More than 30 years of adverse event reports related to animal drugs and devices used in animals is now available online as part of the FDA’s commitment to increase transparency. Previously, this detailed level of data was only available via a Freedom of Information Act request. It is now electronically accessible and available for automated searching. < link > The FDA … [Read more...]
FDA investigating potential link between certain diets and canine dilated cardiomyopathy
Updating a collaboration that began in July 2018, the FDA believes that the potential association between diet and DCM in dogs is a complex scientific issue that may involve multiple factors. The FDA’s Center for Veterinary Medicine (CVM) and the Veterinary Laboratory Investigation and Response Network (Vet-LIRN) will continue to investigate this potential association of … [Read more...]
FDA approves Pexion for canine noise aversion
Prescription help for dogs with noise aversion challenges is on the way. The FDA has announced approval of Pexion® (active ingredient: imepitoin) by Boehringer-Ingelheim to treat noise aversion in dogs. The drug was approved in 2013 in the EU for reducing the frequency of seizures associated with idiopathic epilepsy. Imepitoin is similar to Valium (diazepram) and other … [Read more...]
Conclusions from FDA’s meeting on non-traditional therapies for bacterial infections
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...]