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The US Food and Drug Administration warns pet owners and veterinarians that certain FDA-approved pet and flea medications containing the pesticide isoxazoline pose a potential risk of seizures in dogs and dogs. cats.
The FDA said in its September 20 alert that it was working with manufacturers of FDA-approved products and that it "continues to be safe and effective for the majority of animals" to include new information about event labels because these events were consistently observed in the class of isoxazoline-based products. "
"Since these products have been approved by the FDA, data received by the agency as part of its post-marketing activities indicate that some animals receiving Bravecto, NexGard or Simparica have experienced adverse effects such as tremors. muscles, ataxia and convulsions. " the FDA said.
"Another product in this class, Credelio, has recently been approved by the FDA, which is approved for the treatment and prevention of flea infestation and for the treatment and control of tick infestations."
NexGard (active ingredient afoxolaner) was approved in 2013 and claims to be for dogs and puppies eight weeks old or older, weighing 4 pounds or more; Bravecto (fluralaner), in 2014, available for dogs and cats; and Simparica (Sarolaner), in March 2016.
The manufacturer's website for Simparica says that it is "used only in dogs aged 6 months and older" and notes that "it can cause abnormal neurological signs".
The FDA statement added that the FDA "is working with manufacturers of isoxazoline-based products to include new information on labels in order to highlight neurological events, as these events have been observed consistently in the class of products based on isoxazoline. "
"The FDA has carefully reviewed studies and other data on Bravecto, Credelio, Nexgard and Simparica prior to their approval, and these products continue to be safe and effective for the majority of animals," the FDA said.
"The agency is asking manufacturers to make changes to product labeling to provide veterinarians and pet owners with the information they need to make treatment decisions. for each animal on an individual basis. "
He published a fact sheet on potential adverse effects for pet owners and veterinarians.
"Although most dogs and cats have not had neurological side effects," notes the card, "seizures can occur in animals without antecedents".
The FDA advises veterinarians "to use their specialized training to review the medical history of their patients and determine, in consultation with pet owners, whether a product of the isoxazoline class is suitable for l & # 39; animal ".
The FDA has stated that, although its scientists "carefully evaluate an animal drug prior to approval, new information could emerge after marketing, when the product is used in a much larger population."
"In the first three years after approval, the FDA pays close attention to reports of adverse events, looking for safety information that may emerge," the FDA said.
He stated that he "encourages pet owners and veterinarians to report adverse events" to the FDA or drug manufacturers.
The contact numbers listed for the manufacturers are as follows:
Merck Animal Health (Bravecto): 800-224-5318
Animal Health Elanco (Credelio): 888-545-5973
Merial (NexGard): 888-637-4251
Zoetis (Simparica): 888-963-8471
To report directly to the FDA, click on How to report side effects of animal medications and product issues.
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