Comment from Anonymous

I am writing as the owner of a cat who died following administration of Zorbium after a surgical procedure. I urge FDA to act on what happened to my cat and many other cats out there since 2022. Zorbium was administered to my cat without any prior disclosure to me. I was never told the drug's name, its route, dose, duration of effect, how to counter it if needed, or its potential danger to myself and other household members. I was not warned about the boxed warning or the risk of accidental human transdermal exposure. I was not told that the drug takes far longer than 30 minutes to dry, and that it remains wet and transferable to a person through contact with the application site, as shown in independent lab tests. Zorbium warns that it can kill a child, yet no parent is even warned about the drug's name or its dangers to cats or children. My cat's vets never offered me informed consent or suggested safer, longer-established pain-management alternatives. Instead, they opted for a new drug that cost the hospital about $10 per ampule and close to $100 to me. Their markup continues to be the primary guidance over safer buprenorphine alternatives. My cat was not a candidate for this drug. He was a senior cat with documented pre-existing conditions, all of them explicitly excluded from the group used to test the drug before its FDA approval. After the surgery, my cat started to recover well, so much so that the surgery team decided to cut his hospital stay short and rush him home, without informing me of the sudden plan change. They also rushed to apply Zorbium and lied about his symptoms starting shortly after he received the drug. They hid that he had to be seen by their ER team and placed in an oxygen chamber. At discharge, which I objected to, he was hypothermic to the touch, disoriented, not recognizing me, open-mouth breathing and gasping, with abnormal tongue movements and profound weakness. He was itching uncontrollably and he looked critically ill. I objected multiple times to taking him home and was told these were stress or expected side effects from Zorbium, and to bring him back only if it turned worse. And it did. Within hours I rushed him back as a life-threatening emergency. ER care focused first on asthma, then aspiration pneumonia, not on the recent Zorbium administration or the possibility of opioid-induced respiratory depression and a serious adverse drug reaction. The ER team had no clue what they were dealing with, which speaks to how poorly Elanco trains vets and staff about this drug. His course was textbook: progressive hypoxemia, rising PCO2, severe mixed respiratory and metabolic acidosis with a terminal pH below 7.0, rising lactate, electrolyte shifts including hyperkalemia, and cardiovascular collapse, the predictable cascade of untreated opioid-induced hypoventilation. He also showed signs consistent with a histamine-mediated allergic reaction to buprenorphine. Opioid reversal with naloxone was not attempted until roughly 24 hours after the drug was applied, far too late. He died in cardiac arrest. Necropsy did not support pneumonia. He died because Zorbium suppressed his breathing until his body could no longer get oxygen, and his heart, deprived of oxygen and pushed into a fatal rhythm, stopped. This was a death driven by the drug. FDA CVM is well aware of nearly 650 reported fatalities associated with Zorbium, as of end of 2025. FDA is also aware that in many of those reports, Zorbium was the only administered drug. FDA and Elanco are also well aware that many of those fatalities were young and healthy cats. Elanco is well aware that vets administer this drug off-label in nearly 50% of cases, and yet Elanco chooses not to properly train vets about its safe use. I respectfully request the following FDA action - withdraw Zorbium from the market. The combination of a fixed-dose, high-potency transdermal Schedule III opioid, a documented feline death signal, inadequate owner-level safeguards, and unenforced contraindications presents a serious risk that outweighs its benefit when safer, decades-established buprenorphine formulations exist. If FDA does not withdraw the product, require the manufacturer to add DEATHS as a known and reported adverse event in the labeling, including deaths in which Zorbium was the only drug administered. Owners and clinicians cannot weigh a risk that is omitted from the label!