Tag - biorelease

FDA ALERT: Regumate, Matrix (altrenogest ORAL products) pose human health risk

As a compounding pharmacist and part time blogger, I’m subscribed to just about all of the FDA alerts related to drugs. The other day I received this email and it took me by surprise a little just because it mentions altrenogest, something I too compound with. As I read on though, none of the notification came as much of a shock. It relays the message that exposure to progestins (a form of progesterone, in this case: altrenogest is a synthetic progestin only approved for animal use – not human). The original FDA communication I received is below, including links to the FDA Alert.

Any female or male exposed to progestins can have adverse effects from that exposure. However, let’s keep in mind that more specifically, as the FDA notes here, is that this can especially be a problematic in teenage girls (their reproductive system). When you stop to think about it, Altrenogest is no different necessarily than any progestin-only birth control on the market, but remember this is for a HORSE (much larger than your average female teenager).

Many of these FDA approved products are made specifically to be readily and quickly absorbed through mucous membranes; skin exposure can mean a major disruption to a human female’s reproductive system. If proper precautions aren’t taken (i.e. wearing chemical resistant gloves, face shield and apron) this could mean detrimental health effects for anyone exposed. Whether administering to the horse directly, in their feed or even cleaning a stall that had Regumate sprayed on the feed; you must properly protect yourself or employees from exposure.

BETs two Altrenogest formulations: BioRelease Altrenogest 150 mg/mL and BioRelease Altrenogest 500 mg Microparticle are INJECTABLE forms of Altrenogest. Each are unique in their delivery system because of their long acting formulation (links to published research of these formulations below). Altrenogest 150 mg/mL is typically administered once every 2 weeks and our Microparticle formulation is given just ONCE a MONTH. Aside from the convenience, if theres a cost involved for administering the oral products daily this would also certainly cut labor costs as well.

Veterinarians typically use the Altrenogest 150 mg/mL as a progestin supplement for pregnancy maintenance while the Microparticle formulation is given once a month for estrus suppression. Aside from the cost difference, the once a month formulation (which is more expensive) also has a very low incidence of injection site reactions; which makes it ideal for use in horses DURING the race/show season.

In terms of safety, BOTH of our injectable formulations present the user with a much lower risk of exposure given the use of syringes and needles to administer the dose. There’s virtually no clean up (properly dispose of sharps in biohazardous waste) after it’s administered and a lower risk of our formulation being sprayed or splashed onto the human giving the injection.

Check out this PDF from Auburn on how to properly give an injection in a horse.

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FDA communication Received July 3, 2018:

FDA Animal Drug Safety Communication: FDA highlights potential health risks to people exposed to altrenogest products for horses or pigs

The U.S. Food and Drug Administration is alerting veterinary medical professionals, as well as those who work with horses and pigs, that a synthetic progesterone product commonly used in these animals may cause reproductive system disorders and other adverse effects in people who become exposed to the drug. The FDA is providing this alert because of the nature of the adverse events, some of which have occurred in teenage girls.

Altrenogest belongs to the class of drugs called progestins and is used to suppress estrus (commonly called “heat” or “season”) in mares (female horses), and to synchronize estrus in gilts (young female pigs). It is marketed under several brand names, including the equine products Regumate, Ovamed and Altren; and the swine products Matrix, Chronomate and Swinemate. The equine products are available via a veterinarian’s prescription and can be administered directly on the base of the mare’s tongue or on the mare’s feed. The swine products are available over-the-counter and are administered on a portion of the gilt’s feed. These liquid products may be administered to the animals on a daily basis for prolonged periods of time.

The agency has received 130 reports of accidental human exposure to altrenogest products between October 6, 1987 and May 30, 2018; 121 of those were for Regumate, approved in 1983, and nine reports were for Matrix, approved in 2003. Although the FDA has not received any reports for the other (generic) products, the agency’s alert includes these products because they are used in the same manner as Regumate and Matrix and on the same animal populations, and therefore have the same risk for adverse events.

Read entire article.

More Animal Health Topics


*Check out our published research:

Evaluation of Sustained Release Progestin Formulations in Mares
P. J. Burns D. L. Thompson, Jr, W. A. Storer, R.M. Gilley 

Evaluation of BioRelease Altrenogest LA 150 For Maintenance of Pregnancy in Mares
C.M. Morrow, D.V.M and P.J. Burns, Ph.D. 

Use of a Compounded Proprietary Long-Acting Progesterone Formulation for Maintenance of Pregnancy in Mares
D.K. Vanderwall, J.L. Williams and G.L. Woods 


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Once a week* ULCER ALTERNATIVE – BioRelease Omeprazole

RE-release of BioRelease Omeprazole, an ulcer alternative

This last quarter we started compounding our BioRelease Injectable Omeprazole; a single dose injection that lasts one week.* We always felt that this was an excellent formulation but stopped making it for a couple years while attempting to do more research. We learned some valuable information and decided to release it again. Now that it’s been out for several months we called the veterinarians who’ve ordered and dispensed (some of them being repeat clients) to see what they had to say about the compound. Out of the 150+ doses that we’ve dispensed, only a handful of veterinarians were available for comment, but we were pleased with what they had to say…

Out of the 2 horses injected we’ve seen great improvement; honestly, did not scope either horse but we’re very pleased with your compound. We did switch needles like instructed and saw a very minimal site reaction – Dr. Liebsch.

This touches on one of the lessons learned when we performed some of our research.  In order to minimize site reactions we recommend that the needle be changed prior to injecting into the horse. That is generally best practice for injections so the patient is getting a new sterile needle rather than one that has also breached the vial. We also learned that the injection site needs to be rotated from week to week.

My client was very pleased. After 3 doses of your BioRelease Omeprazole the horse’s colic has cleared. – Dr. C. Buchanan

This wasn’t the only veterinarian that made this comment.  A few other vets had noticed that it had an effect after just 1-2 doses and colic symptoms had completely abated.

I really appreciated the small volume to be injected... – Dr. C. Guardia

This particular veterinarian had used another injectable omeprazole formulation that had a much larger injection volume and chose not to purchase again because of a site reaction from that compound. Our injection volume is only 6 mL when reconstituted.

I was very impressed and pleased; used BioRelease Omeprazole on 4 horses and all responded very quickly. – Dr. A. Roberts

Thanks Dr. Roberts!

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Other Info about BioRelease Omeprazole

Omeprazole powder can quickly degrade when exposed to light and not held at refrigerated temperatures. BioRelease Omeprazole is shipped in two separate vials: one vial filled with BioRelease Omeprazole powder and the other BioRelease diluent. If you’ve used omeprazole in suspension form or another injection you may have noticed that it can turn purple (this is partly the reason it has always been branded using purple – including Prilosec capsules – which are purple!); this occurs when omeprazole is breaking down and it’s a sign of loss of stability of the formulation. Because we have it in two separate dark colored vials and require it to be refrigerated up until the time of injection, our formulation keeps it’s stability so you know you’re getting the dose your horse needs.

Proton Pump Inhibitors (PPIs), Omeprazole’s drug class, are typically only indicated for short-term use in both humans and non-human animals. We recommend using our injectable formulation for a maximum duration of 4 weeks. If further therapy is indicated we recommend switching to an oral formulation for maintenance dosing.

Continuous Improvement

Here at BET we’re always trying to innovate and improve our formulations, processes…and our customer’s experience! Give us a call to try our BioRelease Omeprazole and of course we’d love to hear your feedback. Alternatively, you could also order using our ONLINE PHARMACY!

*Based on unpublished data; R.H. Douglas, PhD, 2012. Available upon request; contact us!

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The BET difference: BioRelease Cabergoline improves PPID in retired horse

An email…

Every so often we receive emails letting us know how much someone likes our 30 day Altrenogest Microparticle compound for keeping their mare out of heat and what a difference they’re seeing in the horse. This most recent email though, we just had to share. One of our newest formulations is used in horses with PPID, BioRelease Cabergoline. It’s an injection that is given once every 2 weeks rather than a daily orally administered regimen. We were aleady aware of the difference a dopamine agonist can have on the symptoms associated with PPID but this particular case stuck out because of the drastic transformation presented.

I’ll let the email and pictures speak for themselves from here on out:



We started using the Cabergoline on my Danish warmblood Rowin in December. Rowin was imported from Europe. I also have another warmblood, a 22 year old Hanoverian cross, AJ. He was born and bred in Illinois. He’s been retired for a dozen years (lives outside 24/7) due to lameness issues. I was going to put him down this spring. (the pictures below are of AJ from April 20, 2018 – Before Cabergoline administration)












When my other horse, Row, was no longer responding to his therapy at the time, I switched him to Cabergoline. I gave them to AJ. Not much happened. Couldn’t bring myself to put him down. Rowin then had a stroke right before Easter so I decided to give AJ the shot too since I wasn’t sure what was going to happen with Row.

Attached are pictures from April this year and last year and then 3 weeks ago after 6 – 3/4cc injections. AJ has had no feed, supplements etc.. just grass and hay in the winter since he lives outside. I didn’t bathe him, work him; nothing other than the shedding blade. I haven’t sat on him in a couple years.  Since he’s been turned I used to sit on him a couple times a year but haven’t the last 2 years because he looked so poorly. I think these pictures speak volumes!! He looks amazing and other than the shot he has had nothing but pasture or hay. (the pictures below are of AJ from June 14, 2018 – AFTER Cabergoline administration)




I can’t thank you enough!!

– K.E.




Would you like to try BioRelease Cabergoline? Check out our ONLINE pharmacy!? Contact your veterinarian or feel free to contact us: 866-707-0998

We also have some published literature on our BioRelease Cabergoline Injection (CLICK HERE)

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