Only six months after their first dressage competition, my 4-year-old Zweibrucker mare, DeLovely, and her 29-year-old rider, Lisa Seegar Brown, were named Adult Amateur Training Level Reserve Champions at the inaugural USDF National Dressage Finals, held Nov. 7–10 at the Kentucky Horse Park. As a bonus to an incredible year, the mare also took the Training Level Championship for the Zweibrucker registry, Rheinland Pfalz-Saar International.
The year had not begun auspiciously for me at Flying Changes Farm in Marietta, Georgia: I found myself without a rider to start my young horses. My regular rider recommended Lisa, who lived just down the road, to start DeLovely under saddle. Lisa agreed to ride the young mare a couple of days a week. To make sure all the basics would be covered, I also engaged her long-time riding instructor, Carolyn West, of Tryon, North Carolina, to monitor the training sessions.
The connection between Lisa and DeLovely was immediate—so much so that I asked her if she would be willing to ride the mare in the first Markel/USEF Young Horse Dressage Training Session of 2013. Scott Hassler, USEF Young Horse coach, thought DeLovely had good potential. More importantly, the bond between horse and rider that can elevate performance into artistry was evident, and I was optimistic about the possibilities.
Only a few weeks after the Young Horse Training Session, Lisa and DeLovely made their competition debut at the Foothills Equestrian Nature Center in Landrum, South Carolina, winning Training Level, Test 1 with a score of 70 percent. We were excited and impressed with DeLovely’s performance and ability to cope with the show environment. With this promising start, Lisa was eager to continue her partnership with DeLovely, and training began in earnest for a USDF-sanctioned show in Aiken, South Carolina, to be held at the end of May. To my delight, Lisa and DeLovely won all three classes, including two Training Level, Test 3 tests, with scores in the mid-70s.
Lisa remembers, “I was expecting to do well, but I didn’t expect to win all three classes. I rechecked my tests to make sure the math was right. DeLovely was only in training for six months. This was her first USDF show.That’s when I knew this little mare was going somewhere.”
At the next USDF show in Landrum a few weeks later, DeLovely again won the Training Level, Test 3 class with a 74.2 percent. At this point, Lisa began encouraging me to start thinking seriously about competing at the USDF Region 3 Championships in Conyers, Georgia, in October. Also in the plan was to qualify DeLovely for the Rheinland Pfalz-Saar International national championship award for Training Level, which would require obtaining a total of 10 high scores at Training Level.
Their streak continued: Lisa and DeLovely won another Training Level, Test 3 class at Landrum with a score of 75.2 percent and then won again two weeks later with a score of 75.8 percent. The Flying Changes team was going to the Region 3 Championships.
Lisa and DeLovely joined a group of several of Carolyn West’s students, known as Team West, for the trip to the championships. In a Training Level, Test 3 class of 53 riders, their beautiful, soft ride earned them a first-place score of 74.8 percent. This win qualified them for the USDF National Dressage Finals. The pair had earned the highest qualification score of any Training-Level competitors.
Our hope for the USDF National Dressage Finals was to finish in the top 10 out of 27 entries from across the country. Just qualifying to show at the nationals was such a thrill; we could be satisfied with last place.
We were met at the Kentucky Horse Park by frigid temperatures and a steady 20-mph wind. DeLovely’s shed row stall was fronted by heavy canvas tarps that whipped constantly, slamming against the posts. The limited training arenas were already scheduled for use, meaning DeLovely would not be ridden until Saturday, an hour before her first class, the USEF Training Level, Test 1 Adult Amateur/Open. On Sunday, the pair would compete in the USDF Adult Amateur Training Level Championship.
To Lisa, regardless of the outcome of the championships, the pair had already won: “Learning everything we could this year, scoring high in every show, then winning regionals—showing at nationals was a bonus. DeLovely wanted it just as much as I did, and that’s why we make a great team. I had confidence in her just as much as she had confidence in me.”
The Saturday ride was only the second time Lisa and DeLovely had shown at First Level, so they were happy to place third with a steady ride. Team DeLovely felt ready for the championship competition.
DeLovely was scheduled about midway through the Training Level entries, so we watched some of the early rides and were impressed with the quality of riding we saw. When DeLovely’s time came, she entered the indoor arena, made a square halt at X for her salute and, with Lisa gently urging her forward, embarked on a beautiful ride.
Before the pair even got out of the ring, the judges had posted their score of 71.3 percent, putting them in second place. We watched the last eight rides with fingers crossed, hoping against hope that the dream that began last spring when we all first came together would come to fruition on this frosty Kentucky day, and it did: DeLovely and Lisa brought home the second-place award from the USDF as the U.S. Adult Amateur Training Level Reserve Champion, securing the Training Level Championship for the Zweibrucker registry. I am very happy with the performance of this young mare and the wonderful riding of Lisa. We will continue working on the next level and hope to return to the national finals next year.
In the first half of 2014, FDA’s Center for Veterinary Medicine approved two new equine drugs—TILDREN manufactured by Ceva Sante Animale and OSPHOS manufactured by Dechra, Ltd.—intended to control the clinical signs of navicular syndrome, a common cause of forelimb lameness in horses. Below is a brief reference guide for equine veterinarians on both drugs. You can also find this information on the FDA website.
What are the active ingredients in TILDREN and OSPHOS and how do they work?
The active ingredient in TILDREN is tiludronate disodium, and the active ingredient in OSPHOS is clodronate disodium. Both belong in the bisphosphonate drug class and the exact mechanism of action in horses with navicular syndrome is unknown.
What are biophosphonates?
Bisphosphonates are a class of drugs commonly prescribed to prevent bone loss in people. While TILDREN and OSPHOS are not used for this purpose in horses, knowing how bisphosphonates work in people will help you better understand this drug class overall and especially the adverse reactions seen in horses.
Bones undergo constant turnover, with osteoblasts forming bone and osteoclasts resorbing it. In normal bone tissue, there is a balance between bone formation and bone resorption. But in diseased bone tissue, this balance is disrupted. Bisphosphonates inhibit bone resorption by encouraging osteoclasts to undergo cell death, leading to a decrease in the breakdown of bone.
Bisphosphonates preferentially “stick” to calcium and bind to it. Because most of the body’s calcium is stored in bones, these drugs accumulate to a high concentration only in bones. Bisphosphonates are incorporated into the bone matrix and are gradually released over months to years.
What are the precautions for biophosphonates?
As a class, bisphosphonates can cause gastrointestinal and renal toxicity. Higher blood plasma levels may increase the risk of toxicity. Because bisphosphonates are excreted by the kidneys, conditions that impair renal function may increase the blood plasma level and lead to more adverse reactions. It is not recommended to use bisphosphonates in horses with impaired renal function. Use caution if you give bisphosphonates along with other potentially nephrotoxic drugs, and be sure to monitor renal function.
Bisphosphonates can cause signs of colic in horses, including abdominal pain, discomfort and agitation. These colic signs usually occur shortly after the drug is given and may be associated with altered intestinal motility.
Bisphosphonates affect the blood plasma levels of some minerals and electrolytes, such as calcium, magnesium and potassium. The effects are immediate and can last up to several hours. Use caution when you give bisphosphonates to horses with conditions affecting mineral or electrolyte homeostasis (for example, hyperkalemic periodic paralysis or hypocalcemia) or conditions which may be worsened by hypocalcemia (for example, cardiac disease).
The safe use of either TILDREN or OSPHOS has not been evaluated in horses less than 4 years of age. The effect of bisphosphonates on the skeleton of growing horses has not been studied. Because bisphosphonates inhibit osteoclast activity and decrease bone turnover, these drugs may affect bone growth.
The safe use of either TILDREN or OSPHOS has not been evaluated in breeding horses or pregnant or lactating mares. Bisphosphonates have been shown to cause abnormal fetal development in laboratory animals. The uptake of bisphosphonates into fetal bone may be greater than into maternal bone, creating a possible risk of skeletal or other abnormalities in the fetus. Bisphosphonates may be excreted in milk and absorbed by nursing animals.
Increased bone fragility has been seen in animals given bisphosphonates at high doses or for long periods of time. Because bisphosphonates inhibit bone resorption and decrease bone turnover, the body may be unable to repair microdamage within a bone.
How do you administer TILDREN and OSPHOS?
Even though TILDREN and OSPHOS are in the same drug class, they have different routes of administration.
After reconstituting TILDREN with sterile 0.9% sodium chloride, you administer the drug by intravenous infusion into a jugular catheter slowly and evenly over 90 minutes to minimize the risk of adverse reactions. It may take two months to see the maximum effect.
You administer OSPHOS by intramuscular injection. The total volume should be divided equally into three injection sites. Similar to TILDREN, it may take two months to see the most clinical improvement.
For horses that initially respond to OSPHOS, but don’t maintain their clinical improvement for 6 months, you may re-administer the drug at 3- to 6-month intervals based on clinical signs. For horses that respond to OSPHOS and maintain their clinical improvement for 6 months, you should re-administer after clinical signs recur.
What are the contraindications for TILDREN?
Do not give TILDREN to horses with a known hypersensitivity to the active ingredient, tiludronate disodium, or to mannitol. Also do not use the drug in horses with impaired renal function or with a history of renal disease. Nonsteroidal anti-inflammatory drugs (NSAIDs) should not be used concurrently with TILDREN as this may increase the risk of renal toxicity and acute renal failure. While no safe window for the concurrent use of NSAIDS and TILDREN has been determined, it may be especially risky to give an NSAID from 48 hours before to 48 hours after treatment with TILDREN. Make sure you observe appropriate wash-out periods between NSAID and TILDREN administration and monitor blood urea nitrogen and creatinine values.
What are the contraindications for OSPHOS?
Do not give OSPHOS to horses with a known hypersensitivity to clodronate disodium.
What adverse reactions are caused by TILDREN?
In three field studies, adverse reactions in horses treated with TILDREN most commonly occurred during the 90-minute intravenous infusion or within four hours following the end of the infusion. The most common reaction was colic.
Expect about 30-45% of horses given TILDREN to show transient signs of colic. Hoses should be observed closely for four hours after treatment. Colic signs can last about 90 minutes and may be intermittent. In many cases, hand-walking may improve or resolve the colic signs. If a horse needs medical therapy, you should give non-NSAID treatments, as the concurrent use of an NSAID increases the risk of renal toxicity and acute renal failure.
In the field studies, adverse reactions occurring between four hours and one day after treatment included:
- Increased frequency of urination with or without increased drinking;
- Reduced appetite;
- Sore or stiff neck;
- Fever; and
- Uncomplicated colic. Colic was the most common reaction.
When giving TILDREN, you should advise owners of the potential for adverse reactions in the hours or days following treatment. Also tell owners to consult you before giving their horse any NSAID after treatment with TILDREN.
What adverse reactions are caused by OSPHOS?
In the effectiveness field study, adverse reactions in horses treated with OSPHOS usually began within two hours of treatment. The most common adverse reactions were discomfort, agitation, pawing and signs of colic.
When giving OSPHOS, you should advise owners to watch their horse for at least two hours after treatment for agitation, signs of colic, and other abnormal behavior such as head shaking and lip licking. If a horse seems uncomfortable or nervous or experiences cramping, tell the owner to hand-walk the horse for 15 minutes. Advise the owner to contact you if signs don’t resolve or if the horse displays other abnormal symptoms.
Read the package inserts for TILDREN and OSPHOS for a complete description of the contraindications, warnings, and precautions for each drug.
What should you do if a horse experiences an adverse reaction related to TILDREN or OSPHOS?
FDA encourages veterinarians to voluntarily report all adverse reactions (also called adverse drug experiences, or ADEs) related to TILDREN or OSPHOS. Please see How to Report an Adverse Drug Experience.
The drug sponsors for TILDREN (Ceva Sante Animale) and OSPHOS (Dechra, Ltd.) are required to submit to FDA all reports of adverse drug experiences that they receive. FDA reviews the reports to identify potential safety and effectiveness concerns that may not have been apparent at the time of drug approval. FDA conducts this post-marketing monitoring to make sure that TILDREN and OSPHOS continue to meet the required standards for safety and effectiveness established during the approval process.
Important information for your client
The package insert for TILDREN has a section called “Information for Owners” and the package insert for OSPHOS has a similar section called “Information for Horse Owners.” These sections may help you in your communication with clients regarding both drugs.
What are the benefits of using an FDA-approved equine drug?
A main benefit of using an FDA-approved equine drug is that you know the drug is safe and effective in horses when used according to the label. A second benefit is that the label is written specifically for horses and includes all necessary information, including associated risks, so you can use the drug safely and effectively in your patients.
FDA rigorously evaluates an animal drug before approving it. As part of the approval process, the drug sponsor must prove to FDA that:
- The drug is safe and effective for a specific use in a specific animal species;
- The manufacturing process is adequate to preserve the drug’s identity, strength, quality, and purity. The drug sponsor must show that the drug can be consistently produced from batch to batch; and
- The drug’s labeling is truthful and complete.
FDA’s role does not stop after the agency approves an animal drug. As long as the drug sponsor markets the animal drug, the agency continues to monitor:
- The drug’s safety and effectiveness. Sometimes, the agency’s post-approval monitoring uncovers safety and effectiveness issues that were unknown at the time of approval;
- The manufacturing process to ensure quality and consistency are maintained from batch to batch;
- The drug’s labeling to make sure the information remains truthful and complete; and
- The drug company’s promotional materials to make sure they are truthful and not misleading.
For more information
If you have questions or would like more information, please contact CVM’s Education & Outreach Staff at 240-276-9300 or AskCVM@fda.hhs.gov.