[flyracing]

Has anyone been told by their vet that it's illegal to write a script for the compounded Pentosan since the non-compounded form is available? I've never heard of this and am scratching my head.

No, because that's not true. There is no FDA approved Pentosan, period. It is only an "approved" drug in Australia. There is no non-compounded form available in the US (importing doesn't count). Pentosan is not even considered a medical device in the US so we really are skirting the rules with this one.

I give kudos to a vet willing to not sell or write a script for it, but at the same time "everybody's doing it", so it just makes that vet out to be the bad guy in the eyes of clients.


As a side note, I would prefer the FDA take a more middle ground stance on approving certain veterinary drugs (like injectables that are composed of what is already in the body). A system to keep the costs lower to drug companies and expidite the process while still providing some protection to the animals by way of purity assurance and at least safety studies (with efficiency studies to follow in a more cost effective manner).

[deltawave]

There is no FDA approved Pentosan, period.

Yes there is. But it is only used orally for bladder problems, not joints, and it is marketed as Elmiron. It can be (and occasionally is) also used in the injectible form.

http://en.wikipedia.org/wiki/Pentosan_polysulfate

[davistina67]

Wow, finally an article that backs up what vets have told me and what I got slaughtered for on year like a year ago that it is illegal for a vet to script or sell Pentosan! Although I admit I did not have a good way to explain it back then.

[BuddyRoo]

If I were a veterinarian and a client was asking me to sell them a drug for off label use, I wouldn't be too keen to script it out externally to my clinic pharmacy for fear of losing my license.

[ponygirl]

Well, I was originally talking to the vets office staff so there was something lost in translation. He was more than willing to call in a script for me but wanted me to know A) he had PentAussie in his clinic B) that he has had clients either like or hate Pentosan- no middle ground and C) that some have reported discoloration of the skin surrounding the injection site.

[deltawave]

Off-label or extra-label use is when veterinarians are allowed to use drugs that are not FDA-approved for equine medicine. Off-label use applies only if those drugs are FDA-approved for use in another species or for a different disease or route of administration.

Since Pentosan is FDA-approved, in a different form, for a different species, it is therefore acceptable for off-label use on the order of a licensed veterinarian. Using drugs off label is NOT illegal, NOT unethical, and is commonplace. What is being discussed in the article does not apply to Pentosan, strictly speaking, as it *IS* FDA APPROVED IN THE USA. The others are far more questionable.

[davistina67]

Since Pentosan is FDA-approved, in a different form, for a different species, it is therefore acceptable for off-label use on the order of a licensed veterinarian. Using drugs off label is NOT illegal, NOT unethical, and is commonplace. What is being discussed in the article does not apply to Pentosan, strictly speaking, as it *IS* FDA APPROVED IN THE USA. The others are far more questionable.

DW, do you think the article is getting at that Pentosan is illegal to write? Or what is your take on Pentosan regarding the article?

[Watermark Farm]

I just ordered a 100 ml bottle from Wedgwood, cost out the door was $168.

Vet A refused to write me a scrip. Said he would only sell me PentAussie as he feels it's a better product and he never prescribes compounded injectables.

Vet B wrote me the scrip, and he gets his from Wedgewood.

I've noticed that the PentAussie seems a lot more viscous than the compounded. Why would this be?

Also, having given both PentAussie and compounded Pentosan to the same horse, I feel like I saw more results with PentAussie. That said, I'm at $20/dose with compounded, and nearly $45 with PentAussie...

[flyracing]

DW, I did not know species crossing was allowed. That's actually a bit scary! Safety in one species does not mean safety in another!

[deltawave]

Species crossing is allowed. Otherwise kiss the Prascend and innumerable orher human drugs that are used on horses goodbye.
It is the burden of the prescribing practitioner to weigh these pros and cons and get INFORMED consent from the patient or client before using drugs off label. It is not rare, the use of drugs off label. I'll wager the informed consent discussion IS rare, however.

[deltawave]

DW, do you think the article is getting at that Pentosan is illegal to write? Or what is your take on Pentosan regarding the article?

My take is that Pentosan is fine, as long as the guidelines of not marking it up are followed. Pentaussie is NOT the same as Pentosan so you really can't argue that there is an identical brand name product there. I suppose it could be argued that the human product should br substituted (vis-a-vis the compounding issue) but I'm pretty sure the FDA has bigger fish to fry there.

[Chezzie]

I've noticed that the PentAussie seems a lot more viscous than the compounded. Why would this be?

They are not the same product. The PentAussie contains glucosamine in addition to pentosan.

[vxf111]

They are not the same product. The PentAussie contains glucosamine in addition to pentosan.

I think it's confusing given that Pentosan and PentAussie sound and even look so similar. I always have to do a double look and remind myself which is which. But, yes, the PentAussie is what's in Pentosan AND additional glucosamine. So those are two different products.

[davistina67]

My take is that Pentosan is fine, as long as the guidelines of not marking it up are followed. Pentaussie is NOT the same as Pentosan so you really can't argue that there is an identical brand name product there. I suppose it could be argued that the human product should br substituted (vis-a-vis the compounding issue) but I'm pretty sure the FDA has bigger fish to fry there.

I agree. I think the article is getting at that it is illegal to write Pentosen but since you said there is an FDA approved on the human side that would mean you could compound it to inject into another species but at that point the vet also assumes all liability if the horse drops dead!

[deltawave]

at that point the vet also assumes all liability if the horse drops dead!

If there is documentation of informed consent, including a discussion that the drug is compounded, is being used off label, and that there are risks with ALL drugs, then the liability is assumed by the horse's owner. A bad outcome, with appropriate informed consent and a reasonable standard of care (which I personally think could be demonstrated with the use of this drug), is not malpractice. Crap happens, and it is not always someone's "fault".

[vxf111]

This is part of why vets go to school, to make educated decisions about things like off label drug prescription. Yes, I want my vets to exercise that judgment. I want to be informed of the risks, but I also don't want my horses to suffer unnecessarily when there's a drug that could benefit them and my vet believes it is appropriate under the circumstance.

[deltawave]

I agree. Given the realities in the life of the average horse, joint problems are a very serious thing. A horse who can't work is not always assured of a cushy retirement or disability checks. And I believe that a majority of owners and vets who are contemplating these drugs are genuinely trying to do the right thing by the animals. (I'm leaving out anyone who is just trying to wring another race or another weekend of showing out of an unsound animal)

But I do think it's important that we treat these things as DRUGS, with definite potential risks, and not simply start using them willy nilly or for the heck of it.

[lillysb]

I just got my February edition of Horse Journal, where there was an article on Pentosan, which I just ordered from Wedgewood for my horse. The article warns of using injectable compounded meds, and my order is already on the way. Has anyone had any unpredicted bad reactions to using this? Thanks.

[deltawave]

You can do a search on this forum--the topic has been discussed in great detail on a number of threads.

[katyb]

No reactions here - 8 doses in, I think.