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Chairman of U.S. House of Representatives subcommittee asks for action based on misleading media reports
Elanco stands behind the safety profile associated with Seresto®, remains available to consumers
Based on recent misleading media coverage, a U.S. House of Representatives subcommittee chair made a request to Elanco Animal Health, Incorporated (NYSE: ELAN) to temporarily remove Seresto collars from the market. Elanco reiterates that it stands behind the safety data of Seresto generated for its registration and monitored via post-marketing surveillance.
All data and scientific evaluation used during the product registration process and through Elanco’s robust pharmacovigilance review supports the product’s safety profile and efficacy. Therefore, no market action, such as a recall, is warranted, nor has it been suggested by any regulatory agency. Elanco continues to stand behind the safety profile for Seresto. The product remains available to consumers across the U.S. and around the world for protection of pets from fleas and ticks, which can negatively impact their quality of life and may act as vectors of dangerous disease.
Since its initial U.S. Environmental Protection Agency (EPA) registration in 2012, more than 25 million Seresto collars have protected dogs and cats in the U.S. from fleas and ticks. In that time period, the incident report rate for all adverse events related to Seresto in the U.S. has been below 0.3%. Furthermore, the significant majority of these incidents relate to non-serious effects, such as dermatologic application site issues.
As a globally distributed product, Seresto’s safety data was rigorously reviewed over the course of its development prior to registration by more than 80 regulatory authorities around the world, including the U.S. EPA. Importantly, as regulated by the EPA, Seresto remains available on the market.
Elanco is cooperating with the Subcommittee’s request and looks forward to explaining how the media reports on this topic have been widely refuted by toxicologists and veterinarians. Elanco believes that any further reporting on these matters should be based on the relevant science and facts.
"There is no medical or scientific basis to initiate a recall of Seresto collars and we are disappointed this is causing confusion and unfounded fear for pet owners trying to protect their pets from fleas and ticks," said Dr. Tony Rumschlag, senior director for Technical Consultants at Elanco. "The recent media reports were based on raw data and cannot be used to draw conclusions on what may have actually caused the issues. It is critically important to understand that a report is not an indication of cause...if a dog were to be wearing a collar and experienced any sort of health issue, the collar would be mentioned in the resulting report as required, even if the collar was very obviously not the source of the issue. In most cases, further investigation and assessment are required to determine cause, often a veterinary exam, laboratory diagnostics, or necropsy, as appropriate. Data are continuously monitored for signals or trends. Thorough investigation of available data has shown no established link between exposure to the active ingredients in Seresto and pet deaths. Taking drastic action such as a recall results in unjustified worry and confusion that may increase pet exposure to disease carrying parasites like fleas and ticks."
Elanco takes the safety of its products seriously and has policies to ensure that concerns related to their use are investigated and addressed as appropriate. As with all its products, Elanco will continue to take actions to achieve the highest levels of safety and efficacy.
Elanco Animal Health Incorporated (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 are driven by our vision of Food and Companionship Enriching Life and our Elanco Healthy Purpose™ ESG/Sustainability framework – all to advance the health of animals, people and the planet. Learn more at www.elanco.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210319005181/en/