[QUOTE=gumshoe;7859321]
What Canadian omeprazole? From Abler? Horseprerace? What omeprazole do you think is Canadian?[/QUOTE]
I purchase it from a Canadian company but it is manufactured in India. Like lots of US drugs. Seriously not trying to be argumentative here. This is an interesting conversation about something that impacts a lot of us here. People want an alternative to being raked over the coals by Merill because we have no options.
[QUOTE=CindyCRNA;7859478]
People want an alternative to being raked over the coals by Merill because we have no options.[/QUOTE]
Merial.
Hopefully, we will have options in April. GastroGard goes off patent then 
I’m curious to see if the FDA goes after the compounding companies next. My favorite omeprazole is the omeprazole/ranitidine paste from Precision.
In the interest of clarity, neither horseprerace nor Abler are in Canada. I’ve seen it mentioned many times in the past. My orders from horseprerace arrive in Canada and I have to go do customs clearance myself. Abler comes by UPS and UPS does the clearance (at least that was the case with my last order).
Many other companies -claim- to be Canadian but they are not.
Saying they are Canadian may convey some trustworthiness to the U.S. market. I don’t care one way or the other, I know they aren’t Cdn and still order anyway.
[QUOTE=gumshoe;7859522]
In the interest of clarity, neither horseprerace nor Abler are in Canada. I’ve seen it mentioned many times in the past. My orders from horseprerace arrive in Canada and I have to go do customs clearance myself. Abler comes by UPS and UPS does the clearance (at least that was the case with my last order).
Many other companies -claim- to be Canadian but they are not.
Saying they are Canadian may convey some trustworthiness to the U.S. market. I don’t care one way or the other, I know they aren’t Cdn and still order anyway. :)[/QUOTE]
Very interesting! So the Abler stuff comes from India. Is that where the company is located? Still happy with the FDA testing on it, it’s at least the dose (actually 35% more) on the package. And someone on COTH checked the coating and it truly was buffered like it said it was. But that is interesting about the company location!
[QUOTE=CindyCRNA;7859647]
Very interesting! So the Abler stuff comes from India. Is that where the company is located? Still happy with the FDA testing on it, it’s at least the dose (actually 35% more) on the package. And someone on COTH checked the coating and it truly was buffered like it said it was. But that is interesting about the company location![/QUOTE]
Not 35% more, 11% more. Where did you get 35?
At any rate, I’ll be stocking up just in case. Ranitidine is not an option – doesn’t work for everyone, myself and my horse included.
[QUOTE=CrowneDragon;7859098]
I wouldn’t doubt that Merial is behind it, and why shouldn’t they be? They spent a fortune developing and marketing a very effective drug, and a bunch of fly-by-night backyard operations have sprung up and are hawking what they claim to be the basically same product or better, except you have no idea what is or isn’t in it or if it is safe or effective. These places are blatantly peddling drugs illegally, and in most cases are flat-out robbing people because the products don’t contain what they claim.
I do wish that Merial would work to bring the price of their omeprazole products down to a more affordable level, but there are other options available (like ranitidine), if GastroGard/UlcerGard are too expensive.[/QUOTE]
[QUOTE=Texarkana;7859343]It must be really cold where you are, because you are more contrary than usual. 
Yes, I have facts. They are called fees. And they are expensive. And you still pay application fees even if you are denied, which I don’t believe any of these companies ever applied.
I’m not saying the FDA is taking bribes. I’m not saying the FDA is extorting businesses. What I am saying is that the department loses money when there are non-regulated drugs out there. The FDA still has to do their job, but there is no money coming in off the product.[/QUOTE]
Merial paid their fees long ago, the FDA isn’t getting another dime from Gastroguard…
As far as any other company submitting an application, none of the counterfeit companies have… and they won’t, that’s how they make money. They avoid the FDA so they don’t have to do costly things like actually prove what they are making is what they say it is… and prove they can reliably make it…
If anyone actually went through the process to get something else approved, they would have to charge a lot more…
And the FDA is not getting rich off INAD applications either… They reason they are going after these folks is not money, it is because these folks are breaking the law…
These folks are selling counterfeit drugs illegally.
The job of the FDA is to crack down on these people.
Most of the time, they don’t bother with stuff like this as it is small potatoes compared to a lot of stuff. But it is getting out of hand.
Horse Prerace in particular is selling all kinds of crap, and some of what they sell is killing horses (I’m not talking omeprazole here). As long as people are willing to buy their stuff, they’ll keep doing it.
I wonder how the fda finds out about these companies and decides to investigate?
[QUOTE=LarkspurCO;7859842]
Not 35% more, 11% more. Where did you get 35?
At any rate, I’ll be stocking up just in case. Ranitidine is not an option – doesn’t work for everyone, myself and my horse included.[/QUOTE]
My apologies. I thought I read upstream Abler tested at 135% of the stated dose. I’ll take 111% too!
[QUOTE=CindyCRNA;7860128]
I’ll take 111% too![/QUOTE]
I work in the pharmaceutical manufacturing business and we have as a individual site of our entire company been working the past 4 years to achieve approval for an ANDA. It’s a lot of work, but good work. You cannot trust companies to ‘do the right thing’ on their own. There has to be oversight.
I wonder if you people would be singing a different tune if the result came back at 89%. Basically that is essentially the same thing. ALL drugs have potency limits that HAVE to be tested before the lots are released for sale.
I don’t know exactly what the limits are for omeprazole not having worked with it specifically but industry standards are generally 95% to 105%, 98% to 102%.
ANYTHING outside of either side of the range is a FAILURE. The fact that they sent out product at 111% means they either didn’t test it or didn’t care. Neither is an acceptable answer in my book and I would not use any product from a company that conducted themselves in that way. But to each their own.
[QUOTE=wendy;7859365]
I don’t think those fees go into the FDA’s pocket. They go into the general government revenues. FDA gets its operating budget from the government, not from the fees.
the vets can prescribe Previcox off-label, quite legally. Once a drug has been approved for sale, it’s ok to prescribe and sell. Vets and doctors don’t have to follow the labelling or the approved indications.[/QUOTE]
No they can’t, not if there is an approved drug formulation for equines.
It is against federal regulations for a veterinarian to prescribe or dispense the product Previcox®, labeled for use only in dogs, for use in horses because there is already a FDA-approved drug for use in horses (Equioxx®).
https://www.avma.org/KB/Resources/Reference/Pages/Previcox-for-Equioxx.aspx
[QUOTE=CindyCRNA;7859647]
Very interesting! So the Abler stuff comes from India. Is that where the company is located? Still happy with the FDA testing on it, it’s at least the dose (actually 35% more) on the package. And someone on COTH checked the coating and it truly was buffered like it said it was. But that is interesting about the company location![/QUOTE]
I have absolutely no idea where they are located. The address on their website takes me to a tiny island way off the eastern African coast!
[QUOTE=Aleuronx;7860140]
ANYTHING outside of either side of the range is a FAILURE. The fact that they sent out product at 111% means they either didn’t test it or didn’t care.[/QUOTE]
This is my issue, as well. And I have bought omeprazole from Abler years ago when I needed to have a horse on omeprazole for a long time (it didn’t work out, because this was pre-“pop rocks” and all you could get were pills, which the horse either wouldn’t eat or were destroyed by chewing), and I feel that out of the illegal companies they probably send out the best product (and in a bind, I would use them), but it is definitely not on par with the quality of GastroGard or UlcerGard and you have little assurance of what you are getting. I also worry about the enteric coating, because I’d like to be assured of what phthalates, acrylates, etc are in there. They may work well for timed release, but are they safe? Omeprazole should have a decent margin of safety (to make the over-dosing less scary), although I don’t know if anyone knows the long-term safety of higher doses. The scarier thing is that Abler also makes other things, including phenylbutazone which does not have a large margin of safety.
It is really unfortunate that the Merial drugs are so expensive, because not many people can afford $1000-3000 for 1-3 months of ulcer treatment. It is certainly more convenient than ranitidine that has to be given 3 times a day, but ranitidine is cheaper than even “pop rocks”, and is effective. I have bought it at Costco or Sam’s Club and have had good results with it.
[QUOTE=Aleuronx;7860140]
ANYTHING outside of either side of the range is a FAILURE. The fact that they sent out product at 111% means they either didn’t test it or didn’t care. Neither is an acceptable answer in my book and I would not use any product from a company that conducted themselves in that way. But to each their own.[/QUOTE]
It doesn’t necessarily mean they failed to test the product. Maybe the package is intentionally overfilled to account for some loss in administering the medicine in the horse’s feed. Horses drop feed, granules are left behind.
Drug manufacturers commonly overfill vials of injectable medications because it’s difficult to extract all of the contents into a syringe. Oral medication syringes also are overfilled to ensure the stated dose is administered.
LarkspurCO- Yes, mode of administration does get taken into account when testing. Uniformity of dosage tests that each syringe (for instance) is containing a repeatable amount that may in fact contain slightly more to account for product sticking within the syringe itself.
Potency testing is done by combining several (per appropriate testing method) individual doses, mixing and then weighing a specific amount to test against a prepared standard. This tests demonstrates exactly what the drug contains, not what each packet may have.
I’m not saying they didn’t test it, although they might not have. If they have tested it, they will have to include all that documentation in their response to the FDA warning letter as well as any batch records that demonstrate that they added the appropriate X amount of omeprazole API to the batch.
And to all not familiar with the FDA, something called a ‘Warning Letter’ while the wording may sound minor is not in fact so. Warning letters are bad juju, companies are bankrupted and shut-down after receiving warning letters.
My reading of the FDA letter leads me to believe that the overage was based on the stated label amount of 700 mg, not a “mg/g” uniform measurement. I would be surprised if they accounted for any loss because the granules don’t stick to the inside of the container.
Of course I don’t know what testing procedures they followed, but an 11% overage for an oral medication sounds about right to me:
"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 © of the FD&C Act [21 U.S.C. § 351©], in that its strength differs from that which it purports or is represented to possess.
AbGard is the paste: http://www.abler.com/gastric-ulcer-treatments/abgard
The FDA letter makes no specific mention of Abprazole (ie, “blue pop rocks”) other than listing it as one of their products.
Oh, right. Then the paste SHOULD contain more omeprazole than the label and I would still be surprised if overfill was accounted for in the testing. The FDA’s objective is to stop sales of the product in the US.
Again, this is talking about two totally different things. Amount of omeprazole per dosage and amount of omeprazole per the label claim.
Take these statements from the warning letters of two of the companies:
“Gastroade Xtra is sub-potent, at 36.3% of the label claim for potency.”
“Gastro37 OTC was also found to be sub-potent, at 82.8% of the label’s claim for potency, according to the FDA.”
Label claim and dosage are two different things. They’re talking about milligrams of drug in solution not milligrams of drug in the entire tube or packet. The actual CONCENTRATION of the drug mixture is off.
IE the Abgard paste states it is 6.15 grams of paste in a tube. Within that paste is 37% w/w of omeprazole paste. There are not 6.15 grams of omeprazole in that paste. It means that when tested the paste was ~41% w/w in the entire tube. Not that there was per say 6.20 grams in the tube so when dosed they get all of the 37% w/w paste that is desired.
All warning letters can be seen here at the FDA website, it’s public knowledge:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm
And I’m sure if anyone has questions they could contact this guy mentioned on the letters.
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.
Can’t say whether or not you’d get a response though.
So if Abler had tested at 101% and had fallen into allowable guidelines, would there still be a warning letter?
Of course. Abler is still BREAKING THE LAW by selling an untested and unregulated drug in the US.
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