Librera side effects

Piper's mom

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As the new arthritis drug Librera becomes more popular I’m hearing more and more possible dangerous side effects. I would definitely encourage anyone who is considering this drug to do your own research before giving this to your dog.
I came across this article in my news feed today (posted by Rodney Habib) and I had to share it for all to read. I do believe the drug companies play with our heart strings when they advertise these new treatments and they downplay or outright don’t inform us (or the veterinarian’s) of the risks. I found these testimonials shocking to say the least.

https://www.cochraneeagle.ca/beyond...racle-drug-librela-for-arthritic-dogs-9813751
 
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I have one friend who did the research and was very hesitant about using it but eventually did for her almost 15 year old Sheltie who was in such discomfort with arthritis. It did help her and she thankfully did not have any side effects. But reading that article is very concerning. My vet had mentioned to me it has been used in Europe for quite a while already and she didn't seem too concerned about potential side effects. I'm always leery of new medications though for both people and pets.
 
Thanks for posting this, Lisa. I wouldn't touch this one either. This is the same company that makes the flu vaccine that made Ruffles sick and almost killed Sprite. And when my vet called them they didn't ask a single question, just immediately paid the vet. I wouldn't trust anything they make.
 
I have one friend who did the research and was very hesitant about using it but eventually did for her almost 15 year old Sheltie who was in such discomfort with arthritis. It did help her and she thankfully did not have any side effects. But reading that article is very concerning. My vet had mentioned to me it has been used in Europe for quite a while already and she didn't seem too concerned about potential side effects. I'm always leery of new medications though for both people and pets.
I was very concerned too Sharon especially seeing as how Piper has arthritis in his elbow! He actually had a flare up Tuesday evening…I went to bingo and he was fine, came home and he could hardly walk! Fortunately Metacam works for him and I only had to do 2 days and he was fine.
I know I’d asked my vet about that drug months ago and she said to exhaust other treatments first, probably with good reasons.
It’s hard to see your dog in pain! Tuesday evening I had to carry Piper outside and then upstairs to the bedroom (and I have 13 stairs to the top)! Fortunately by morning he was able to do stairs down very slowly (I’m sure he would’ve run down if I let him!).
 
Thanks for posting this, Lisa. I wouldn't touch this one either. This is the same company that makes the flu vaccine that made Ruffles sick and almost killed Sprite. And when my vet called them they didn't ask a single question, just immediately paid the vet. I wouldn't trust anything they make.
I don’t blame you Ann! After reading that article it makes me question a lot. Plus makes you wonder what else can happen when this drug messes with the brain…
 
Adverse events for human drugs are classed by frequency and listed in the drug inserts. common adverse events are defined as those occurring in more than 1/100 subjects (1%), infrequent adverse events are those occurring in 1/100 to 1/1,000 (0.1-1%) patients and rare events are those occurring in 1/1,000-1/10,000 patients (0.1-0.01%), very rare is less than 1/10,000 (0.1-0.01%). Animal drugs have much much more lax rules for approval but for biologics there are usually cognate human drugs you can look up for better idea on side effects.

librela is an anti-NGF (nerve growth factor) monoclonal antibody. there are 2 human 'versions' fasinumab and tanezumab in clinical trials. from what I can see at a glance, there are no significant signs of unusual side effects (outside of RA progression) like mentioned in this article, but if you are in the rare to very rare window you would need more than 1,000 patients to see them at all and more than 10,000 to see enough to know it isn't noise. One of the challenges with pet medications is things like this are NOT tracked and you end up in anecdotal report land. Also, no way to rule out a negative drug interaction since a lot of these pets are on multiple meds.

FYI.. very very few drug companies manufacture their own drugs. they outsource to companies that all they do is manufacture drugs (and these are often scheduled out a year in advance). A flu vaccine would often be made by a company that specializes in vaccines, a monoclonal antibody by a company that specializes in monoclonal antibodies. In the vet med world, companies also don't usually do their own research but co-opt an existing human drug from whatever company(ies) they find desirable and they can find data on.
 
Thanks for breaking that down for us Cindy and for the explanation, it helps to understand the whole process.

i came across the drug application for Librera (freedom of information) and I’ll include the link here for anyone who wants to read it. Perhaps someone who has more knowledge of how these studies are conducted could read it and explain it to us lay people…in my opinion from what I’ve read of it I wouldn’t give this to my dog but I’m interested to hear what those who can understand these studies have to say.
Also, what I found interesting (and shocking) is that here in Canada they had the drug company update the product information sheet based on the number of adverse reactions reported (twice…once before it was approved and once after) but that in some provinces vets are not required to share that information with pet owners! THAT is why it’s so important to research these things yourself. You really can’t depend on your vet to give you the information needed to make an informed decision (especially when the drug companies go to the vet clinics to push this drug!

https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/13959

rereading the article about the adverse reactions I wonder if you guys caught the part where Zoetis is now going to push vets to prescribe Librera for less severe forms of arthritis…

“And the company is encouraging vets to prescribe Librela more often, for moderate cases. This fall, the company’s “field force” is planning to visit vet clinics with that message”

We’ll soon see more adverse reactions if the number of dogs taking it increases.


Edward Bassingthwaighte, a veterinarian in Taradale, Australia, believes Librela should only be used as a last resort.

“There is no way in the world that I believe that Librela should ever be a first treatment for arthritis,” he said.

Dr. Bassingthwaighte has not prescribed the drug, citing concerns about the adverse reaction reports that pet owners around the world are sharing. He has also heard from other veterinarians who have observed animals’ physical mobility deteriorating after taking the drug.

“You get quite a large number of animals that will be okay with it, but you’ve got obviously a pretty heavy, sensitive tail of the bell curve that are not coping with it,” said Dr. Bassingthwaighte. “…I basically want people to understand that these drugs are not without risk. And I think the risk is being minimized.”
 
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Drug companies ALWAYS push for docs/vets prescribing drugs more often. (hello..oxy anyone?) and since most vets work for a corporate office now and have deals with online pharmacies if not run their own....

the updating drug sheet thing is quite common, actually. anything to avoid the dreaded 'black box'.

If there was a noticeable negative reaction after a few injections, it is also possible initial signs were missed because dogs can't tell us how they are feeling.
I will say that treating chronic conditions always has tricky problems with biologics as often they stop working after a time or side effect accumulate. long studies are needed to see what will happen as people or dogs are taking for months/years and not just 28 days or a few injection. Personally, if possible I'd stick with something where the human cognate has been approved for a while and has a good track record. This one has too many unknowns and the stories with dogs make one wonder if the human trials will actually end up in an approved drug.
 
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