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FDA Alert Regarding Flea & Tick Medication

What You Should Know

  • The information that will be added to all isoxazoline labels identifies the potential for neurologic adverse reactions.
    • The labeling for Simparica® (sarolaner) Chewables has always included information about the potential for neurologic signs such as tremors, unsteadiness, and/or seizures that have been associated with use of it in some dogs.
    • Merial updated the NexGard®(afoxolaner) Chewables label to include the new precaution when they added the Lyme Disease prevention claim to the label.
    • The labeling for BRAVECTO® (fluralaner) – Topical Solution for Cats‎ and Dogs already includes the precaution about the potential for neurologic signs.
    • Merck will have to update the BRAVECTO® (fluralaner) Flavored Chews for Dogs prescribing information to include information about possible neurologic adverse reactions in the precautions section.
    • Elanco will have to update the Credelio®(lotilaner) Chewable Tablets prescribing information to include information about possible neurologic adverse reactions in the precautions section.
  • As is noted in the public advisory, the FDA-CVM carefully reviewed studies and other data on all isoxazolines prior to approval, and these products continue to be safe and effective for the majority of animals.
  • The most commonly reported adverse events globally are:
    • Vomiting
    • Diarrhea
    • Lethargy

FDA-CVM has also provided a fact sheet for pet owners. You can click here for a copy.

We have been prescribing these products since Nexgard was released five years ago and have not had any patients with neurologic symptoms. In fact, we have switched patients with seizures from Trifexis to NexGard because of the adverse reactions associated with Trifexis.

Here is a video with more information: