Librera side effects

[Piper's mom]

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.

Thank you so much for that information Cindy! So am I understanding correctly that the human form of these drugs have not yet been approved?

 

[Cindy]

They have not. they are/were still in clinical trials (so they haven't been submitted for approval yet). A company won't generally submit unless they think they can get approval. oddly, there was hold on the trials for a few years around 2017 (the US FDA imposed a hold on all clinical trials of NGF antagonists because of reports of rapidly progressive OA and of osteonecrosis (ON) among patients receiving these agents; subsequently, this hold was extended due to observations of autonomic nervous damage in preclinical models).

here's a paper on one of them that goes into efficacy and side effects. notice the numbers are in the hundreds of patients. Companies can file for approval after a well run phase II/III trial if they ask and answer the right questions. But usually they want to feel comfortable doctors will use it (ie. it is better than what's out there, better/easier dosing schedule, and/or better safety profile) so they can make money. <https://pmc.ncbi.nlm.nih.gov/articles/PMC7958114/>

there was a third as well, but it was dropped (I think it was an Eli Lily drug). a lot of the stuff I'm seeing is a few years old and mixed results.

From google: The bottom line was that the benefits of tanezumab didn't seem to outweigh the risks, and the prospects for winning regulatory approval were slim. The development of other NGF drugs — such as an experimental J&J drug, and Teva and Regeneron's fasinumab — have struggled in clinical trials due to safety concerns

Oh..and for anyone interested, I have worked in biotech for 25 years (mostly on biologics) and have a good grasp on how drugs work and general info on how clinical trials and the drug approval process work. I read papers like the above for work all the time so I can bottom line stuff for people.

 

[Ann]

Thanks for sharing your expertise here, Cindy. Much appreciated by those of us to whom it's all gobbledygook!!!

 

[Cindy]

I worked with (tangentially) a vet company that took human meds and made them for pets. They have a much shorter and cheaper approval process (much smaller research costs and the time invested in research can be months vs years), so with people willing to pay for these drugs its a no brainer.

But for perspective, OTC drugs Tylenol causes liver problems and ibuprofen stomach ulcers. There is a saying in the drug world that today aspirin wouldn't get approved (def not for OTC use). these are drugs that are great for acute use but the problems tend to show up with chronic use (daily). Rye's Syndrome (aspirin) wouldn't even show up in testing of aspirin until after adult approval and it moved down to kids. And with so few kids getting chicken pox with vaccines....it would only show up in kids with the flu... Today's FDA is very strict (who knows what will happen in 2025).