Antibiotic resistance gets discussed daily and globally. FDA recently convened a meeting to explore non-traditional therapies for bacterial infections (NNTBI). For the time being, no guidelines for the clinical development of NNTBIs are expected to be released. Beyond the challenge of defining NNTBIs, these diverse therapies challenge current models for biomarkers, safety, … [Read more...]
FDA alert – potential neurologic adverse events associated with isoxazoline class flea and tick products
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 … [Read more...]
FDA requires labeling changes for fluoroquinolones
This notice will interest animal health professionals, although it is about human use of the antibiotics. FDA is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects. Source: FDA, July 10, 2018. Link. FDA continues to monitor and evaluate the … [Read more...]