UPPER SAINT CLAIR, Pa. — Megan Lindeman adopted her cat, Ollie, 10 years ago just before Christmas. He has big, green eyes and an endearing snaggle-tooth.
“He is a quirky little guy,” Lindeman said. “He is a cuddle bug - he is just really sweet.”
Lindeman says last May, Ollie went to the vet for a routine dental cleaning. Without her knowledge or permission, Ollie was prescribed Zorbium, an opioid used to control pain in cats, post-operation. It goes right on a cat’s skin and helps control pain for several days.
Lindeman says Zorbium did not make Ollie feel better. She says Ollie started hallucinating and wouldn’t eat, drink or go to the bathroom.
“It was really scary,” Lindeman said. “I was really upset. I was really angry. I was concerned for him and his health and if he would recover.”
The vet said Ollie’s symptoms would go away in a couple of days, but they didn’t. This continued for a week and required Ollie to see a specialist and be prescribed medication to help him go to the bathroom.
Dr. Joshua Sharlin is an FDA Regulatory Expert Witness. He is trained in the regulation of drugs for animals and people. Dr. Sharlin has been on at least 50 cases, including testifying for drug death and injury cases.
He says there are some things pet owners should be aware of for any drug, including how long the drug has been out on the market.
“For myself, I tell myself, if a drug has been out for 3-5 years, then I will consider using it,” Dr. Sharlin said.
Dr. Sharlin says pet owners need to pay attention to the drug’s package insert. In Zorbium’s case, it’s intended for the control of post-surgical pain in cats.
“If it’s not post-surgical pain, you probably shouldn’t even be considering it,” Dr. Sharlin tells 11 Investigates.
The drug label lists side effects, but Lindeman says some of Ollie’s reactions were different, more severe and lasted even after the vet said the drug would have worn off.
Lindeman found the website, Zorbiumdeaths.com. On the website, pet owners share the injuries or deaths they say were caused by Zorbium, which is made by drug company Elanco.
The FDA posts adverse events from drugs to a publicly available website. We asked a data analyst to help us read the reports on Zorbium. She tells 11 Investigates there have been 266 reports of cat deaths related to Zorbium in two years.
“That’s a lot of cat deaths considering there were none in the clinic trials or in the follow-up,” Dr. Sharlin said.
If there is a death believed to be caused by the drug, the vet has to report it to the FDA.
“Every year Elanco is to produce an annual report where they talk about the cumulative picture of safety and adding information like what have we learned in the last 12 months,” Dr. Sharlin added.
Dr. Sharlin says the FDA reviews all annual reports for all drugs and will decide if they agree with Elanco’s findings, or if there needs to be a label change.
“That’s why you need numbers and a lot of time, years to go by,” Dr. Sharlin said. “That’s why the FDA requirements for a company to do safety reporting after approval is so important.”
As for Ollie, he’s recovered over time but still requires a higher dose of a different medication. Lindeman says she did report the adverse reaction to the FDA.
“I think it’s really important to talk to your vet and the staff about any medications they’re prescribing,” Lindeman said.
We reached out to Elanco, the drug company that makes Zorbium.
Elanco issued the following statement in response to our reporting:
“First and foremost, as pet lovers, we are always saddened to hear about any issues involving a pet. Pets are part of our families, and our goal as a leading animal health company is to help animals live longer, healthier, more active lives. We live this mission daily as we continually strive to bring pet owners and veterinarians new products that solve unmet needs. Prior to the approval of Zorbium in 2022, there were limited options for post-surgical pain management in cats.
Since Zorbium was approved, the product has filled an important need for veterinarians, helping provide safe, effective and reliable pain relief to their post-operative feline patients and removing pet owners’ burden of care to administer additional pain medication at home. Overall, the incidence reports of serious adverse events are rare, with fewer than 10 for every 10,000 units sold, from the approval date on January 20, 2022 through September 2024. It’s also important to remember that an adverse event report does not imply a causal relationship between a product and must be further investigated to determine cause. Additionally, events cannot be viewed in isolation due to potentially confounding factors. For example, all anesthesia and surgical procedures carry inherent risk, independent of Zorbium administration, especially in cats with pre-existing conditions; and anesthesia or surgical procedures can exacerbate underlying and unknown conditions. Elanco employs a team of veterinarians and veterinary professionals trained in pharmacovigilance to investigate all adverse event reports and continuously and rigorously analyze safety data to ensure the overall benefits of each approved drug outweigh potential risk. Elanco and the FDA continuously review data to ensure safe and effective products are being provided to veterinarians and pet owners.
All the available data we have today supports the safety and efficacy profile of Zorbium. We encourage pet owners and veterinarians alike to report all adverse events for any pet health products.”
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