, FidoPharm and the ASPCA® (American Society for the Prevention of Cruelty to Animals®) have teamed up for a national awareness campaign to highlight the importance of flea and tick treatments and other preventative pet healthcare.
Having selected PetArmor as an official flea and tick treatment, the ASPCA will use
PetArmor for dogs and cats at its adoption center and clinic. Pets adopted from the ASPCA through the end of the year – including animals recovered from ASPCA disaster relief and animal rescue efforts – will also be offered PetArmor.
“Because the ASPCA and FidoPharm share a common vision that all pets deserve the best care, it was an easy choice to make PetArmor an official flea and tick sponsor,” said Elysia Howard, vice president of marketing & licensing for the ASPCA. “With the support of PetArmor, we rest assured that needy dogs and cats will receive the effective flea and tick protection they need to live healthy, happy lives.”
In addition to providing free treatment, FidoPharm is donating up to $100,000 through the PetArmor Protection Pledge to support the ASPCA’s efforts.
Besides the prospect of receiving $100,000., why is the ASPCA promoting flea and
tick products? According to the EPA, pet spot-on products are reported to harm tens
of thousands of pets each year, and those are just the cases that are reported.
Several manufacturers of pet spot-on products pay the ASPCA's Animal Poison Control Center (APCC) to manage their adverse incident cases. The APCC also offers these manufacturers consulting on legal cases and product liability. That is a serious conflict
of interest!
PetArmor is made in India (that's right, the country that brought you Slumdog Millionaire
now brings you flea and tick protection that is more affordable and assessible to pet owners, including slumdogs) and was recently registered by the U.S. EPA.
Incredibly, instead of requiring toxicity and companion animal safety studies for PetArmor,
the EPA allowed the manufacturer to cite toxicity and safety data that had been submitted previously for Frontline!
To learn more about the risks of Frontline and its generic equivalent, go to:
***************************************************************************************
Study Links ProMeris to Pemphigus Foliaceus;
Pfizer Stopping Its Production
Excerpts:
A recent groundbreaking study of clinical, histological and immunological data of 22 cases
of Pemphigus foliaceus, or PF, shows evidence that it can occur as an adverse drug reaction to the canine flea and tick preventive ProMeris.
PF is the most common spontaneously occurring autoimmune skin disease of dogs and typically displays as lesions on the face, nasal planum and ears. The reaction is rare but serious, says the study’s lead author, Thierry Olivry, DrVet, PhD, Dipl. ACVD, of North Carolina State University.
Ultimately, ProMeris Duo (Metaflumizone–amitraz ), which is also used for treating demodicosis, will be discontinued. The product, marketed by Pfizer Animal Health, will
be available while supplies last or until mid-September. ProMeris Duo is called ProMeris
for Dogs in the US. It is a novel topical ectoparasiticide.
“ProMeris was one of the many products that Pfizer brought into its portfolio when we
acquired Wyeth/Fort Dodge Animal Health,” says Jim Brick, director and team leader
of U.S. marketing for Pfizer Inc.
“We have completed a thorough review and evaluation of the strategic fit into the Pfizer
Animal Health portfolio, and have made the decision to discontinue the manufacture and
sale of Promeris flea and tick control for dogs and cats.
Olivry’s goal in revealing his study findings is to provide veterinarians with information on
the prognosis and management of this disease. In addition to skin lesions, more severe reactions can occur and can be long-lasting.
“Specific information on the frequency of these severe adverse drug reactions isn’t available, but it is important that veterinarians are aware of the product’s potential to cause the patient harm,” Olivry says. “Caution needs to be exercised if a vet decides to use this drug.”
Products that harm pets don't strategically fit into any business portfolio.
When ProMeris was first introduced, it was touted as "the next generation of flea control for dogs and cats."
The ProMeris website stated:
"For years we've used insecticides to control fleas on pets and in the environment. Many of these chemicals have been around for decades. Perhaps we’ve relied upon these older chemistries for too long and are in need of something new."
However, prior to the approval (registration) of ProMeris, the EPA had serious concerns
about its safety:
Despite concerns that ProMeris would "result in a significant number of adverse incidents involving treated dogs," the EPA registered it anyway!
Hopefully, this will be a "teachable moment" for the EPA, the veterinary community, and
pet owners.
Don't be in a rush to embrace new products. New doesn't mean safe.
P.S. Thank you, Lisa, for bringing this to my attention!
***************************************************************************************
INTRODUCING NEW BIO SPOT DEFENSE SPOT ON®
FLEA & TICK CONTROL FOR DOGS
Excerpts:
Bio Spot Defense Spot On® Flea & Tick Control for Dogs mixes with the dog’s normal skin and hair oils to spread naturally over the dog’s entire body as he moves. Although the dog’s skin and hair oils will distribute the product, brushing the dog 12 to 24 hours after application will help the product reach all over his skin. This product is water resistant and remains efficacious following exposure to rainfall or swimming; it also contains lanolin for coat conditioning.
“Bio Spot Defense Spot On® Flea & Tick Control for Dogs contains etofenprox, the same active ingredient found in Bio Spot® Spot On® Flea & Tick Control for Cats, to help reduce concern for cross-species contact in mixed cat/dog households,” added LeVeau. “It is important that consumers never use flea and tick control products for dogs on cats. They should only use products labeled for cats on cats.”
Contrary to Farnam's press release, Bio Spot Defense poses a serious risk to cats. What's worse, there are no warnings about it on the label!
Farnam initially wanted to include on the product label, "Based on testing, accidental
exposure to cats will not cause serious harmful effects," and "Can be used in households
with dogs and cats," but the EPA rejected those claims:
The main active ingredient in this new product is etofenprox -- a pyrethroid-like pesticide.
It is also sold under the name Adams™ Flea & Tick Spot On® E30 for Dogs.
Etofenprox is found in several brands (including Adams, Bio Spot, Hartz, Sergeants, and Zodiac) of spot-on products for cats, but it has the potential to harm cats -- especially if cats are accidentally treated with dosages meant for dogs, or if it's ingested while grooming themselves or another treated animal.
Signs of pyrethroid poisoning in cats may include: drooling, ear flicking, loss of coordination, lethargy, muscle temors, seizures, hyperthermia, and death.
Here is PetSmart's website regarding Bio Spot Defense:
Excerpt:
"DO NOT USE ON CATS! May be toxic and potentially fatal if applied to or ingested
by cats. Cats that actively groom or engage in close physical contact with recently treated dogs may be at risk of serious harmful effects."
Bio Spot Defense may also pose a risk of pesticide exposure to humans -- especially
small children.
According to the EPA's companion animal safety study for Bio Spot Defense, the most common observation after the second treatment was oily fur, which persisted for almost
TWO WEEKS:
Households with small children or cats should avoid using this product.
***************************************************************************************
I came across your site while to trying to research the dangers of Comfortis. I have a
one year old Boxer, a six year old Rat Terrier and a 6 year old Miniature Rat Terrier, all
three of my dogs were healthy. Unfortunately I went to Petsmart's Banfield Clinic and
was able to purchase 3 tablets (depending on weight) to give to all three of my dogs for
flea control. I was able to obtain this product without ever seeing or speaking to a
veterinary Dr. This was the first time that I had used this product and gave all three of
my dogs a Comfortis tablet Sunday night (4-17-11) and within hours all three of my dogs began to vomiting severely. Fortunately the vomiting lasted only a few days but my
miniature Rat Terrier began to become very disoriented, began to tremble, his eyes
became hazing and glazed and his pupils were dilated and had become blind 4-20-11.
Just early that day he had been chasing my Boxer around the yard and doing well. I
called the 1800 number for Comfortis/Elanco and spoke to one of their Veterinarians
by the name of Dr. Rosencran and at her request I took him to my vet to be examined
at their expense. My Vet completed a full check up and eye stain on my dog and could
not see anything that would have caused my dog to go blind within hours. My Vet recommended my dog be referred to see a special veterinary ophthalmologists. Elanco immediately called my vet and approved the ophthalmologist visit for my dog next week.
The more I research the side effects of Comfortis, the more I am reading about dogs
going blind in the same manner that my dog did. It sounds to me that Elanco is well
aware of what's going on and knows more than they are saying!
Yvette 4/24/11
***************************************************************************************
(Below is email that I sent to Kimberly Nesci at the EPA on 4/28/11)
Dear Kimberly,
Next week is National Pet Week, an annual event which focuses on responsible pet ownership, recognition of the human-animal bond, and public awareness of veterinary medicine. It seems like it would be an appropriate time for the EPA to release its much anticipated and long overdue response to the public comments that were submitted in
regards to the pet spot-on investigation.
Since it has been almost a year since the comment period ended, I anticipate a
detailed and carefully considered response to those public comments.
Sincerely,
James TerBush
Website Administrator
Copyright © 2002-2011 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.
Search
