# abler products



## HuT (18 May 2018)

Has anyone used Abler products to treat their horses ulcer?


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## SEL (24 May 2018)

Not for the initial treatment - that went through insurance with her supplies omeprazole. She's had a few problems since the insurance ran out and after spending £400 with the vets in more omeprazole I got some Abler sachets for back up.

I've used them for a week over winter when she had a flare up with reduced turnout. I don't think they are as effective as quickly as gastroplus, but they did seem to work.


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## ycbm (24 May 2018)

According to a letter which Popsdosh once quoted, they have been tested by the US Food and Drug agency and contain the right levels of omeprazole.

It is illegal to use them, but thousands do, and they work.


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## JillA (24 May 2018)

Yes. And told my vet. And he didn't have a panic attack! And it worked.
The law is open to interpretation TBH - it says you can import prescription drugs for personal use. If your own animal it could be regarded as that - or might not! And unless you are selling on, the law is very rarely enforced anyway.
IMO if you are unable to afford the very expensive versions here, it is better than nothing and leaving your horse to suffer. I do know someone who successfully treated their horse with Nexium, an over the counter form of esomeprazole, but it would require large quantities


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## ycbm (24 May 2018)

Ranitidine from eBay imported for personal use will also work at the right dose levels and in some horses is more effective than omeprazole.


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## popsdosh (25 May 2018)

ycbm said:



			According to a letter which Popsdosh once quoted, they have been tested by the US Food and Drug agency and contain the right levels of omeprazole.

It is illegal to use them, but thousands do, and they work.
		
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please dont miss quote what I drew attention to . That letter was about the legalities of using abler products and to do with regulators enforcement action against Abler as their products are not licenced full stop even within the countries they manufacture in , Dont twist it to suit your own agenda.


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## ycbm (25 May 2018)

popsdosh said:



			please dont miss quote what I drew attention to . That letter was about the legalities of using abler products and to do with regulators enforcement action against Abler as their products are not licenced full stop even within the countries they manufacture in , Dont twist it to suit your own agenda.
		
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You referenced a  letter from the US FDA to Abler demanding that they stop supplying to the US. In that reference, the FDA says that they had tested the drugs and that they fell within the accepted levels of active substance for a drug with a narrow therapeutic index.

Omeprazole does not even have a narrow therapeutic index. So the Abler product was tested by the US FDA and MORE THAN meets the standard required to be legally supplied in the US. 

I've been much happier about telling people the product is a good one ever since you posted, paradoxically, because you post to put people off it. 

It is illegal. No-one has ever been prosecuted in this country for using it. I know of vets who advise (quietly) their clients to buy it when they are uninsured for ulcers.  It works.




ETA here's the original reference

https://forums-secure.horseandhound.co.uk/showthread.php?741215-Abler/page6&p=13439177#post13439177


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## popsdosh (25 May 2018)

ycbm said:



			You referenced a  letter from the US FDA to Abler demanding that they stop supplying to the US. In that reference, the FDA says that they had tested the drugs and that they fell within the accepted levels of active substance for a drug with a narrow therapeutic index.

Omeprazole does not even have a narrow therapeutic index. So the Abler product was tested by the US FDA and MORE THAN meets the standard required to be legally supplied in the US. 

I've been much happier about telling people the product is a good one ever since you posted, paradoxically, because you post to put people off it. 

It is illegal. No-one has ever been prosecuted in this country for using it. I know of vets who advise (quietly) their clients to buy it when they are uninsured for ulcers.  It works.




ETA here's the original reference

https://forums-secure.horseandhound.co.uk/showthread.php?741215-Abler/page6&p=13439177#post13439177

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So lets be very clear here !  You admit its ilegal to import into the UK!  are you saying its legal to import into the US ?
Can you please tell me any country that it  holds a Licence in?  If not why dont they licence it? If you cant why is it ok to break veterinary medicines regulations ?


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## ycbm (25 May 2018)

popsdosh said:



			So lets be very clear here !  You admit its ilegal to import into the UK!  are you saying its legal to import into the US ?
Can you please tell me any country that it  holds a Licence in?  If not why dont they licence it? If you cant why is it ok to break veterinary medicines regulations ?
		
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I have always, always said that it's illegal.  

It's illegal.

It meets all the required standards for a legal product.

It works. 

Whether it's OK or not is for the individual buyer's conscience. My conscience would not trouble me much on this one, if I needed it, because of the outrageous price being charged for the licenced products.


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## popsdosh (25 May 2018)

I will put this up so others may be clear and I draw your attention to the second paragraph  as maybe that should be read rather than cherry pick what was a breach and in its own way shows a lack of manufacturing competence. Maybe others view it differently  ,not sure I would want to take a drug that was stronger than stated.

Mr. Lindsay Kotthoff
Abler, Inc.
P.O. Box 158
Corowa 2645 NSW Australia


Dear Mr. Kotthoff:


This letter concerns the marketing of several products including, but not limited to, AbGard, Abprazole, Abprazole Plus, Abler Omeprazole, AbButazone, AblerQuant, and AbFen by your firm, Abler, Inc. The U.S. Food and Drug Administration (FDA) reviewed your website at the internet address abler.com, where you promote and sell this product, and obtained and tested samples of your AbGard product.

We have determined that the above referenced products are intended for use in the mitigation, treatment, or prevention of disease in animals, which makes them drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)(B)]. Under the FD&C Act, drugs intended for use in animals require an approved new animal drug application unless they are generally recognized as safe and effective. As discussed below, we have determined that these drugs are not generally recognized as safe and effective, and are therefore unsafe under section 512(a)(1) of the FD&C Act [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)], because you are marketing them without approved new animal drug applications. In addition, the drug AbGard is adulterated under section 501(c) of the FD&C Act [21 U.S.C. § 351 (c)], as testing of the drug revealed that its strength differs from the strength stated on the label.

Statements on your website and product labeling that show these products are intended for use in the mitigation, treatment or prevention of disease in animals include, but are not limited to, the following:


AbGard
&#8226; " ... for treatment and prevention of equine ulcers ... "

Abprazole
&#8226; " ... for treatment and prevention of equine ulcers ... "

Abprazole Plus
&#8226; " ... for treatment and prevention of equine ulcers ... "

Abler Omeprazole
&#8226; " ... for prevention and treatment of Equine Gastric Ulcers Syndrome ... "

AbButazone
&#8226; " ... for the alleviation of inflammation and pain associated with musculoskeletal disorders in adult horses"

AblerOuant
&#8226; " ... for treatment and prevention of equine worms and parasites . .. "

AbFen
&#8226; " ... to treat parasites that can damage a horse's gastro-intestinal and respiratory tracts."

The above referenced products are only a sampling of the violative products you are currently marketing. Similarly, the above referenced claims are only a sampling of statements that demonstrate the intended uses of your products.

Because the above referenced products are intended to mitigate, treat, or prevent disease in animals, they are drugs within the meaning of section 201(g)(1)(B) of the FD&C Act [21 U.S.C. § 321(g)(1)(B)]. Further, these products are new animal drugs, as defined by section 201(v) of the FD&C Act [21 U.S.C. § 321(v)], because they are not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.

To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1]. The above referenced products are not approved or index listed by the FDA, and therefore the products are considered unsafe under section 512(a)(1) of the FD&C Act [21 U.S.C. § 360b(a)], and adulterated under section 501 (a)(5) of the FD&C Act [21 U.S.C. § 351 (a)(5)]. Introduction of an adulterated drug into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].

In addition, testing by FDA of samples of the drug AbGard revealed that the amount of active ingredient (omeprazole) in the drug did not correspond with the amount represented on the labeling. Specifically, the drug was found to be super-potent at 111.3% of the label claim for potency. The drug is therefore adulterated under section 501 (c) of the FD&C Act [21 U.S.C. § 351(c)], in that its strength differs from that which it purports or is represented to possess.

This letter is not intended to be an all-inclusive review of your products and their promotion. It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations. Failure to promptly connect the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.

You should notify this office, in writing, within fifteen (15) working days of the receipt of this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include any documentation necessary to show that correction has been achieved. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.

Please direct your response to Dillard H. Woody Jr., Supervisor, Post Market Compliance Team at the U.S. Food and Drug Administration with the Center for Veterinary Medicine, 7519 Standish Place, Rockville, MD 20855-2773. If you have any questions about this letter, please contact Dillard Woody at 240-276-9237.


Sincerely, 
/S/

Eric Nelson, Director
Division of Compliance (HFV-230)
Office of Surveillance & Compliance
Center for Veterinary Medicine


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## popsdosh (25 May 2018)

ycbm said:



			I have always, always said that it's illegal.  

It's illegal.

It meets all the required standards for a legal product.
		
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Interesting what leads you to make the above statement about standards? Their products are unlicenced or tested so how can you know.


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## ycbm (25 May 2018)

popsdosh said:



			Interesting what leads you to make the above statement about standards? Their products are unlicenced or tested so how can you know.
		
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This paragraph in that letter sounds dreadful, but actually it means that Abler's products were tested by the FDA and found to be spot on, except for omrazole. However, the measure given is still within the allowable range for a drug with a narrow therapeutic index. That means one which only works well at specific doses. Omeprazole is NOT an NTI drug and that dose variation is medically fine. 

'In addition, testing by FDA of samples of the drug AbGard revealed that the amount of active ingredient (omeprazole) in the drug did not correspond with the amount represented on the labeling. Specifically, the drug was found to be super-potent at 111.3% of the label claim for potency. The drug is therefore adulterated under section 501 (c) of the FD&C Act [21 U.S.C. § 351(c)], in that its strength differs from that which it purports or is represented to possess.'

So very kindly, the FDA have told us all that all the Abler drugs are effective and safe.

Illegal. 

Effective.

Safe.


The letter is several years old and Abler are still in business and, afaik, happily supplying customers in the US in spite of the FDA's threats.


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## ycbm (25 May 2018)

popsdosh said:



			I will put this up so others may be clear and I draw your attention to the second paragraph  as maybe that should be read rather than cherry pick what was a breach and in its own way shows a lack of manufacturing competence. Maybe others view it differently  ,not sure I would want to take a drug that was stronger than stated.

Mr. Lindsay Kotthoff
Abler, Inc.
P.O. Box 158
Corowa 2645 NSW Australia


Dear Mr. Kotthoff:


This letter concerns the marketing of several products including, but not limited to, AbGard, Abprazole, Abprazole Plus, Abler Omeprazole, AbButazone, AblerQuant, and AbFen by your firm, Abler, Inc. The U.S. Food and Drug Administration (FDA) reviewed your website at the internet address abler.com, where you promote and sell this product, and obtained and tested samples of your AbGard product.

We have determined that the above referenced products are intended for use in the mitigation, treatment, or prevention of disease in animals, which makes them drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)(B)]. Under the FD&C Act, drugs intended for use in animals require an approved new animal drug application unless they are generally recognized as safe and effective. As discussed below, we have determined that these drugs are not generally recognized as safe and effective, and are therefore unsafe under section 512(a)(1) of the FD&C Act [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)], because you are marketing them without approved new animal drug applications. In addition, the drug AbGard is adulterated under section 501(c) of the FD&C Act [21 U.S.C. § 351 (c)], as testing of the drug revealed that its strength differs from the strength stated on the label.

Statements on your website and product labeling that show these products are intended for use in the mitigation, treatment or prevention of disease in animals include, but are not limited to, the following:


AbGard
 " ... for treatment and prevention of equine ulcers ... "

Abprazole
 " ... for treatment and prevention of equine ulcers ... "

Abprazole Plus
 " ... for treatment and prevention of equine ulcers ... "

Abler Omeprazole
 " ... for prevention and treatment of Equine Gastric Ulcers Syndrome ... "

AbButazone
 " ... for the alleviation of inflammation and pain associated with musculoskeletal disorders in adult horses"

AblerOuant
 " ... for treatment and prevention of equine worms and parasites . .. "

AbFen
 " ... to treat parasites that can damage a horse's gastro-intestinal and respiratory tracts."

The above referenced products are only a sampling of the violative products you are currently marketing. Similarly, the above referenced claims are only a sampling of statements that demonstrate the intended uses of your products.

Because the above referenced products are intended to mitigate, treat, or prevent disease in animals, they are drugs within the meaning of section 201(g)(1)(B) of the FD&C Act [21 U.S.C. § 321(g)(1)(B)]. Further, these products are new animal drugs, as defined by section 201(v) of the FD&C Act [21 U.S.C. § 321(v)], because they are not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.

To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1]. The above referenced products are not approved or index listed by the FDA, and therefore the products are considered unsafe under section 512(a)(1) of the FD&C Act [21 U.S.C. § 360b(a)], and adulterated under section 501 (a)(5) of the FD&C Act [21 U.S.C. § 351 (a)(5)]. Introduction of an adulterated drug into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].

In addition, testing by FDA of samples of the drug AbGard revealed that the amount of active ingredient (omeprazole) in the drug did not correspond with the amount represented on the labeling. Specifically, the drug was found to be super-potent at 111.3% of the label claim for potency. The drug is therefore adulterated under section 501 (c) of the FD&C Act [21 U.S.C. § 351(c)], in that its strength differs from that which it purports or is represented to possess.

This letter is not intended to be an all-inclusive review of your products and their promotion. It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations. Failure to promptly connect the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.

You should notify this office, in writing, within fifteen (15) working days of the receipt of this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include any documentation necessary to show that correction has been achieved. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.

Please direct your response to Dillard H. Woody Jr., Supervisor, Post Market Compliance Team at the U.S. Food and Drug Administration with the Center for Veterinary Medicine, 7519 Standish Place, Rockville, MD 20855-2773. If you have any questions about this letter, please contact Dillard Woody at 240-276-9237.


Sincerely, 
/S/

Eric Nelson, Director
Division of Compliance (HFV-230)
Office of Surveillance & Compliance
Center for Veterinary Medicine
		
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Did you edit out the date for a reason?   2014.


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## ihatework (25 May 2018)

ycbm said:



			This paragraph in that letter sounds dreadful, but actually it means that Abler's products were tested by the FDA and found to be spot on, except for omrazole. However, the measure given is still within the allowable range for a drug with a narrow therapeutic index. That means one which only works well at specific doses. Omeprazole is NOT an NTI drug and that dose variation is medically fine. 

'In addition, testing by FDA of samples of the drug AbGard revealed that the amount of active ingredient (omeprazole) in the drug did not correspond with the amount represented on the labeling. Specifically, the drug was found to be super-potent at 111.3% of the label claim for potency. The drug is therefore adulterated under section 501 (c) of the FD&C Act [21 U.S.C. § 351(c)], in that its strength differs from that which it purports or is represented to possess.'

So very kindly, the FDA have told us all that all the Abler drugs are effective and safe.

Illegal. 

Effective.

Safe.


The letter is several years old and Abler are still in business and, afaik, happily supplying customers in the US in spite of the FDA's threats.
		
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I&#8217;m not going to try and argue that the products are &#8216;probably&#8217; reasonably effective and safe, if illegal.

But you cannot claim they definitely are. The reason being this company has chosen to bypass the legislations put in place to ensure they are safe and effective. Very expensive systems to ensure consistency in both the active product and any impurities. So you can&#8217;t be sure that whilst one batch is &#8216;good&#8217; the next meets those criteria. That is why companies like these can produce products cheaper.

You pay your money you take your chances. But at least be honest about it.

And BTW you haven&#8217;t always said it was illegal. I remember quite clearly you spouting off it was legal in the early days, until I and a few others kindly corrected you.


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## ycbm (25 May 2018)

ihatework said:



			Im not going to try and argue that the products are probably reasonably effective and safe, if illegal.

But you cannot claim they definitely are. The reason being this company has chosen to bypass the legislations put in place to ensure they are safe and effective. Very expensive systems to ensure consistency in both the active product and any impurities. So you cant be sure that whilst one batch is good the next meets those criteria. That is why companies like these can produce products cheaper.

You pay your money you take your chances. But at least be honest about it.

And BTW you havent always said it was illegal. I remember quite clearly you spouting off it was legal in the early days, until I and a few others kindly corrected you.
		
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I don't believe that I have ever said it was legal. Please correct me if you can find it and quote me. I've always known it was illegal and I would never, ever, say something was legal if it wasn't.  Either your memory has failed you or mine has. I don't think, on this issue, that it's mine. I think the only person on this site who has ever suggested that it was legal is JillA, and you may be confusing her posts with mine.


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## popsdosh (25 May 2018)

ycbm said:



			I don't believe that I have ever said it was legal. Please correct me if you can find it and quote me. I've always known it was illegal and I would never, ever, say something was legal if it wasn't.  Either your memory has failed you or mine has. I don't think, on this issue, that it's mine. I think the only person on this site who has ever suggested that it was legal is JillA, and you may be confusing her posts with mine.
		
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 I think you have a short and very selective memory and I can clearly recall you arguing as only you can that it was not illegal to import drugs on the internet.
Surely even you must question why they havent had any of their products licenced by any authority which would make their sales legit. Yet you feel it is morally correct for them to carry on supplying. As I said I will leave that letter and let others decide , I think you are totally misleading people by implying that the letter in any way suggests  that their products are safe and effective it is merely your spin on it as it suits your argument . So lets see if others think the same as you. Just for your information that letter may be 2014 and no I did not edit it out as there is no reason to. Even today it is still illegal to import the products into the USA as Abler refused to do as requested by the FDA.

Jilla knows her stance is at best misguided as under the animal medicines legislation only a Vet can prescribe prescription medicines . She would not only be breaking the law regarding importing it but also breaking the law by giving it to the horse.

This all started because you chose to mention my user name in support of your assumption ,where you twisted certain parts of that letter and I think thats pretty shabby behaviour at best and potentially plain inflammatory. If thats not the case why was I mentioned and I look forward to a plausible answer!  Im not arguing with you as lifes to short just giving others the information to make up their own minds if its a risk they are prepared to take.


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## ycbm (26 May 2018)

As I said PD. If you believe I have ever said importing Abler products was legal find it and prove it. To my own recollection, I never have. My own recollection is that I have known since day one that importing drugs for horses was illegal and I would never, ever, lie about that.


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## popsdosh (26 May 2018)

popsdosh said:



			This all started because you chose to mention my user name in support of your assumption ,where you twisted certain parts of that letter and I think thats pretty shabby behaviour at best and potentially plain inflammatory. If thats not the case why was I mentioned and I look forward to a plausible answer!  Im not arguing with you as lifes to short just giving others the information to make up their own minds if its a risk they are prepared to take.
		
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Im still waiting for an answer as to why my username was mentioned . Unless of course I am correct and you were fully aware of the reaction it would cause!


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## ycbm (26 May 2018)

popsdosh said:



			Im still waiting for an answer as to why my username was mentioned . Unless of course I am correct and you were fully aware of the reaction it would cause!
		
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Because you posted the link!


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## popsdosh (26 May 2018)

ycbm said:



			Because you posted the link!
		
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  really


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## ycbm (26 May 2018)

popsdosh said:



			Interesting what leads you to make the above statement about standards? Their products are unlicenced or tested so how can you know.
		
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They aren't untested. As the letter that the FDA sent to Abler shows, the FDA have kindly tested them for us. They found a discrepancy in omeprazole weight that was not clinically significant. They found nothing else wrong with any of the Abler products or that letter would have said so. I was very grateful to the FDA for confirming the safety of the products for us all, quite the reverse effect of what they were trying to achieve.


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## ycbm (26 May 2018)

popsdosh said:



  really
		
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Yes, really. It never crossed my mind that you would get upset about a previous post you made being mentioned.


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## popsdosh (26 May 2018)

ycbm said:



			They aren't untested. As the letter that the FDA sent to Abler shows, the FDA have kindly tested them for us. They found a discrepancy in omeprazole weight that was not clinically significant. They found nothing else wrong with any of the Abler products or that letter would have said so. I was very grateful to the FDA for confirming the safety of the products for us all, quite the reverse effect of what they were trying to achieve.
		
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Your still spinning it nowhere in that letter does it state they are safe and effective !In fact it is the contrary. As I say others can judge seeing the letter. 
There was only one product tested from Abler so please be clear about that . 
Please just dont use my username in future to try and back up something you are spinning and is clearly a misinterpretation of what was written.


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## ycbm (26 May 2018)

popsdosh said:



			Your still spinning it nowhere in that letter does it state they are safe and effective !In fact it is the contrary. As I say others can judge seeing the letter. 
There was only one product tested from Abler so please be clear about that . 
Please just dont use my username in future to try and back up something you are spinning and is clearly a misinterpretation of what was written.
		
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You think they only tested one product to see if they could catch them out?  They only reported the one because they could only find a problem with the one.  And that was a non-clinical issue. 

Use your user name as some sort of 'support'?  I think you are kidding yourself about how important anyone thinks your, or my, views are. I certainly have never used your user name intending to strengthen any argument of mine!


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## Snoozy (26 May 2018)

ycbm said:



			This paragraph in that letter sounds dreadful, but actually it means that Abler's products were tested by the FDA and found to be spot on, except for omrazole. However, the measure given is still within the allowable range for a drug with a narrow therapeutic index. That means one which only works well at specific doses. Omeprazole is NOT an NTI drug and that dose variation is medically fine. 

'In addition, testing by FDA of samples of the drug AbGard revealed that the amount of active ingredient (omeprazole) in the drug did not correspond with the amount represented on the labeling. Specifically, the drug was found to be super-potent at 111.3% of the label claim for potency. The drug is therefore adulterated under section 501 (c) of the FD&C Act [21 U.S.C. § 351(c)], in that its strength differs from that which it purports or is represented to possess.'

*So very kindly, the FDA have told us all that all the Abler drugs are effective and safe.*

Illegal. 

*Effective.

Safe.*

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ycbm said:



			They aren't untested. As the letter that the FDA sent to Abler shows, the FDA have kindly tested them for us. They found a discrepancy in omeprazole weight that was not clinically significant. They found nothing else wrong with any of the Abler products or that letter would have said so. *I was very grateful to the FDA for confirming the safety of the products* for us all, quite the reverse effect of what they were trying to achieve.
		
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You misunderstand. The FDA have absolutely not confirmed the efficacy or safety of the Abler products mentioned in their warning letter. To do that, they would have had to conduct efficacy and safety studies. They havent (neither have Abler, which is why I wouldnt give any of their products to my horses but thats by-the-by). The FDA ran a simple assay to confirm how much active ingredient the products contain vs what Abler claim they contain. And shown that one of them is adulterated. Which is totally unsurprising for an unregulated Indian(?) manufacturing facility.


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## popsdosh (27 May 2018)

ycbm said:



			You think they only tested one product to see if they could catch them out?  They only reported the one because they could only find a problem with the one.  And that was a non-clinical issue.
		
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See the problem is you obviously cannot see why the letters where sent and it wasnt just Abler.

It had nothing to do with 'catching them out' as they were already breaking the law the argument was Abler were trying to hide under the supplements route rather than admitting they are drugs under the regulations. So the letter deals with the legalities of what cannot be sold . Indeed not all products were tested as I hope this link 

https://stablemanagement.com/indust...etters-illegal-omeprazole-products-mean-26313 

may clarify to you and  going by other letters which can be researched all products that were tested were noted as so on the warning letters. The only reason any were tested was to actually test to make sure they contained illegal substances ie Omeprazole that was not licenced. I think you may have missed that reason for testing. It certainly wasnt to make sure they were safe as under the law none of them are so that would be pointless.


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## ycbm (27 May 2018)

PD omeprazole is omeprazole. The safety and efficacy of omeprazole in horses has already been fully tested. If the product contains nothing but omeprazole and the enteric coating, which it does because otherwise the FDA would have said it was contaminated, then it's safe. 

Yes, it's illegal. Thousands of people are using it. Vets are even recommending it. It's an over the counter medication in small doses, freely available on eBay in large doses. There does not appear to be any attempt by the authorities in the UK to prevent Abler from selling here. The US tried four years ago to prevent them from selling into the US and have failed. 

I'm not sure how far you think you are going to get with your one man crusade in the face of an overwhelming tide of happy customers.


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## popsdosh (27 May 2018)

ycbm said:



			PD omeprazole is omeprazole. The safety and efficacy of omeprazole in horses has already been fully tested. If the product contains nothing but omeprazole and the enteric coating, which it does because otherwise the FDA would have said it was contaminated, then it's safe. 

Yes, it's illegal. Thousands of people are using it. Vets are even recommending it. It's an over the counter medication in small doses, freely available on eBay in large doses. There does not appear to be any attempt by the authorities in the UK to prevent Abler from selling here. The US tried four years ago to prevent them from selling into the US and have failed. 

I'm not sure how far you think you are going to get with your one man crusade in the face of an overwhelming tide of happy customers.
		
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You are so blind the FDA labelled it as adulterated. As Stated above it was not tested to prove it was safe but merely to prove it was illegal to market ie: contained a controlled substance. You are fully aware im sure omeprazole is not blanket licenced and is merely a constituent of individual licenced products.You really cannot get your head around that letters point can you.
Yes you can buy omeprazole online and also from the same seller as the equine one however many of them are unlicenced as well maybe you would not be so quick shoving them down your own throat.

I have no problem with those using them ,however they should be made aware of what the implications are . Im very confident those using them who read the letter will come to the same conclusion as me as to its meaning .It certainly doesnt bother me if they carry on using it or not as long as they are aware of its position as the marketing of it does not draw your attention to the legalities.

I suggest YCBM if you think there is no effort to stop Abler marketing here you check out how often their website is offline and then check out the metadata of the routing which changes very regularly. I guess the address labels at import dont mention Abler or Animal medication either. The trouble is you just dont hear of the levels intercepted. They just resend if you dont receive what you order .


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## ycbm (27 May 2018)

Yes you can buy omeprazole online and also from the same seller as the equine one however many of them are unlicenced as well maybe you would not be so quick shoving them down your own throat.
		
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They're in my bathroom cabinet . I wouldn't give my horses anything I don't trust myself.




			They just resend if you don't receive what you order .
		
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They do. With no quibbles, and quickly. I don't know if you realise quite how much you are advertising this company and its products PD.


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## Tiddlypom (27 May 2018)

Far from being sucked in to Abler products, my bargepole is getting even longer .


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## HuT (30 May 2018)

popsdosh said:



			So lets be very clear here !  You admit its ilegal to import into the UK!  are you saying its legal to import into the US ?
Can you please tell me any country that it  holds a Licence in?  If not why dont they licence it? If you cant why is it ok to break veterinary medicines regulations ?
		
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I have spoken to them directly and they are going through licensing in Australia at present. But it is a very lengthy and expensive process (as with any drug licensing). From the little i know about vet products once it is licensed in one country and they have the evidence and information and testing etc... licenses in other countries will be much quicker and easier to achieve.


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## HuT (30 May 2018)

Can i get back to my original question! i wanted to know peoples personal experiences of using them. If you haven't used them can you kindly stop posting as i want to hear only from people that have?


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## HuT (30 May 2018)

ycbm said:



			PD omeprazole is omeprazole. The safety and efficacy of omeprazole in horses has already been fully tested. If the product contains nothing but omeprazole and the enteric coating, which it does because otherwise the FDA would have said it was contaminated, then it's safe. 

Yes, it's illegal. Thousands of people are using it. Vets are even recommending it. It's an over the counter medication in small doses, freely available on eBay in large doses. There does not appear to be any attempt by the authorities in the UK to prevent Abler from selling here. The US tried four years ago to prevent them from selling into the US and have failed. 

I'm not sure how far you think you are going to get with your one man crusade in the face of an overwhelming tide of happy customers.
		
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I agree and i am not sure why my question has attracted these answers. I just want to know peoples experiences of using them!


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## HuT (30 May 2018)

Snoozy said:



			You misunderstand. The FDA have absolutely not confirmed the efficacy or safety of the Abler products mentioned in their warning letter. To do that, they would have had to conduct efficacy and safety studies. They havent (neither have Abler, which is why I wouldnt give any of their products to my horses but thats by-the-by). The FDA ran a simple assay to confirm how much active ingredient the products contain vs what Abler claim they contain. And shown that one of them is adulterated. Which is totally unsurprising for an unregulated Indian(?) manufacturing facility.
		
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What makes you think they are manufactured in an unregulated indian facility?


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## popsdosh (31 May 2018)

HuT said:



			What makes you think they are manufactured in an unregulated indian facility?
		
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Sri Lanka actually and sent from Vanu Atu to circumvent all the regs.  They will tell you anything to sell you the drugs do not believe them on the getting regulated in Aus as its a relativeley quick and inexpensive exercise for a generic drug .  How many other companies  get away with marketing drugs under testing? Ask them why they try to fool you into thinking you are buying from the US? Just some more questions to ask when you call them up ! Your money your choice, but I guess the big moral question is if you want to buy knock off drugs which manufacturer is going to research new ones.


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## ycbm (31 May 2018)

HuT said:



			I have spoken to them directly and they are going through licensing in Australia at present. But it is a very lengthy and expensive process (as with any drug licensing). From the little i know about vet products once it is licensed in one country and they have the evidence and information and testing etc... licenses in other countries will be much quicker and easier to achieve.
		
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I wouldn't believe that unless the Australians tell you so, personally. But they do work!


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## HuT (31 May 2018)

They dont try and trick you into thinking they are in the US? well i dont think that at all.  Many drugs / products are manufactured in sri lanka including loads of Marks and Spencers products. Does that make them bad? With regards to licensing in Aus you are not correct. It is not a quick process.

The main point is i asked for feedback from people that use the products and you clearly dont. I think you perhaps should refrain from commenting further unless you have an experience of using them.


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## HuT (31 May 2018)

JillA said:



			Yes. And told my vet. And he didn't have a panic attack! And it worked.
The law is open to interpretation TBH - it says you can import prescription drugs for personal use. If your own animal it could be regarded as that - or might not! And unless you are selling on, the law is very rarely enforced anyway.
IMO if you are unable to afford the very expensive versions here, it is better than nothing and leaving your horse to suffer. I do know someone who successfully treated their horse with Nexium, an over the counter form of esomeprazole, but it would require large quantities
		
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Thank you this mirrors my thinking tbh. I think it is best to treat your horse and then leave them to suffer. I think if the other products were a reasonable cost then people would not look for alternatives. I have now bought and start the products and i think i can already see a difference. I also loved i got them on next day delivery and i payed with paypal so all safe in case they didnt arrive


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## ester (31 May 2018)

If you want to talk to people that have used it a lot seem to have on the 'horses with ulcers' group on facebook.


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## Snoozy (31 May 2018)

HuT said:



			What makes you think they are manufactured in an unregulated indian facility?
		
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I dont know if their manufacturing facility is located in India - it was a guess (hence the question mark) based on their head office being located in the Indian Ocean. 

As far as their manufacturing facility being unregulated - as none of their products are approved by the FDA, EMA, APVMA, etc, theyre unregulated. One of the products the FDA tested was adulterated so I dont think its unreasonable to assume the Abler manufacturing facility is not GMP compliant.


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## Cecile (31 May 2018)

Is this debate all about saving money on drugs?  If there is a drug licenced to be used in the UK why would anyone wish to buy a drug that has no licence?  You could potentially buy from a batch that is lethal as someone at the other end couldn't read the manual

I only have access to a BNF and PDR which obviously is all about the possible side effects/cautions with humans using Omeprazole with the fully licenced drugs handed out by medic's and it doesn't make pleasant reading - I wouldn't be messing about with unlicenced drugs for the sake of saving money with my horses, what people choose to stuff down their own mouths is fine by me but come on keep your horses as safe as possible, there really are no pockets in a shroud


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## HuT (31 May 2018)

Cecile said:



			Is this debate all about saving money on drugs?  If there is a drug licenced to be used in the UK why would anyone wish to buy a drug that has no licence?  You could potentially buy from a batch that is lethal as someone at the other end couldn't read the manual

I only have access to a BNF and PDR which obviously is all about the possible side effects/cautions with humans using Omeprazole with the fully licenced drugs handed out by medic's and it doesn't make pleasant reading - I wouldn't be messing about with unlicenced drugs for the sake of saving money with my horses, what people choose to stuff down their own mouths is fine by me but come on keep your horses as safe as possible, there really are no pockets in a shroud
		
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Again i asked for feedback form people that have used them. Not another lecture!


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## ester (31 May 2018)

Usually yes it is about saving money, as some find gastroguard prohibitively expensive, often when it is no longer covered by insurance and the horse relapses. As such I think some face the alternatives of allowing their horse to live in pain with ulcers, or PTS and I can kind of understand that the risk may then be worth it to them. It is at least why abler have been successful enough to keep on going. 

I do find it interesting that it did all blow up a bit with the FDA but it went very quiet after that letter.  

Interestingly merial also supply an alternative product in the USA to gastroguard, it is called ulcergard, is available OTC and the only difference is the marketing (ulcergard marketed as a preventative, to enable the OTC status)


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## ycbm (31 May 2018)

Cecile said:



			Is this debate all about saving money on drugs?  If there is a drug licenced to be used in the UK why would anyone wish to buy a drug that has no licence?
		
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Because the difference is hundreds of pound a week and thousands of people use it worldwide and there isn't, I think, a single report of a  problem with any horse that's been given it. I've had two horses on Abler drugs myself many years ago and I know of plenty that are on them right now.


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## popsdosh (31 May 2018)

Ester what I find so amazing is that although people accuse Merial of raking in profits obviously others do not feel the the need to partake of this as only Norbrook have actually brought another to market in the UK even though Gastroguard has been off patent since 2014 . In the equine market of course the enteric coating is the important bit as the horses stomach has a different PH to humans so this is were the research went in and may be the reason some have reported that Ablers products have not worked whereas GG had.
Just being devils advocate I would suggest that Abler actually earn higher profits from their versions as they have suffered no regulatory or licencing costs . So maybe thats not such a valid reason to use Abler.


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## ycbm (31 May 2018)

HuT said:



			Again i asked for feedback form people that have used them. Not another lecture!
		
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You're on an open forum, you can't dictate who can post what, sorry.


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## ycbm (31 May 2018)

popsdosh said:



			Just being devils advocate I would suggest that Abler actually earn higher profits from their versions as they have suffered no regulatory or licencing costs . So maybe thats not such a valid reason to use Abler.
		
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Have you actually seen the price difference? Hundreds of pounds a week, per horse.

Merial were given a twenty year licence to recoup their development costs. At the end of that twenty years, the price should have dropped markedly. I don't believe it did, in which case then they are, by definition, making a whacking great profit on it now.


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## ester (31 May 2018)

Yes and Norbrook don't make it much cheaper which I think is quite telling (because in my limited experience of their other products there can be quite a big difference). 

I do know some vets suggest the abler route if the owner does not have another option, equally I do wonder what happens if you don't think the abler has worked so you get your horse scoped, how that conversation with the vet goes, or whether so many are doing it the vets are used to it.


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## ester (31 May 2018)

ycbm said:



			Have you actually seen the price difference? Hundreds of pounds a week, per horse.
		
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The price difference doesn't mean anything re. profitability unless you know the costs of production and supply?


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## ycbm (31 May 2018)

ester said:



			The price difference doesn't mean anything re. profitability unless you know the costs of production and supply?
		
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If the original cost for twenty years of licence covered development costs, then by definition, if the price remains the same after the development costs have been recouped, provided the cost of manufacture has not risen, (and why should it because in that time it has also become a human OTC medication)  then they are now making a killing on it. 

I know you like to defend drug companies Ester but they are no more saints than any other retailers. Have you seen the price of wormers in other countries compared with the UK?  You can't even buy an identical wormer from the same manufacturer in this country for the price they are sold for in the US, Australia or France, last time I looked.


Macclesfield is Astra Zeneca town and the OH has consulted for their finance department in the past. We have loads of friends who work or worked for them. . We know how their money is earned and spent when they get a drug that's a cash cow. The sports facilities at the Head Office complex in Alderley (before relocation to Cambridge) had to be seen to be believed.


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## popsdosh (31 May 2018)

ycbm said:



			Have you actually seen the price difference? Hundreds of pounds a week, per horse.

Merial were given a twenty year licence to recoup their development costs. At the end of that twenty years, the price should have dropped markedly. I don't believe it did, in which case then they are, by definition, making a whacking great profit on it now.
		
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However if they are making whacking profits where are the Others as theres nothing stopping them! You are not given a licence to recoup your development cost it is standard industry practice and pricing is down to the manufacturer and I repeat only one other has bothered to try and get in on this highly lucrative market . The only way cost will drop is if there is competition and as Ester rightly says Norbrook are renowned for coming in well below others and havent in this case. Abler will be 20% cheaper just because your not being charged VAT if you take that into account the hundreds a week is a bit of an exageration it is well below a hundred when judged like for like, around £45 if buying at the best prices you can.


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## ester (31 May 2018)

I thought you were directly comparing the profit achieved per dose by merial, and the profit achieved per dose by abler. As we don't know what abler spend on production we don't know their profit, it could be more than what merial are making.

I don't defend drug companies, or consider them saints, they are there for the shareholders. But I also consider that we would be totally screwed for new drug development without some of the current regs surrounding their production/licensing etc. Anthelmintic development being a good current case in point.


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## ycbm (31 May 2018)

popsdosh said:



			However if they are making whacking profits where are the Others as theres nothing stopping them! You are not given a licence to recoup your development cost it is standard industry practice and pricing is down to the manufacturer and I repeat only one other has bothered to try and get in on this highly lucrative market . The only way cost will drop is if there is competition and as Ester rightly says Norbrook are renowned for coming in well below others and havent in this case. Abler will be 20% cheaper just because your not being charged VAT if you take that into account the hundreds a week is a bit of an exageration it is well below a hundred when judged like for like, around £45 if buying at the best prices you can.
		
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Hundreds a week is a bit of an exaggeration. The comparison is gastrogard with abler omeprazole. 

Gastrogard £150 a week for a 575-kg horse

Abler under £45 for the same dose.

Saving for the typical treatment course of 4 full weeks  4 half weeks over £600

Yet again PD, you're doing a great job of raising Abler's profile as a supplier of ulcer meds!


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## popsdosh (31 May 2018)

ycbm said:



			Hundreds a week is a bit of an exaggeration. The comparison is gastrogard with abler omeprazole. 

Gastrogard £150 a week for a 575-kg horse

Abler under £45 for the same dose.

Saving for the typical treatment course of 4 full weeks  4 half weeks over £600

Yet again PD, you're doing a great job of raising Abler's profile as a supplier of ulcer meds!
		
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Unlicenced and adulterated according to the FDA.WHY?
 You keep forgetting that .


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## ycbm (31 May 2018)

I don't forget it at all. Unlicensed. Illegal.

Adulterated?  Depends on your definition of that word. The only adulteration identified by the FDA was 10% less in the dose than advertised, which is still within the therapeutic index for effective use for that particular drug. That's a trading standards nicety, not a safety issue.


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## popsdosh (31 May 2018)

ycbm said:



			I don't forget it at all. Unlicensed. Illegal.

Adulterated?  Depends on your definition of that word. The only adulteration identified by the FDA was 10% less in the dose than advertised, which is still within the therapeutic index for effective use for that particular drug. That's a trading standards nicety, not a safety issue.
		
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So being unlicenced with no control over production methods is not a SAFETY ISSUE! you astound me sometimes!!!  Antifreeze contains alchohol  does that make it safe to drink?

Again the product was not tested beyond establishing it contained a controlled drug that was the only purpose so as to send the warning letter. You seem to have a mental block on that.


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## JillA (31 May 2018)

ycbm said:



			You're on an open forum, you can't dictate who can post what, sorry.
		
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That's a bit harsh - I can see OPs point of view and almost posted about that myself a few pages back. She wants experiences, and quite possibly knows the pros and cons. without everyone giving their hobby horses an outing!
For what it's worth, the high price Gastro Guard has been able to sustain is largely down to insurance companies - they don't have to count the pennies, they just hike premiums. So we all pay. For those of us who self insure, that sort of price is hard to accept


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## ester (31 May 2018)

ycbm said:



			I don't forget it at all. Unlicensed. Illegal.

Adulterated?  Depends on your definition of that word. The only adulteration identified by the FDA was 10% less in the dose than advertised, which is still within the therapeutic index for effective use for that particular drug. That's a trading standards nicety, not a safety issue.
		
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11.3% more


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## ihatework (31 May 2018)

ycbm said:



			Because the difference is hundreds of pound a week and thousands of people use it worldwide and there isn't, I think, a single report of a  problem with any horse that's been given it. I've had two horses on Abler drugs myself many years ago and I know of plenty that are on them right now.
		
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How the hell can you know that when Abler don&#8217;t follow industry standard pharmacovigilance procedures? Which is kind of the point trying to be made!
So unless you know every horse treated with Abler (which I doubt even you could lay claim to).

At the end of the day this is a knock off product, made in Asia, not compliant with GMP and PV, that has a few years ago been tested by the FDA and shown at that point in time and for that batch, to have active drug product within it. Abler has stayed in business and has presumably plenty of repeat business without Internet horror reports doing the rounds. Feeding it to a horse is significantly cheaper then giving gastroguard. But each time you do so you are doing it at a much higher risk to the animal than you would be feeding gastroguard.

To repeat - you pay your money you take your chances.

But don&#8217;t BS proven safety and efficacy


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## ester (31 May 2018)

JillA said:



			That's a bit harsh - I can see OPs point of view and almost posted about that myself a few pages back. She wants experiences, and quite possibly knows the pros and cons. without everyone giving their hobby horses an outing!
For what it's worth, the high price Gastro Guard has been able to sustain is largely down to insurance companies - they don't have to count the pennies, they just hike premiums. So we all pay. For those of us who self insure, that sort of price is hard to accept
		
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The thing is I don't think we have that many people who have used it, or will say they have used it on the forum, which is why I suggested elsewhere.


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## popsdosh (31 May 2018)

ycbm said:



			I don't forget it at all. Unlicensed. Illegal.

Adulterated?  Depends on your definition of that word. The only adulteration identified by the FDA was 10% less in the dose than advertised, which is still within the therapeutic index for effective use for that particular drug. That's a trading standards nicety, not a safety issue.
		
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'Legalisation would allow testing and quality control and, better monitoring of users who cause themselves harm '

My attention was brought to this quote which I assume you completely agree with!


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## HuT (31 May 2018)

ester said:



			The thing is I don't think we have that many people who have used it, or will say they have used it on the forum, which is why I suggested elsewhere.
		
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I dont think there will with people commenting /bullying people who ask a genuine questions and turning it into something it was not.

 The posters obviously have some issue with each other / abler and i dont blame anyone for not wanting to get dragged into their debate. Shame really as the point of forums is to ask questions, share experiences and information etc...


I also suspect after reading pages on facebook like Horse Ulcer Treatment and Information and Horses with Ulcer that there will be many more people than you think on here that have used them.

Just for anyone reading i have ordered the product from the UK (on the recommendation of others) and got them the next day. I have been using them and my horse is already showing signs of improvement! good luck to anyone struggling with their horses ulcers and in my opinion the products are definitely worth a try


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## ycbm (31 May 2018)

popsdosh said:



			'Legalisation would allow testing and quality control and, better monitoring of users who cause themselves harm '

My attention was brought to this quote which I assume you completely agree with!
		
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Of course. 

Is there a single case where a horse has been caused harm by abler products?

I don't count them 'not working' after one cycle and Gastrogard then working after one, as many horses need prolonged treatment. My friend's a horse has had three rounds of licenced ulcer meds and is seemingly incurable.  I also don't count any cases before the tablets and granules were enteric coated as they are now. 

If you can point me to harm caused, I'll never use their products again.


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## Hallo2012 (31 May 2018)

have to say i know LOADS of people using Abler and no horses have ever had a bad reaction to it and it definitely works as demonstrated by the many horses known personally to me that improve on it, deteriorate off it etc.

whether its illegal to import or not, wont stop me using it, i couldnt afford the alternative long term!


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## popsdosh (31 May 2018)

ycbm said:



			Of course. 

Is there a single case where a horse has been caused harm by abler products?

I don't count them 'not working' after one cycle and Gastrogard then working after one, as many horses need prolonged treatment. My friend's a horse has had three rounds of licenced ulcer meds and is seemingly incurable.  I also don't count any cases before the tablets and granules were enteric coated as they are now. 

If you can point me to harm caused, I'll never use their products again.
		
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What about testing and QC?


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## popsdosh (31 May 2018)

Hallo2012 said:



			have to say i know LOADS of people using Abler and no horses have ever had a bad reaction to it and it definitely works as demonstrated by the many horses known personally to me that improve on it, deteriorate off it etc.

whether its illegal to import or not, wont stop me using it, i couldnt afford the alternative long term!
		
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Sorry if you have to use long term you should be looking at your management rather than using drugs. More and more is getting known of the long term disadvantages which is why they are prescription meds.


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## ester (31 May 2018)

I do always worry about those using them long term, and wonder if the stomach just upregulates in response?


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## Casey76 (31 May 2018)

ycbm said:



			Because the difference is hundreds of pound a week and thousands of people use it worldwide and there isn't, I think, a single report of a  problem with any horse that's been given it. I've had two horses on Abler drugs myself many years ago and I know of plenty that are on them right now.
		
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There cant be any reports of adverse reactions, because there is no one to report them to as the product is unlicensed in the UK...

If your horse did have an adverse reaction, you would have absolutely no come back, no recompense, and it would be entirely upon your own head... and potentially invalidate any insurance you have.


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## ycbm (31 May 2018)

Casey76 said:



			There cant be any reports of adverse reactions, because there is no one to report them to as the product is unlicensed in the UK...

If your horse did have an adverse reaction, you would have absolutely no come back, no recompense, and it would be entirely upon your own head... and potentially invalidate any insurance you have.
		
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Of course there can be reports. Anyone who has an adverse reaction would report it on social media, including here. I've never seen one.


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## ycbm (31 May 2018)

popsdosh said:



			What about testing and QC?
		
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What about them?  I don't believe Abler want to poison their many thousands of customers' horses. You can believe that if you want to, no problem.


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## ester (31 May 2018)

ycbm said:



			Of course there can be reports. Anyone who has an adverse reaction would report it on social media, including here. I've never seen one.
		
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I'm not sure everyone would report it, because they would have to be brave enough to potentially face the ramifications of using an unlicenced medication on their horse and they might not feel robust enough for that.


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## ycbm (31 May 2018)

ester said:



			I'm not sure everyone would report it, because they would have to be brave enough to potentially face the ramifications of using an unlicenced medication on their horse and they might not feel robust enough for that.
		
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Of course everyone wouldn't report it, but there isn't, after many years of trading, a single report I know of anywhere whatsoever.


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## ester (31 May 2018)

ok I probably took your post too literally as you did say anyone would report it.


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## ycbm (31 May 2018)

ester said:



			ok I probably took your post too literally as you did say anyone would report it.
		
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I'm sorry Ester that was a typo error, I didn't even realise I had written would, not could.


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## ester (31 May 2018)

that makes more sense  I was just thinking bloody hell I wouldn't face the wrath of FB!


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## Hallo2012 (1 June 2018)

popsdosh said:



			Sorry if you have to use long term you should be looking at your management rather than using drugs. More and more is getting known of the long term disadvantages which is why they are prescription meds.
		
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to be clear its sucralfate for hind gut issues we use long term and there are so many complicating factors, grass, weather, as well as feed and management but thanks for your concern..................out of all the horses we have had 2 had ulcer issues (both ex racers so more than likely had them from well before we had them) and one died of an auto immune disease of which ulcers were a symptom. all the others are/were fine.

the implications of sucralfate long term are HUGELY different to omeprazole.


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