Zorbium FAQ

For a concise and informative summary regarding Zorbium, its regulatory concerns, and the legal obligations for veterinarians:

• Zorbium Approval and Distribution: Approved by the FDA in January 2022 for post-op pain management in felines only, Zorbium was distributed to over 11,000 vet hospitals in the US by summer 2022. The first death report post-Zorbium was filed with the FDA on July 20th, 2022.
• Reporting Requirements: Veterinarians are legally mandated to report adverse reactions to the FDA, within 15 days of the event, including any negative effects or deaths caused by Zorbium.
• Public Data Availability: All reported data on adverse drug reactions must be made publicly available on open.fda.gov, ensuring transparency and awareness regarding Zorbium's safety profile. FDA publishes reported data with a 6-month delay.
• Veterinary Medication Consent Law in CA: Lizzie's Law requires California veterinarians to offer detailed information about prescribed or dispensed dangerous drugs to animal patients in an outpatient setting before administering the medication. This includes the drug's name, description, usage directions, storage instructions, and potential side effects. If requested, veterinarians must also provide drug documentation.
• Veterinary Medication Consent Law in NY: Buoy's Law mandates that New York veterinarians provide pet owners with specific details about prescribed, dispensed, or provided drugs to an animal before the medication is administered. This includes the drug's name, description, usage directions, storage instructions, possible side effects, and any manufacturer precautions. The aim is to ensure pet owners are fully informed about the medications their pets are receiving.
• Prescription Drug Use in Veterinary Medicine: The American Veterinary Medical Association (AVMA) stipulates that veterinary prescription drugs must only be used or prescribed within the context of a VCPR, and appropriate dispensing and treatment records must be maintained. Under the Animal Medicinal Drug Use Clarification Act (AMDUCA), extra label use of FDA-approved drugs in animals is regulated, allowing for such use under specific conditions set by the FDA.