ATLANTA - Federal safety regulators want new warnings on a popular flea and tick medication.
Channel 2 Consumer Investigator Jim Strickland first exposed complaints about Bravecto more than 18 months ago.
Strickland traveled to Pennsylvania to interview veterinarian Elizabeth Carney, who had asked the FDA to put a warning about seizures on the label.
"I'm not saying that I think the drug can't work for certain dogs but I think there's enough evidence that some dogs are falling ill after taking it that I think we need those answers," Carney told Strickland in 2017.
The FDA issued a safety communication that said the agency wants new labeling on four oral flea and tick drugs: Bravecto, Nexgard, Simparica and Credelio.
The agency said muscle tremors, ataxia and seizures were seen consistently among reported side effects.
The FDA stresses the products remain safe and effective for the majority of animals.
"These products are effective at killing fleas and ticks, but they come with a price," said Marietta veterinarian Dr. Michael Good.
Bravecto's maker, Merck, sent Channel 2 Action News the following statement:
"As part of its regular monitoring of all pharmaceutical products, the U.S. Food and Drug Administration (FDA) Conducted a review of the Isoxazoline class of Parasiticides. As part of this review, the fda has issued a drug safety communication and has requested updates to the prescribing information of all medicines in the Isoxazoline class – including Bravecto (Fluralaner) – to include information about possible neurologic adverse reactions in the precautions section.
Merck animal health remains confident in the safety and efficacy profile of Bravecto, which has been established through comprehensive clinical research in more than 170 studies. After three years of post-marketing surveillance of more than 80 million Bravecto doses distributed in 85 countries, the overall worldwide reporting rate for neurological signs, including seizures, remains classified as very rare, which is defined by international regulatory authorities as less than 1/10,000.
Nothing is more important to Merck animal health than the safety and efficacy of our products and the well-being of animals. We encourage all pet owners to speak to their veterinarian before making a decision about flea and tick control products. More than just a nuisance, fleas and ticks transmit disease and pose animal and human health risks. It is critical to protect pets from these parasites."
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