FDA Expands Labels for Credelio Quattro and Credelio to Include Lyme Disease Prevention and Protection Against Longhorned Ticks

he U.S. Food and Drug Administration (FDA) has approved updated labels for two canine parasiticides, Credelio Quattro™ (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets) and Credelio™ (lotilaner). The updated labels now include:

  • Prevention of Lyme disease through the elimination of black-legged ticks (Ixodes scapularis).

  • Treatment and control of longhorned tick (Haemaphysalis longicornis) infestations.

This label expansion is in response to emerging data on tick distribution and tick-borne disease prevalence. The Companion Animal Parasite Council (CAPC) reports more than 422,000 cases of Lyme disease in dogs so far this year, exceeding the total annual cases in 2019. Both dogs and humans may encounter ticks in common environments such as backyards or walking areas, emphasizing the importance of year-round tick protection for dogs.

Lotilaner and Tick Efficacy
Lotilaner, the active ingredient in both products, has demonstrated efficacy against multiple tick species. The updated label includes a claim for the prevention of Lyme disease in dogs as a result of killing black-legged ticks, which are the primary vector for this pathogen.

Longhorned Tick Considerations
The longhorned tick is an invasive species now reported in 22 states, capable of reproducing without mates and potentially forming large populations. These ticks can transmit pathogens including Ehrlichia and Babesia to dogs. Published studies in Parasites & Vectors indicate that both Credelio Quattro and Credelio achieve 100% efficacy against longhorned ticks within 48 hours of infestation, maintained for up to a month.

Other Tick Species
Both products were previously approved for the lone star tick (Amblyomma americanum), American dog tick (Dermacentor variabilis), and brown dog tick (Rhipicephalus sanguineus). These ticks can transmit pathogens to dogs and, in the case of lone star ticks, are associated with alpha-gal syndrome in humans. Lotilaner has been shown to have rapid and sustained efficacy against these species.

Clinical Implications
Veterinarians can now consider Credelio Quattro and Credelio as options for year-round tick and flea control, including protection against Lyme disease and emerging tick species. The label updates provide additional information for clinical decision-making regarding parasite management in dogs.

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