vet says FDA pergolide better


Sharon Manning
 

Hi, my vet just left after being here and she mentioned to me the FDA approved pergolide that she has now to sell me is much better than the compounded pergolide that I get from Todds (Harvard park pharmacy) in Denver, CO. The compounded one I get, she says, is not stable and not pure therefore does not work as well as this new FDA approved that she sells. IS THIIS TRUE? I have two Cushings/IR horses and as I am sure you all know this "new drug" expense will be very hard to do and the pergolide from Todds is do-able... so unless there is truth in here statement I dont need the stress of yet another expense. She also says, you only need to give 1.0 mg of this "pure drug" where I now have my horse on 1.5. I would appreciate any advice and or information.
thanks
Sharon


Sherry Jackson <sherry@...>
 

Why don't you ask her for the peer reviewed information she has read to be
able to make such statements?



Sherry Jackson



From: EquineCushings@... [mailto:EquineCushings@...]
On Behalf Of SharonM
Sent: Tuesday, January 24, 2012 11:04 AM
To: EquineCushings@...
Subject: [EquineCushings] vet says FDA pergolide better





Hi, my vet just left after being here and she mentioned to me the FDA
approved pergolide that she has now to sell me is much better than the
compounded pergolide that I get from Todds (Harvard park pharmacy) in
Denver, CO. The compounded one I get, she says, is not stable and not pure
therefore does not work as well as this new FDA approved that she sells. IS
THIIS TRUE? I have two Cushings/IR horses and as I am sure you all know this
"new drug" expense will be very hard to do and the pergolide from Todds is
do-able... so unless there is truth in here statement I dont need the stress
of yet another expense. She also says, you only need to give 1.0 mg of this
"pure drug" where I now have my horse on 1.5. I would appreciate any advice
and or information.
thanks
Sharon


 

she mentioned to me the FDA approved pergolide that she has now to sell me is much better than the
compounded pergolide that I get from Todds<<
 
My vet said the same thing, but I told her that Tucker has been doing well with pergolide and I will stay with it. She wrote me a new prescription, but for 1.05mg. I don't have any scientific facts, but I would think it's true that the compounded ones are not as consistent as the FDA approved. However, I can't see paying more than twice the cost for FDA pills especially when Tucker's been doing fine with the compounded meds.
 
Besides, is the FDA pill only pills vs capsules? Capsules are easier to give.

Cynthia Boriskin from CA
Tucker 10/10


________________________________



[Non-text portions of this message have been removed]


Lorna <briars@...>
 

The compounded one I get, she says, is not stable and not pure >therefore does not work as well as this new FDA approved that she sells.
Hi Sharon,

I am copying here something from our Canada Sources file.
This was done last year when there were some ugly rumours abounding about quality control of compounded products.
It gives you an idea anyway.
I would ask my vet for her data which says the above.

"In November,2010, Island Pharmacy ( then known as Shawnigan Lake People's Pharmacy ), B.C., sent 15 capsules
from 2 lots of Pergolide Mesylate powder, to the lab for analysis, covering the powder that had been used over the last 6 months. They also sent both new and old capsules (capsulated for 3 months)
The lab results said they were stable and compounded 1mg Pergolide Mesylate capsules with a measured 0.949mg/cap which is where the USP guidelines says it should be for compounded medication."


By the way , can you add your location and date you joined the group to your signature when you post again?
It is helpful to know where people are so that we can speak to the issue which most closely addresses your concerns.

Thanks for your help.

Good luck with this situation.I know others will offer suggestions,too.

Lorna in Ontario,Canada
ECIR Moderator 2002
*See What Works in Equine Nutrition*
http://www.ecirhorse.com/images/stories/Success_Story_3_-Ollies_Story__updated.pdf


merlin5clougher <janieclougher@...>
 

Hi, Sharon -

So far, the data from the Prascend manufacturer has not impressed me very much with regard to being able to say that the Prascend is so much better than compounded pergolide capsules. (It will definitely be better than liquid, because liquid pergolide is so much less stable).

I have not seen any information that suggests that 1.0 mg of prascend is equal to the effect of 1.5 mg of compounded pergolide, so I would sure be careful dropping the dose if you do go that route.

But, to cut to the chase, the proof of the pudding is in the eating. Are your horses' ACTH controlled on their dose of compounded pergolide? Are they doing well? If the answers to those questions are "yes" and "yes", then I see no need to change.

Boehringer Ingleheim (the manufacturers of Prascend) are doing some very, very aggressive marketing, so we can expect to hear more of the "Prascend is more effective than...." hype.

Might be worth while to ask Todd's if they ever run potency checks on their pergolide, similar to what the Island Pharmacy on Vancouver Island did.

HTH.

Jaini(BVSc)Merlin,Maggie,Gypsy
BC09
EC Support


Hi, my vet just left after being here and she mentioned to me the FDA approved pergolide that she has now to sell me is much better than the compounded pergolide that I get from Todds (Harvard park pharmacy) in Denver, CO. The compounded one I get, she says, is not stable and not pure therefore does not work as well as this new FDA approved that she sells.
She also says, you only need to give 1.0 mg of this "pure drug" where I now have my horse on 1.5. I would appreciate any advice and or information.
thanks
Sharon


merlin5clougher <janieclougher@...>
 

Oops - forgot to mention that in Colorado, a vet is required to write a prescription at the client's request. Here is a list of states and the prescription protocols - just scroll down (I know it is a cat site)

http://tinyurl.com/3qqrkxy

However, with regards to sweetening up your vet in order to get the prescription, check out the info here (about halfway down the Pulling it Together folder, in "Getting your Veterinarian on Board"):

http://pets.groups.yahoo.com/group/EquineCushings/files/8%20Pulling%20it%20Together/


Jaini(BVSc)Merlin,Maggie,Gypsy
BC09
EC Support


Sg Levendusky
 

*Hi, my vet just left after being here and she mentioned to me the FDA approved pergolide that she has now to sell me is much better than the compounded pergolide *
 
My vet now refuses to write a prescription for compounded pergolide, saying that the FDA will not allow it.  My horse was doing well on the 1 mg powder from Thriving Pets.  It is difficult to tell if the Prascend is working, since it is the middle of winter.  Whatever the quality is, I doubt that it is three times better, since I am now forced to pay three times the cost for the drug.  I cannot afford to go up on her dose if it is needed.
 
Stacy and Star
2008 Angel Aalia
Georgia


Linda Rollins <lindarollins38@...>
 

Hi Stacy,

My horse was doing well on the 1 mg powder from Thriving Pets.
I cannot afford to go up on her dose if it is needed.

You may have to push those points with your vet. It's the old, "If it ain't broke, don't fix it." Your horse was doing well....Also, someone else correct me if I'm wrong, but your vet is incorrect in saying that the "FDA will not allow it."

You may need to find a new vet. Prascend is not "better" than compounded Pergolide, but it sure is way more expensive! Someone posted yesterday about stability testing on compounded pergolide. Let me see if I can find that, then you can print it out for your vet.

Linda
EC Support Team
Linda in MA, Peanut in RI now with Lavinia (he gets around)
9/07


Lorna <briars@...>
 

My vet now refuses to write a prescription for compounded pergolide, saying that the FDA will not allow it. 
Hi Stacy,

I believe what your vet means to say is that FDA will not allow the same 'dose' to be compounded.

In other words, you can have 1.05mg capsules.Or you can have 0.95mg capsules compounded , just for example.

But you cannot have 1mg capsules compounded,or strength of powder because Prascend is using the 1mg dose in their tablet.


Lorna in Ontario,Canada
ECIR Moderator 2002
*See What Works in Equine Nutrition*
http://www.ecirhorse.com/images/stories/Success_Story_3_-Ollies_Story__updated.pdf


Nancy C
 

Just wanted to let folks who may be having a pergolide discussion with their vet know of this link

Prescriptions -- Is your vet required to give you a prescription?
Created by an individual, but quite useful. Scroll to bottom of page for info & links by state.
<http://www.zzcat.com/CRF/supplies/legal.htm>

Nancy C in NH
ECIR Moderator 2003


NewEnglandEquineBalance@...

--- In EquineCushings@..., "Lorna" <briars@...> wrote:


In other words, you can have 1.05mg capsules.Or you can have 0.95mg capsules compounded , just for example.

But you cannot have 1mg capsules compounded,or strength of powder because Prascend is using the 1mg dose in their tablet.


Lorna in Ontario,Canada
ECIR Moderator 2002
*See What Works in Equine Nutrition*
http://www.ecirhorse.com/images/stories/Success_Story_3_-Ollies_Story__updated.pdf


Pamela Bramell
 

FWIW - I called my vet and explained the situation and he gladly called in a script for the 1.05mg (said he didn't want to go to lower dose since Frosty was doing well on 1mg) I had to call around to speak to some other vets regarding the ACTH test and also asked about the Prascend. One vet said no problem writing me a script and the other went on to rave about the Prascend. She then said that "I sound like I work for the drug company" followed up with a chuckle. You may have to do some homework and find a new vet that can work with you. I explained to the "drug company" vet that I would not be able to afford the Prascend and what happens when we have to up the dose. She said that they are believing that the Prascend won't have to be increased. Guess she either doesn't understand the disease progression or else she drank all of the kool-aid!
Pam/Butters/Frosty
12/10
Va.

--- In EquineCushings@..., Linda Rollins <lindarollins38@...> wrote:

Hi Stacy,

My horse was doing well on the 1 mg powder from Thriving Pets.
I cannot afford to go up on her dose if it is needed.

You may have to push those points with your vet. It's the old, "If


Linda Rollins <lindarollins38@...>
 

Also vexing is that Prascend is dosed by weight, not ACTH testing results:

http://www.prascend.com/Prescribe

Linda
EC Support Team
Linda in MA, Peanut in RI now with Lavinia (he gets around)
9/07


Sharon Manning
 

Intresting comments everyone!
I have two Cushings horses so I am looking at 165.00 per month compaired to 160.00 every three months! When talking to my vet and worrying that she was not going to renew my scrip....I called her back and told her I would try it on one of my horses (the one that dose is 1.0) and "IF" I saw a difference (improvement of some kind) then, of course, I would continue but "IF" not I would go back to the compounded. I will of course follow up with blood work too. Vet said, that was reasonable and fair. So, I think I got my bottom covered for a scrip in the future. My expectations? I am betting I will see no change because my mare Sugar seems to be doing fine with one exception. She is under weight. Before putting her on the compounded pergolide she dropped weight one winter and she developed terrible skin issues during the summer, the skin issues are much improved but not completely resolved so that will be a marker for me. If she gains weight and her skin issues completely resolve (with no other changes) then I will be sold on it otherwise I will be back on the less expensive product... What do you guys think of this approach? Does anyone know what Dr. K's thoughts are on this?
Sharon
East TN/USA
NRC+11/08
NAT 2/09
CIR12/09
DEW 08/10
COH 04/11


Eleanor Kellon, VMD
 

--- In EquineCushings@..., Sg Levendusky <aalegacyarabacres@...> wrote:

*Hi, my vet just left after being here and she mentioned to me the FDA approved pergolide that she has now to sell me is much better than the compounded pergolide *
We need everyone who makes the switch and tests before and after to please post their results.

There is an owner in my current Cushing's and IR Class who just posted her horse's ACTH of 209 in September on 3 mg of compounded pergolide went to 367 in January on 2 mg of Prascend for a month.

�
My vet now refuses to write a prescription for compounded pergolide, saying that the FDA will not allow it.�
That claim is very much up in the air, although the FDA lobbies heavily with the AAEP to push their opinions. The courts recently ruled against the FDA when they were trying to stop veterinary compounding from bulk drugs. The legal issues are complex, and include states' rights versus the FDA, but a major stumbling point for the FDA is that while they have issued multiple guidance documents/policy statements (basically "this is what we meant to say") but the language of the actual federal laws on this do not address veterinary compounding from bulk drugs. In other words, the letter of the law is not on the FDA's side.

Eleanor in PA
www.drkellon.com
EC Co-owner
Feb 2001


ianwiththrivingpets <ian@...>
 

Although veterinarians in half the states are required by law to provide you with a prescription for medically necessary treatments, they do not have to provide a prescription for the exact product and formulation you would like. For example, it is perfectly legal for a veterinarian to insist that you use Prascend rather than Pergolide Compound 1mg Capsules. Of course, it is within your rights to explain the benefits the compounded Pergolide, how it has worked well for your horse previously, and try to influence your vet's decision. But, in the end it is your vet's decision.

-Ian with ThrivingPets

p.s. I have already spoken with hundreds of veterinarians and hundreds of horse owners on this topic in the last 7 weeks. It seems like everyone is trying to figure out what to do and what their policy will be for Prascend and Compounded Pergolide.

--- In EquineCushings@..., "Nancy" <threecatfarm@...> wrote:

Just wanted to let folks who may be having a pergolide discussion with their vet know of this link

Prescriptions -- Is your vet required to give you a prescription?
Created by an individual, but quite useful. Scroll to bottom of page for info & links by state.
<http://www.zzcat.com/CRF/supplies/legal.htm>

Nancy C in NH
ECIR Moderator 2003


NewEnglandEquineBalance@...

--- In EquineCushings@..., "Lorna" <briars@> wrote:


In other words, you can have 1.05mg capsules.Or you can have 0.95mg capsules compounded , just for example.

But you cannot have 1mg capsules compounded,or strength of powder because Prascend is using the 1mg dose in their tablet.


Lorna in Ontario,Canada
ECIR Moderator 2002
*See What Works in Equine Nutrition*
http://www.ecirhorse.com/images/stories/Success_Story_3_-Ollies_Story__updated.pdf


Linda <PapBallou@...>
 

p.s. I have already spoken with hundreds of veterinarians and hundreds of horse owners on this topic in the last 7 weeks. It seems like everyone is trying to figure out what to do and what their policy will be for Prascend and Compounded Pergolide.

Hi Ian -

Have you found that your compounded pergolide Rxs have fallen off? Not wanting to get into your pharmacy business, but just wondering what is the current tone as far as willingness to stick with the compounded?

Thanks-

Linda
EC Primary Response
West Coast
May 2004


ianwiththrivingpets <ian@...>
 

Hi, Linda. I'm happy to share what is going on with Pergolide and Prascend. Yes, we are compounding significantly fewer Pergolide Capsules than we did 2 months ago. I'm not sure how much we are off but I would estimate about 30%. To date we have sent out 920 Prascend 1mg tablets.

-Ian with ThrivingPets

--- In EquineCushings@..., "Linda" <PapBallou@...> wrote:



p.s. I have already spoken with hundreds of veterinarians and hundreds of horse owners on this topic in the last 7 weeks. It seems like everyone is trying to figure out what to do and what their policy will be for Prascend and Compounded Pergolide.

Hi Ian -

Have you found that your compounded pergolide Rxs have fallen off? Not wanting to get into your pharmacy business, but just wondering what is the current tone as far as willingness to stick with the compounded?

Thanks-

Linda
EC Primary Response
West Coast
May 2004


tomtriv <ThePitchforkPrincess@...>
 

--- In EquineCushings@..., Linda Rollins <lindarollins38@...> wrote:

Also vexing is that Prascend is dosed by weight, not ACTH testing results:

http://www.prascend.com/Prescribe
Linda,
Do you know of any science data about using ACTH as the reason for choosing dosage? I know I based my assumption on both Dr. Kellon's course, and her post where she said "The only right dosage is the one that controls the ACTH" (or something very close to that). (See Dosage Considerations in the files http://tinyurl.com/yaj4g8w

If we can get some study behind this, it may help get their vets to understand that dosage should be based on ACTH not horse weight.

For now though a little non-science(?) evidence might persuade member's vets to stay with compounded? Another possible argument for using ACTH instead of weight to decide dosage is the Pergolide Dosage Database with it's dosage listing and the ACTH numbers provided in Case Histories.

Clearly Dawn is doing well on 7mg to 8mg and at 850 pounds or so, the weight thing is silly? Also since we know(?)PPID is a progressive disease, how on earth can a by weight dosage work? It isn't science but a pretty good argument against doing by weight.

In that link you provided, it says not to exceed 4mg. I assume that is because Pracend is supposed to be so much more potent than compounded pergolide. This is not always true! As Lorna mentioned in an email earlier the following is in the Canada section of our files (and will be cross referenced in the next ECIR Files Table of Contents document):

Island Pharmacy (then known as Shawnigan Lake People's Pharmacy ), B.C., sent 15 capsules from 2 lots of Pergolide Mesylate powder, covering the powder that had been used over the last 6 months, to the lab for analysis. They also sent both new and
old capsules (capsulated for 3 months) The lab results said they were stable and compounded 1mg Pergolide Mesylate capsules with a measured 0.949mg/cap which is where the USP guidelines says it should be for compounded medication.

...................
Also, what does it matter if the pergolide is less potent anyway? If ACTH is used to monitior effectiveness then the horse is doing better at a considerably cheaper price for meds.

Don't we already know that all pergolide comes from a small source(s?) in China? So unless pracend's pergolide is made somewhere else, why should it be any better????

For all the members out there trying to keep their costs down, I think this can happen. The above arguments might make a vet pause. The fact that they need only change 1mg to 1.1 mg or whatever, to keep you happy and them out of "trouble" with lawyers or whatever, might be enough to do it?
Vets probably hate the whole pergolide money grab as much as we do but we have to understand the whole story and get facts so we can help our vets feel okay about getting around using pracend. Lets face it, they invested a heck of lot to get their degrees and practices going. It is understandable that they'd want to protect themselves from litigation.

- LeeAnne ECIR Archivist
03/04 Newmarket, Ont
Are you in the Pergolide Database? http://tinyurl.com/yfahmda
ECIR Files Table of Contents: http://tinyurl.com/ydvj2ph

http://TakenForGraniteArt.webs.com


Eleanor Kellon, VMD
 

Ian,

Have you had your products tested for potency like the Canadian pharmacy did?

Eleanor in PA
www.drkellon.com
EC Co-owner
Feb 2001


Eleanor Kellon, VMD
 

--- In EquineCushings@..., "tomtriv" <ThePitchforkPrincess@...> wrote:

Linda,
Do you know of any science data about using ACTH as the reason for choosing dosage?
It's the same principle as monitoring insulin when trying to control IR. ACTH has always been used to monitor therapy and dosage, e.g.:

http://www.ncbi.nlm.nih.gov/pubmed/12465775

If we can get some study behind this, it may help get their vets to understand that dosage should be based on ACTH not horse weight.
Part of the confusion is that the Prascend dosage is by weight, based on the literature:

<http://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/UCM280354>

but that's a **starting** dose.

Don't we already know that all pergolide comes from a small source(s?) in China? So unless pracend's pergolide is made somewhere else, why should it be any better????
Not necessarily China, but it is all imported so you're right, the starting drug should be equivalent. Beyond that, it's a stability issue.

Eleanor in PA
www.drkellon.com
EC Co-owner
Feb 2001