The Decibel - The ‘miracle drug’ some dog owners regret using

Episode Date: December 11, 2024

Librela, a new drug to treat arthritis pain in dogs, was approved for use in Canada in 2021. In some cases, it was described to owners as a “miracle drug”, with no side effects other than potential soreness and swelling at the injection site. Some owners describe their dogs seeming happier and more comfortable. But others have reported adverse reactions, including lethargy, disorientation, vomiting, and even death. Zoetis, Librela’s parent company, says Librela is safe and was rigorously tested. Susan Krashinsky Robertson is a business reporter for the Globe. She spoke to eight people whose pets’ health declined after taking Librela. She’s on the show to talk about the promise of Librela, and what she heard from pet owners and veterinarians about the drug.Questions? Comments? Ideas? Email us at  [e-mail]

He was a labradoodle. We got him, he was eight weeks old. And we didn't have kids, so he was our kid. That's Ashley Burden, talking about Hudson, her 12-year-old labradoodle. He loved adventures on trails, and he came everywhere with us, camping, the cottage. He was down for everything. He lied, slept with us in bed, and loved his spoon, and he came everywhere with us, camping, the cottage. He was down for everything. He slept with us in bed and loved his spoon, and he was perfect. When he was showing signs of arthritis,

his vet prescribed a medication called Labrella. After the first two shots, he was like a puppy again. He could jump up into the Jeep, he was running around. But after Hudson's third dose, things started to change. Ashley explained this to Globe Business reporter Susan Krishinski-Robertson. You know, he was panting. He was urinating frequently. He just didn't seem himself. And a couple of weeks later is when the trouble really started.

Hudson became very lethargic and began vomiting. And she rushed him to an emergency vet, but they couldn't figure out what was wrong with him. But by the next day, he had just gone way downhill. He died, unfortunately. Ashley isn't alone. Other owners have also reported adverse reactions in their dogs after taking Labrella. Labrella's parent company, Zoetis, says the product has been rigorously tested and is safe. Today, Susan is here to talk about what she's heard from pet owners and vets and what Zoetis has to say about the drug. I'm Mainika Raman-Wilms, and this is The Decibel from The Globe and Mail.

Susan, thank you so much for being here. Thanks for having me. So what is Labrella supposed to do? So Labrella and a similar drug for use in cats, which is called Silencia, they're both made by a U.S. drug manufacturer called Zoetis. And they were the first two drugs of their kind to be authorized for veterinary use in Canada. So they were approved in 2021 and began being prescribed here just last year. They're designed to bind to a protein in the patient's body called a nerve growth factor. And that sends pain signals to the brain. So it's designed to basically disrupt those signals and relieve that pain.

So it's a pain reliever then? That's right. Yeah. And it's administered with a monthly injection. It costs about $100 a shot. And traditionally, a common prescription for pain has been non-steroidal anti-inflammatories, which are also known as NSAIDs. And those are a really typical prescription. But for older pets in particular who are affected most often by arthritis, they can be sensitive to the effects of NSAIDs on their kidney, their liver, and their gastrointestinal system. That's something that Health Canada actually noted in a report the same year that it approved Librella and Silencia for use here. And so these drugs are marketed as a new solution. And sales of animal drugs are growing,

partly due to advancements in medicines, as well as just the boom in pet ownership that we all saw during the COVID-19 pandemic. And Zoetis itself, they often talk about the human-animal bond that fuels their business. An investor presentation they made this year noted that particularly younger consumers, so Gen Z and millennials, are fueling what they called the humanization of pets. And they also cited research that's been done that found that 86% of pet owners would, quote, pay whatever it takes if their pet needed extensive veterinary care. Off the top, we heard this testimony from a pet owner, Ashley Burden. Did she have any concerns

at all going into the treatment when she was going to start putting him on labrala? Was there any concerns there? She had no concerns, and that was partly because the information she received at her clinic was that this was a very positive drug. And she was told that there were little to no side effects aside from maybe some swelling at the injection site. This is something I heard from many pet owners that I spoke to that initially the way the drug was presented was a very low risk option and that the information they were given was that there were no side effects. We should say Hudson's experience, it's never been conclusively proven that Librella was the cause of his health decline. But that is the way that most pet owners were presented with the drug. This is extremely safe, little to no side effects, maybe a little

swelling. Yeah. So it sounds like you did speak to a number of other dog owners then as well, Susan, who gave their pets labrella. What did they say about what that experience was like? So it really varies. For some people, it's important to say this has been effectively a miracle drug. You know, I spoke with one dog owner who said that she wasn't sure she'd still have her dog if it wasn't for this, that her dog was so clearly suffering that the time may have come for a really difficult decision had she not been able to see some effective solution for pain relief. And for her dog, that's exactly what has been. So she has a golden lab who has elbow dysplasia. And this dog was really clearly miserable, not playing, not really engaging, you know, very uncomfortable. And after the drug, which she's continued to give her dog, it's been a real turnaround. Still an elderly dog, still walking with a bit of a limp, but clearly not suffering in the same way. And so for some pet owners, this really has been an extremely positive treatment for their pets in order to extend their life and also extend their quality of life. And for others, they have reported noticing just a really alarming decline in their pet's health after their pets were given this drug. And again, it's hard to know what the

cause is definitively, because in a lot of cases, these are older dogs. But, you know, what I heard from one pet owner who spoke to me was, you know, yes, my dog is older. Her dog was nine at the time of the first injections. But what she told me is, you know, you don't go from a relatively healthy dog to a dog with eight or nine or 10 problems in a very, very short span of time. And for her, she really questions whether this drug was to blame for that decline, as do others. And what exactly were people noticing about their dogs? Like what kind of change in activities or changes were they seeing there? One story that stuck out in my mind was an owner who said her 10-year-old Rhodesian Ridgeback

had been really just a perfectly healthy dog before she had begun giving him the shots. He did have mild osteoarthritis, which is what this drug is for, but she said otherwise he was really doing very, very well, particularly for a 10-year-old. And she told me that she went from, in 24 hours, having a dog that could still jump into her SUV, maybe just with a bit of an assist because he had some stiffness, to a dog that couldn't control his back legs,

couldn't control his bowels. He was panting. He was drooling. He was stumbling around. There are also regulators who gather adverse reaction reports when it comes to drugs. That's true for human drugs, and it's also true for drugs for pets. And when we looked over the data from the European Medicines Agency, their database included a number of reports of adverse reactions. And when I read through those

reports, they included symptoms such as fever, lethargy, an inability to stand up. There was one story of a German shepherd who had been panting and who had had a seizure and subsequently died. So those are just some of the alleged reactions that have been reported to regulators. And Librella is made by a company called Zoetis. What has that company said about these claims of alleged side effects? So Zoetis says that Librella and Silencia for cats have been rigorously tested and that they are safe when they are used according to the label. The company also said that none of the reported clinical signs that we have talked about here

have been classified by the European Medicines Agency as quote-unquote more than rare. And what that means is that they've been reported in between one to 10 animals per 10,000 treated. Now, Zoetis did decline to provide the total number of adverse reaction reports that it has received related to Labrella, but what they told me is that they remain confident in the safety and effectiveness of the drug. Do we know about Canada specifically, Susan?

Like how often these alleged adverse reactions are actually tracked here in this country? So it's difficult to know how often they are reported because we don't have a comparison number of the total number of treatments administered. But Health Canada does track adverse reaction reports here under a division known as the Veterinary Drugs Directorate. Now, unlike adverse reaction reports for human drugs, the database of reports related to veterinary drugs is not made public. It's not really searchable anywhere online. That's something that many pet owners here are unlikely to know. So if they maybe go looking for this, they might

not actually find any information, at least not from Health Canada's own website. Now, we did ask the Veterinary Drug Database to provide us with numbers, but it can be difficult to contextualize those numbers for a couple of reasons. So one of the reasons is that each report can involve one or more health products. An animal may be taking one or more drugs at a time. And Health Canada also specifies that these reports should not be used as a basis for determining the incidence of a reaction or estimating the risk for a particular product. Since again, those total number of adverse reactions and the number of patients exposed to the drug are both unknown. But for

what it's worth, when we asked Health Canada for a summary of adverse reaction reports submitted for Labrella, they indicated that in the first half of this year, the agency had received 187 such reports, and there were 263 last year, the first year that it began to be prescribed. Do we know how widely it is being prescribed? Quite widely. This drug has grown fast, and that's something that the company has disclosed itself. So during a September appearance at a global health care conference, Soetis' CEO said that Labrella had seen the fastest growth in what she called clinic penetration, so it's penetration in veterinary clinics, of any product in the company's history. And it has reached in more than 80% of U.S. veterinary clinics, and what she said was very strong reorder rates. And then in its most recent quarter, sales of Labrella had reached $55 million U.S. And international sales of Labrella accounted for another $62 million U.S. And the company says that

more than 18 million doses of the drug have been distributed worldwide. And what Zoetis has said on the record is that they believe that this drug will be its next billion dollar franchise. We'll be right back after this message. Susan, I want to ask you about veterinarians here. What have they said because Labrella is an option for them. However, there are veterinarians who are raising concerns about what they are hearing from clients about their patients. I spoke with one vet in Australia who has raised concerns publicly about that. that Labrella would begin to be used more frequently for moderate cases of arthritis, in addition to where it started, which was really a drug for mainly focused on senior dogs with

severe osteoarthritis. The company has said that this fall, it's been out in the field doing some marketing work encouraging veterinarians to consider use of Labrella for more moderate cases. So we know that that is something that they are working on. And this one that I spoke to said, you know, it's possible that it's extremely rare that animals are not tolerating this drug and that there's a large number who are helped by it. But he believed that given what pet owners have been reporting, that there should be some discussion among veterinarians about whether it's smart to be using this drug as a first-line solution for treating arthritis.

He believes that this drug should be considered something of a last resort. And moreover, that it's something where veterinarians should be having much more detailed conversations about the possible risks with their patients and with their clients. He said that he personally would only prescribe it in cases where you're looking at maybe an animal who is reaching the end of its life and potentially could be given a little bit more comfort in its final months. But again, I think his main concern was that those conversations weren't happening at the veterinary clinic. In a lot of cases, the pet owners I spoke to told me, I just never heard that this was even a possibility. And they really would have liked to be able to make a more informed decision. Is there information that people can access on this drug

if they are considering it for their pet? So there are some changes that have been made in Canada since this drug came to market and even slightly before it came to market. So Health Canada conducts what it calls post-market surveillance once a drug is out there and being prescribed to determine, you know, whether there are safety issues that require action. And among the actions that Health Canada can take, those can include updating product labels, communicating new risks to veterinary professionals, or even pulling a drug from the market. Although what they told me is, you know, in order to pull a drug from the market, it would require a really strong safety signal with high reporting rates

and very serious consequences to the animal or person administering the product. And those would have to be instances where no mitigating risk factors could be identified. So the bar for pulling a drug off the market is quite high. But since Labrella was approved in Canada in 2021, there have been changes that have been made. As I mentioned, Health Canada has twice asked Zoetis to update the product label to reflect adverse reactions reported by the public. So the first happened actually before the drug began to be sold here based on updates in Europe, where it was already being used for a couple of years before it started being prescribed here in Canada. And then the second instance was in July of this year.

So Zoetis was asked to include an amended list of reported reactions, and Health Canada told me that that was, quote, due to an increase in frequency of their occurrence as compared to when previously reviewed. Okay. So Zoetis was also asked in July to provide what's called a new client information sheet. This is sort of more of an overview of the drug

that could theoretically be handed to a pet owner during an appointment to give them more information on a drug. And specifically, they asked them to list potential side effects. So those included decreased appetite, lethargy, balance problems, urinary incontinence, vomiting. And because Labrella is administered by veterinarians, Health Canada told me the new sheet was considered a good way to provide animal owners with more information, particularly because they might not have access to product packaging and the sort of inserts that

you usually find in a box of something if you're administering a drug to yourself. However, while vets can provide that new information sheet to clients, Health Canada can't require them to do so because they told me veterinary medicine is provincially regulated. Okay, so that's an important point then. So someone might not necessarily be getting that sheet of information when they're sitting in the vet's office. They certainly aren't required to. So I contacted some of the provincial veterinary regulators in some of Canada's largest provinces to ask whether they've communicated with veterinary regulators in some of Canada's largest provinces to ask whether they've communicated with veterinary professionals to either recommend or to require that this new information be provided

to owners before they administer Librella. And representatives for a couple of them did respond that vets are expected to share information about common side effects and serious risks before they administer a drug, but they did not confirm that any such communication had happened regarding Labrella specifically. And I heard from another regulator that essentially vets are under no obligation to provide this sheet to their clients, but they did say vets have a duty to inform clients of the nature of medications they prescribed, including any possible, quote, dangers, unquote, that the use of that drug might entail. So it sounds like in some situations, it might be difficult for people to actually access

some of this information. Are there, I guess, other ways that pet owners are finding out these things, Susan, or sharing information? Yeah, I think that some pet owners have felt that there hasn't been as much information out there as they would like. And as a result, we're seeing people turn to avenues that we don't actually typically associate with super reliable data, and that's social media. We've seen Facebook groups sprout up where owners have gathered together to share their experiences. And the difficulty there, of course, is, you know, just like with the data we talked about earlier, the reports of adverse reactions, it's hard to know when things were definitively caused by a drug. And also, of course, the people flocking to those groups are the most likely to have had negative experiences. But I did hear from pet owners that these groups

were extremely helpful for them, not only because they felt like they weren't alone in struggling with these, in some cases, really difficult decisions and really difficult times with their pets, but also because in a couple of cases, I heard from owners who were on the verge of putting their animals down when their health had declined in this way. And when they discovered information on social media, they saw some owners who had shared experiences of their pet's health improving once they had stopped the treatments. And it was a gradual process. And that convinced at least one owner I spoke to, to hold off putting her dog down to give the dog a chance to improve

and see if they could maybe have some more time with their pet. And in that situation, did the dog improve? Yes. And it did give her more time with him. He is still having some health difficulties, but it did stop her from euthanizing him immediately. And she did see some improvement in some of the behaviors she had noticed, such as disorientation and the loss of control in his limbs. And so it did give her some more time with her dog. Susan, I wonder, has there been any kind of action taken against Zoetis, the company that makes this drug? Yes, in the U.S. There's been a class action lawsuit that was filed by a pet owner in New Jersey just recently. And that lawsuit claims that Labrella has been associated with thousands

of reported adverse events in dogs. Those include some of the behavior we've talked about today, lethargy, incontinence, an inability to walk, and in some cases, death. The lawsuit also says that Zoetis' advertising and promotional materials have represented Labrella as safe without, quote, disclosing many significant adverse events associated with the product. So the lawsuit is alleging that the company has downplayed the safety issues associated with the drug. But it's important to note, of course, the allegations have not yet been tested in court. And Zoetis is aware of the lawsuit, but they added that the drug was approved through very robust and rigorous processes of global agencies, including Health Canada. So just lastly here, Susan, I mean, going forward, what have pet owners said that they would like when it comes to this drug? So many of the pet owners that I spoke to, the refrain I heard over and over was the concept of an informed decision. Many of them were really heartbroken that they felt that they hadn't done enough research on this drug before agreeing to

give it to their pets, but also questioned why this wasn't a more in-depth conversation with their vet at the time that the drug was prescribed. You know, I heard over and over from pet owners that, you know, their concern was really that other people should know raising as a possibility and having a conversation with pet owners so that pet owners can weigh the pros and cons for themselves before deciding to give this to their pets. A couple of folks that I spoke with said that even if they had been aware of these kinds of health declines as an infinitesimal possibility, that they wouldn't have risked giving this to their dogs, especially in cases where the dogs were quite healthy and the pain that they were experiencing didn't seem to be severe enough to warrant an intervention that carried any kind of alleged risk. Yeah, so this is like when it's been given in more moderate cases then. Yeah, and as I mentioned before, recommending this for more moderate cases

is something that the company is encouraging veterinarians to consider. And they have been advertising these drugs, which, as I mentioned, are a growing business for them. And in some cases, those ads have been placed in ways that have been very troubling to pet owners. So one of the pet owners I spoke with whose dog did not improve, she unfortunately faced the very difficult decision of putting her dog down. And she told me that, you know, it had been really sort of a horrific time in her words. And when she and her husband eventually decided to take their dog Rocco to be put down, they took him to the veterinary clinic. And before a dog is euthanized, the dog is weighed. And when he was being weighed,

they noticed that there was a rubber mat covering the scale, which had something printed on it. And when she looked closer, she noticed it was an advertisement for Labrella. Susan, thank you for your reporting and for being here today. Thank you. That's it for today. I'm Mainika Raman-Welms. Our producers are Madeline White, Michal Stein, and Allie Graham. David Crosby edits the show.

Adrienne Chung is our senior producer, and Matt Frainer is our managing editor. Thanks so much for listening, and I'll talk to you tomorrow.