Environmental Protection Agency (EPA) Completes Review of Seresto® Collar and Confirms Continued Registration; Data Affirms Safety Profile of the Product
July 13 2023 - 05:24PM
Business Wire
- Comprehensive, multi-year review by the EPA, with support from
the Food and Drug Administration, confirms Seresto continues to
meet EPA standards for product registration
- Data affirms the safety profile of the product
- Expert toxicologists and veterinarians voice their support of
Seresto’s safety profile
- Elanco and EPA forge stewardship program expected to raise the
bar for the flea and tick collar category
Elanco Animal Health Incorporated (NYSE: ELAN) and the U. S.
Environmental Protection Agency (EPA) today announced that EPA,
with support from the Food and Drug Administration (FDA), has
completed its comprehensive, multi-year review of the Seresto® flea
and tick collar. EPA confirms continued registration of the collar.
Comprehensive data affirms the safety profile of Seresto.
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As part of EPA’s scientific review process, the agency analyzed
incident data including third-party assessments and compared data
to other EPA-registered pet products. EPA’s conclusions found that
the most frequently reported incidents were primarily dermatologic
in nature, such as itching or redness around the collar site, which
is consistent with previous findings. According to EPA, Seresto
continues to meet all of EPA’s standards for registration under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which
ensures that products do not pose unreasonable risk of harm.
Following the comprehensive review, Elanco and EPA developed a
stewardship program that Elanco will implement as a leader in the
collar category. The program includes:
- Enhanced data collection for adverse event (AE) reports
- Continued annual enhanced reporting of Seresto AE data, similar
to what EPA requires for pet spot-on products
- Outreach to the veterinary community
- Review of the collar release mechanism
- Separation of product registrations for dog and cat
- Updates to package insert language
- Five-year registration review to ensure stewardship program
actions support the continued safe use of Seresto. Elanco will
complete a renewal process near the end of this period.
Elanco encourages EPA to implement these measures as a new EPA
standard across all flea and tick collars to ensure consistent
expectations for reporting across the category, similar to the
elevated standards the agency implemented in 2010 for pet spot-on
pesticide products (products applied directly to the skin of pets
for flea and tick control).
Since launch in 2013, more than 41 million Seresto collars have
been sold in the U.S. Over this period, the reporting rate for all
incidents related to Seresto has been low and trending downward. In
2022, the estimated incidence of adverse events in the U.S.
following exposure to Seresto was approximately 0.116%, which
equates to approximately 1 animal with a reported adverse event for
every 1,000 collars distributed in the U.S., the majority of which
relate to non-serious events such as itching or redness localized
at the collar application site.
The EPA’s conclusions align with those of authorities worldwide,
with Seresto being approved for use in more than 80 countries and
supported by veterinary professionals around the globe. The robust
scientific evidence – data generated prior to approval through
present day, including ongoing post-market surveillance data, and
broad use of more than 110 million collars around the world –
further supports Seresto’s safe use.
“We appreciate EPA’s diligence during this data-driven review
process, resulting in a clear outcome and continued product
availability to protect pets and human health,” said Dr. Ellen de
Brabander, Executive Vice President of Innovation and Regulatory
Affairs at Elanco. “We stand behind more than a decade of
science-based data, analysis and monitoring which affirms the
safety profile of Seresto. As a leader in animal health, we are
committed to the well-being of pets and welcome the opportunity to
work with EPA to implement these stewardship actions. We expect
these actions to raise the bar for flea and tick collars and
support the continued safe use of Seresto to protect pets from
fleas and ticks and the deadly diseases they carry.”
According to the Center for Disease Control and Prevention
(CDC), tickborne disease cases have increased 25% from 2011 to
2019.i The Companion Animal Parasite Council (CAPC) recommends
preventing contact between pets and parasites by using products
that kill and/or repel ticks.ii
Veterinary and Toxicology Experts Voice Their Support for
Seresto
Veterinary and toxicology experts around the country have been
vocal in their support of Seresto. With the EPA review complete,
experts share their thanks for giving pet owners the closure and
confidence they need during what has started as a heavier than
normal flea and tick season.
“Our Pet Poison Helpline data and experience supports the
overall safety profile of Seresto. The health protections these
collars provide by protecting pets from dangerous diseases that
fleas and ticks carry far outweigh the extremely rare risk of a
serious adverse event,” says Dr. Ahna Brutlag, Veterinary
Toxicology Expert from Pet Poison Helpline, a national animal
poison control center.
In-clinic veterinarians also continue to voice their support of
Seresto as a convenient, dependable and affordable option for
consumers.
“This conclusion from EPA comes at a critical time as pet owners
need to be thinking about protecting their pets from pests during
this heavy flea and tick season. As a veterinarian and pet owner
myself, I know the importance of protecting both pets and humans
from risks associated with fleas and ticks,” said Dr. Lisa Lippman,
practicing veterinarian. “With the Seresto collar, the substantial
body of scientific evidence continues to support its strong safety
profile and effectiveness to provide eight continuous months of
protection against fleas and ticks which can transmit dangerous
diseases, such as Lyme disease. Seresto offers a much-needed,
cost-effective option for protection. That’s why I fully support
and use Seresto and recommend it to pet owners for usage
year-round.”
Numerous studies and incident data analyses have concluded that
Seresto has a strong safety profile and does not pose an
unreasonable risk, which is why the American Veterinary Medical
Association has expressed support for Seresto’s continued EPA
registration.
ABOUT ELANCO
Elanco Animal Health (NYSE: ELAN) is a global leader in animal
health dedicated to innovating and delivering products and services
to prevent and treat disease in farm animals and pets, creating
value for farmers, pet owners, veterinarians, stakeholders, and
society as a whole. With nearly 70 years of animal health heritage,
we are committed to helping our customers improve the health of
animals in their care, while also making a meaningful impact on our
local and global communities. At Elanco, we’re driven by our vision
of Food and Companionship Enriching Life and our approach to
sustainability, Elanco Healthy Purpose™– all to advance the health
of animals, people, the planet and our enterprise. Learn more at
www.elanco.com.
i Trends in Reported Babesiosis Cases — United States, 2011–2019
| MMWR (cdc.gov)
ii Companion Animal Parasite Council | 2023 Annual Pet Parasite
Forecasts (capcvet.org)
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version on businesswire.com: https://www.businesswire.com/news/home/20230713309283/en/
Media: Season Solorio (765) 316-0233 season.solorio@elancoah.com
Investor: Kathryn Grissom (317) 273-9284
kathryn.grissom@elancoah.com
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