The safety monitoring of veterinary drugs like Zorbium is governed by strict regulations to ensure the well-being of our pets and their families. Here's what you need to know about the reporting process in the United States:
- Legal Mandate for Reporting: By federal law, specifically outlined in the Code of Federal Regulations (21 CFR Part 514), any adverse reactions to veterinary drugs must be reported to FDA (instructions here). This includes any negative effects or deaths experienced by cats, as well as injuries to humans from accidental exposure to Zorbium. For reference and reporting purpose, Zorbium's NADA # 141-547.
- Who Reports? If your cat has an adverse reaction to Zorbium, the veterinarian who administered the drug is legally required to report this incident. They should provide you, the cat owner, with a case or report number for your records.
- Timeline for Reporting: Veterinarians must report adverse reactions to the FDA as quickly as possible, typically within 15 days of the event for serious reactions. This prompt reporting ensures timely evaluation and response to any emerging safety concerns.
- Reporting to Elanco: In addition to reporting to the FDA, adverse reactions can also be reported directly to Elanco, the manufacturer of Zorbium by calling 1-888-545-5973 or +1-800-428-4441. Elanco is likewise mandated by federal regulations to report these incidents to the FDA, contributing to a comprehensive safety database.
- Public Availability of Data: Thanks to the Federal Food, Drug, and Cosmetic Act, all reported data on adverse drug reactions must be made publicly available on open.fda.gov. This transparency allows for broader awareness and understanding of the drug's safety profile.
- Accessing FDA Data: It's important to note that there is typically a 6-month lag in the FDA's reporting to the public, and the information is provided in a .json format. Accessing and interpreting this data may require some technical knowledge or assistance due to its complex format. Please contact us if you need help accessing their data.
By actively participating in the reporting process, you're not only ensuring the safety of your own cat but also contributing valuable data that can protect other cats and their owners. It's a collaborative effort that underscores the importance of vigilance and transparency in the use of potent veterinary medications.