Bravecto, Nexgard, Simparica and now Credelio are implicated in the FDA alert. Following drug approvals, the FDA monitors adverse events. In the case of the isoxaline class of flea and tick products, FDA’s post-marketing activities show some pets have experienced adverse events such as muscle tremors, ataxia and seizures. In the first three years after approval, the FDA pays particularly close attention to adverse event reports, looking for any safety information that may emerge.
The FDA is working with manufacturers of isoxazoline products to include new label information to highlight neurologic events because these events were seen consistently across the isoxazoline class of products.
Source: FDA, September 20, 2018. Link. A fact sheet has been provided for pet owners and veterinarians about potential adverse events associated with isoxazoline flea and tick products. <link>
The FDA continues to monitor adverse drug event reports for these products and encourages pet owners and veterinarians to report adverse drug events. You can do this by reporting to the drugs’ manufacturers, who are required to report this information to the FDA, or by submitting a report directly to the FDA.
Also see: Steve Dale, Todd McCracken, DVM: FDA flea and tick product warning, Pet Talk with Steve Dale, WGN Radio. Link. (includes podcast) Steve Dale speaks with Fear Free Certified Dr. Todd McKracken from Ceva Animal Health. Dr. McKracken discusses some concerns about certain flea and tick products due to a warning issued by the FDA, answers listeners’ questions, and more.
INSIGHTS: Kudos to Dr. McCracken and Steve Dale for balancing education, explanation and edu-marketing in support of helping pet owners and veterinarians understand individual pets’ reactions to isooxazoline flea and tick products are. There are excellent discussion clips that can be replicated from the radio program by sales representatives and veterinary teams.
Consider offering the podcast in social media posts, direct e-communications to clients using one of the products and with local media.