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No 'recipe' for fixing restricted motion
Vol 7 Issue 2 2017
Tips for Improving Survival in the Colicky Horse Final Rule to Protect Against Soring Abuses Technician Update: Managing Significant Trauma
Table of Contents
No 'Recipe' for
4 Rehabbing Restricted Equine Motion
Cover photo: Shutterstock/ Netfalls Remy Musser
FDA Regulates Stem Cell Products for Animals.................................................................. 8 colic
Looking Inside: Tips for Improving Survival in the Colicky Horse............................12 technician update
Managing Significant Trauma in a Senior Paint Gelding................................................16 News
USDA Publishes Final Rule to Provide Greater Protection for Horses................................ 3 FDA Ban on Powdered Medical Gloves Applies to Veterinary Use ..........................15 Significant Remodeling Seen in Aortic Rupture in Friesans...........................................15 advertisers Shanks Veterinary Equipment.................................. 3 Merck Animal Health.................................................. 5 Standlee Premium Western Forage ........................ 7
Merial.............................................................................. 9 Equinosis......................................................................13 AAEVT............................................................................15
Equine Vet Sales: Matthew Todd • ModernEquineVet@gmail.com Editor: Marie Rosenthal • email@example.com Art Director: Jennifer Barlow • firstname.lastname@example.org contributing writerS: Paul Basillo • Kathleen Ogle COPY EDITOR: Patty Wall Published by PO Box 935 • Morrisville, PA 19067 Marie Rosenthal and Jennifer Barlow, Publishers percybo media publishing
Issue 2/2017 | ModernEquineVet.com
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USDA Publishes Final Rule to Provide Greater Protection for Horses The Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued a final rule in January to eliminate the inhumane practice of horse soring—a practice primarily used in the training of Tennessee Walking Horses, racking horses and related breeds to accentuate the horse's gait. Soring uses chemicals or mechanical devices that irritate or blister a horse's forelegs to exaggerate the gate, which cause pain and distress, the agency said. An Inspector General’s audit found that APHIS’s program, which allowed the industry to police itself, did not adequately enforce the Horse Protection Act (HPA) to ensure that animals are not abused. The practice of soring continues among Tennessee Walking Horses.
ing the HPA be issued to any individuals who are responsible for: showing a sore horse; exhibiting a sore horse; entering or allowing the entry of that horse in a show or exhibition; selling, auctioning or offering the horse for sale or auction; shipping, moving, delivering or receiving a sore horse with reason to believe that such horse was to be shown, exhibited, sold, auctioned or offered for sale. This includes the manager, trainer, rider, custodian, seller or owner of the horse, as applicable. An individual who is suspended will not be permitted to show or exhibit any horse or judge or manage any horse show, horse exhibition or horse sale/auction for the duration of the suspension. The American Association of Equine Practitioners and the American Veterinary Medical Association, among others, have spoken out against soring. MeV
Radiograph courtesy of USDA
Lifting Large Animals Since 1957
X-rays of sored horses may show surplus nails or screws added to increase the weight carried by the hoof or place pressure on the sole.
Horse industry organizations and associations will no longer enforce the regulator provisions of the HPA. The USDA will train and license third-party horse protection inspectors (HPIs) to enforce the rule, which will go into effect next year. Horse shows, exhibitions, as well as sales and auctions that inspect horses, will have to appoint an HPI to inspect the horses after Jan. 1, 2018. A farrier will also be required onsite if more than 150 horses are entered, or be on call if there are fewer than 150 horses. Although the inspection rules do not begin until 2018, the prohibition of all action devices, except for certain boots, will be prohibited beginning 30 days after publication in the Federal Register, which is expected soon. Pads and wedges will be prohibited after Jan. 1, 2018, unless they have been prescribed for therapeutic purposes. Because inspections and enforcement will be consistent throughout all shows, the final rule should ensure a level playing field for competitors. This final rule requires that suspensions for violat-
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Recipe for Rehabbing Restricted Motion?
There Is None B y
In the not-too-distant past,
Wedge block being used to stretch the deep digital flexor tendon during rehabilitation of a tendon injury. Courtesy of Dr. Steve Adair at the University of Tennessee, College of Veterinary Medicine, Equine Performance and Rehabilitation Center https://equinerehab.utk.edu
equine physical therapy consisted mostly of 30 days in the stall, 30 days in the paddock and 30 days in the pasture. With the successes in human physical therapy and the similarities now being drawn between human and equine athletes, more veterinarians are opting for a thorough approach to horses with restricted joint motion. “There are many techniques out there,” said Steve Adair, DVM, DACVS, DACVMS, here at the 62nd AAEP Annual Convention in Orlando. “Veterinarians need to look at the techniques and develop them on an individual basis. There is no ‘cookbook.’ We cannot do the same thing for every patient.” When researching rehabilitation facilities for referral, it is important to remember that most are unregulated. Protocols are often prescribed by nonprofessional staff. The staff may be knowledgeable horse people, but they often do not have a veterinary medicine background.
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P a u l
B a s i l i o
There are some exceptions, but in many cases, a veterinarian is not likely to be on staff. In addition, the efficacy of many modalities is unknown. Success can be demonstrated in patients with restricted joint motion, but often the data are lacking, he warned.
A simple massage of the joint can be beneficial, particularly in patients with edema. Massage has been shown to improve lymphatic drainage and can loosen tissue around a restricted joint. “Stretching is also one of the biggest things I can do for restricted joint motion,” said Dr. Adair, associate professor of equine surgery at the University of Tennessee, College of Veterinary Medicine. “It’s not only beneficial for the appendicular skeleton, but for the axial skeleton as well.” The amount of pain will dictate the intensity of the flexion and oscillation of the joint.
“I use a lot of heat,” Dr. Adair said. “I think it does a great job prior to stretching, mobilization, or exercise. It makes the tissue more pliable, and often makes the exercise more effective.” Dr. Adair will often use cryotherapy with acute injuries and after exercise.
Lasers and Electromagnets
Low-level laser therapy (LLLT) has been shown to heal skin wounds, stimulate blood and lymphatic systems, increase serotonin levels and improve vasodilation, among other effects. All of these can assist in healing. “I use [LLLT] after exercise, stretching, or mobilization, in lieu of cold,” Dr. Adair said. “I use it primarily in the acute stage.” Pulsed electromagnetic therapies are used primarily for pain relief. There is some evidence supporting the analgesic effects of this modality, and it has also been
The Science of Convenient Protazil® (1.56% diclazuril) is the only FDA-approved alfalfa-based top dress antiprotozoal pellet for the treatment of EPM. • Equine Protozoal Myeloencephalitis (EPM) is a serious neurological disease that can strike anytime, anywhere. Make treatment easy with Protazil® • Safe and accurate dosing with a calibrated scoop • Easier to use than paste, less stress for you and your horse • Rapid absorption — no loading dose required1 Now that’s convenient.
Ask your veterinarian for Protazil®. Visit us at Protazil.com to learn more about Merck Animal Health and the equine products and programs that help keep horses healthy. Use of Protazil® (1.56% dicazuril) is contraindicated in horses with known hypersensitivity to diclazuril. Safe use in horses used for breeding purposes, during pregnancy, or in lactating mares has not been evaluated. The safety of Protazil® (1.56% dicazuril) with concomitant therapies in horses has not been evaluated. See related page in this issue for details. For use in horses only. Do not use in horses intended for human consumption. Not for human use. Keep out of reach of children.
The Science of Healthier Animals 2 Giralda Farms • Madison, NJ 07940 • merck-animal-health-usa.com • 800-521-5767 Copyright © 2016 Intervet Inc., d/b/a/ Merck Animal Health, a subsidiary of Merck & Co., Inc. All rights reserved. 3526 EQ-FP AD Protazil®
Hunyadi L, Papich MG, Pusterla N. Pharmacokinetics of a low-dose and DA-labeled dose of diclazuril administered orally as a pelleted top dressing in adult horses. J of Vet Pharmacology and Therapeutics (accepted) 2014, doi: 10.111/jvp.12176. The correlation between pharmacokinetic data and clinical effectiveness is unknown
Orthopedics ANTIPROTOZOAL PELLETS
FOR ORAL USE IN HORSES ONLY For the treatment of equine protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona in horses. CAUTION Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian. NADA #141-268 Approved by FDA DESCRIPTION Diclazuril, (±)-2,6-dichloro-α-(4-chlorophenyl)-4-(4,5 dihydro-3,5-dioxo-1,2,4-triazin-2(3H)-yl) benzeneacetonitrile, has a molecular formula of C17 H 9 CI 3 N4O2, a molecular weight of 407.64, and a molecular structure as follows:
improve bone density. Studies have shown that within 29 days of stall confinement, horses will experience a significant loss of bone density. “Fifteen to 20 minutes twice daily has been shown to be efficacious in humans,” he explained. “It has also been shown to improve neuromuscular activity in humans. The problem is that you have to exercise while on the plate [for those effects]. I have not figured out how to get a horse to do squats while on a vibration plate.”
Diclazuril is an anticoccidial (antiprotozoal) compound with activity against several genera of the phylum Apicomplexa. PROTAZIL® (diclazuril) is supplied as oral pellets containing 1.56% diclazuril to be mixed as a top-dress in feed. Inert ingredients include dehydrated alfalfa meal, wheat middlings, cane molasses and propionic acid (preservative). INDICATIONS PROTAZIL® (1.56% diclazuril) Antiprotozoal Pellets are indicated for the treatment of equine protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona in horses. DOSAGE AND ADMINISTRATION Dosage: PROTAZIL® (1.56% diclazuril) is administered as a top dress in the horse’s daily grain ration at a rate of 1 mg diclazuril per kg (0.45 mg diclazuril/lb) of body weight for 28 days. The quantity of PROTAZIL® necessary to deliver this dose is 64 mg pellets per kg (29 mg pellets/ lb) of body weight. Administration: To achieve this dose, weigh the horse (or use a weigh tape)). Scoop up PROTAZIL® to the level (cup mark) corresponding to the dose for the horse’s body weight using the following chart: Weight Range of Horse (lb) 275 - 524 525 - 774 775 - 1024 1025 - 1274
mLs of Pellets 20 30 40 50
Weight Range of Horse (lb) 1275 - 1524 1525 - 1774 1775 - 2074 -
mLs of Pellets 60 70 80 -
One 2-lb bucket of PROTAZIL® will treat one 1100-lb horse for 28 days. One 10-lb bucket of PROTAZIL® will treat five 1100-lb horses for 28 days. CONTRAINDICATIONS Use of PROTAZIL® (1.56% diclazuril) Antiprotozoal Pellets is contraindicated in horses with known hypersensitivity to diclazuril. WARNINGS For use in horses only. Do not use in horses intended for human consumption. Not for human use. Keep out of reach of children. PRECAUTIONS The safe use of PROTAZIL® (1.56% diclazuril) Antiprotozoal Pellets in horses used for breeding purposes, during pregnancy, or in lactating mares has not been evaluated. The safety of PROTAZIL® (1.56% diclazuril) Antiprotozoal Pellets with concomitant therapies in horses has not been evaluated. ADVERSE REACTIONS There were no adverse effects noted in the field study which could be ascribed to diclazuril. To report suspected adverse reactions, to obtain a MSDS, or for technical assistance call 1-800-224-5318. CLINICAL PHARMACOLOGY The effectiveness of diclazuril in inhibiting merozoite production of Sarcocystis neurona and S. 1 falcatula in bovine turbinate cell cultures was studied by Lindsay and Dubey (2000). Diclazuril inhibited merozoite production by more than 80% in cultures of S. neurona or S. falcatula treated with 0.1 ng/mL diclazuril and greater than 95% inhibition of merozoite production (IC 95 ) was observed when infected cultures were treated with 1.0 ng/mL diclazuril. The clinical relevance of the in vitro cell culture data has not been determined. PHARMACOKINETICS IN THE HORSE The oral bioavailability of diclazuril from the PROTAZIL® (1.56% diclazuril) Antiprotozoal Pellets at a 5 mg/kg dose rate is approximately 5%. Related diclazuril concentrations in the cerebrospinal fluid (CSF) range between 1% and 5% of the concentrations observed in the plasma. Nevertheless, based upon equine pilot study data, CSF concentrations are expected to 2 substantially exceed the in vitro IC 95 estimates for merozoite production (Dirikolu et al., 1999) . Due to its long terminal elimination half-life in horses (approximately 43-65 hours), diclazuril accumulation occurs with once-daily dosing. Corresponding steady state blood levels are achieved by approximately Day 10 of administration. EFFECTIVENESS Two hundred and fourteen mares, stallions, and geldings of various breeds, ranging in age from 9.6 months to 30 years, were enrolled in a multi-center field study. All horses were confirmed EPM-positive based on the results of clinical examinations and laboratory testing, including CSF Western Blot analyses. Horses were administered PROTAZIL® (1.56% diclazuril) Antiprotozoal Pellets at doses of 1, 5, or 10 mg diclazuril/kg body weight as a top-dress on their daily grain ration for 28 days. The horses were then evaluated for clinical changes via a modified Mayhew neurological scale on Day 48 as follows: 0. Normal, neurological deficits not detected. 1. Neurological deficits may be detectable at normal gaits; signs exacerbated with manipulative procedures (e.g., backing, turning in tight circles, walking with head elevation, truncal swaying, etc.). 2. Neurological deficit obvious at normal gaits or posture; signs exacerbated with manipulative procedures. 3. Neurological deficit very prominent at normal gaits: horses give the impression they may fall (but do not) and buckle or fall with manipulative procedures. 4. Neurological deficit is profound at normal gait: horse frequently stumbles or trips and may fall at normal gaits or when manipulative procedures were utilized. 5. Horse is recumbent, unable to rise. Each horse’s response to treatment was compared to its pre-treatment values. Successful response to treatment was defined as clinical improvement of at least one grade by Day 48 ± conversion of CSF to Western Blot-negative status for S. neurona or achievement of Western Blot-negative CSF status without improvement of 1 ataxia grade. Forty-two horses were initially evaluated for effectiveness and 214 horses were evaluated for safety. Clinical condition was evaluated by the clinical investigator’s subjective scoring and then corroborated by evaluation of the neurological examination videotapes by a masked panel of three equine veterinarians. Although 42 horses were evaluated for clinical effectiveness, corroboration of clinical effectiveness via videotape evaluation was not possible for one horse due to missing neurologic examination videotapes. Therefore, this horse was not included in the success rate calculation. Based on the numbers of horses that seroconverted to negative Western Blot status, and the numbers of horses classified as successes by the clinical investigators, 28 of 42 horses (67%) at 1 mg/kg were considered successes. With regard to independent expert masked videotape assessments, 10 of 24 horses (42%) at 1 mg/kg were considered successes. There was no clinical difference in effectiveness among the 1, 5, and 10 mg/kg treatment group results. Adverse events were reported for two of the 214 horses evaluated for safety. In the first case, a horse was enrolled showing severe neurologic signs. Within 24 hours of dosing, the horse was recumbent, biting, and exhibiting signs of dementia. The horse died, and no cause of death was determined. In the second case, the horse began walking stiffly approximately 13 days after the start of dosing. The referring veterinarian reported that the horse had been fed grass clippings and possibly had laminitis. ANIMAL SAFETY PROTAZIL® (1.56% diclazuril) Antiprotozoal Pellets were administered to 30 horses (15 males and 15 females, ranging from 5 to 9 months of age) in a target animal safety study. Five groups of 6 horses each (3 males and 3 females) received 0, 5 (5X), 15 (15X), 25 (25X) or 50 (50X) mg diclazuril/kg (2.27mg/lb) body weight/day for 42 consecutive days as a top-dress on the grain ration of the horse. The variables measured during the study included: clinical and physical observations, body weights, food and water consumption, hematology, serum chemistry, urinalysis, fecal analysis, necropsy, organ weights, gross and histopathologic examinations. The safety of diclazuril top-dress administered to horses at 1 mg/kg once daily cannot be determined based solely on this study because of the lack of an adequate control group (control horses tested positive for the test drug in plasma and CSF). However, possible findings associated with the drug were limited to elevations in BUN, creatinine, and SDH and less than anticipated weight gain. Definitive test article-related effects were decreased grain/top-dress consumption in horses in the 50 mg/kg group. In a second target animal safety study, PROTAZIL® (1.56% diclazuril) Antiprotozoal Pellets were administered to 24 horses (12 males and 12 females, ranging from 2 to 8 years of age). Three groups of 4 horses/sex/group received 0, 1, or 5 mg diclazuril/kg body weight/day for 42 days as a top-dress on the grain ration of the horse. The variables measured during the study included physical examinations, body weights, food and water consumption, hematology, and serum chemistry. There were no test article-related findings seen during the study. STORAGE INFORMATION Store between 15°C to 30°C (59°F to 86°F). HOW SUPPLIED PROTAZIL® (1.56 % diclazuril) Antiprotozoal Pellets are supplied in 2-lb (0.9 kg) and 10-lb (4.5 kg) buckets. REFERENCES 1. Lindsay, D. S., and Dubey, J. P. 2000. Determination of the activity of diclazuril against Sarcocystis neurona and Sarcocystis falcatula in cell cultures. J. Parasitology, 86(1):164–166. 2. Dirikolu, L., Lehner, F., Nattrass, C., Bentz, B. G., Woods, W. E., Carter, W. E., Karpiesiuk, W. G., Jacobs, J., Boyles, J., Harkins, J. D., Granstrom, D. E. and Tobin, T. 1999. Diclazuril in the horse: Its identification and detection and preliminary pharmacokinetics. J. Vet. Pharmacol. Therap. 22:374–379. May 2010 Intervet Inc. 56 Livingston Ave, Roseland, New Jersey 07068 © 2010 Intervet Inc. All rights reserved. 08-10 211.x.3.1.0
Horse undergoing underwater treadmill exercise during rehabilitation of a tendon injury. Courtesy of Dr. Steve Adair at the University of Tennessee, College of Veterinary Medicine, Equine Performance and Rehabilitation Center https://equinerehab.utk.edu
shown to aid in bone healing as well.
Therapeutic ultrasonography, shockwave therapy and whole-body vibration are mechanical agents. Therapeutic ultrasonography allows for deeper heating without excessively heating the skin. It has been shown to decrease pain and muscle spasm, promote wound healing, reduce swelling and reduce scar tissue. “I primarily use it for fibrous tissues,” Dr. Adair said, “things such as joint capsules, tendons and ligaments.” Whole-body vibration is mainly used to
Dr. Adair stated that he uses obstacles fairly often in practice. “I’ll set different heights of poles,” he explained. “I’ll arrange them so they are increasing or decreasing. As you watch the horse walk through the obstacles, you can see that as the pole height increases, so does the joint motion.” Underwater treadmills are also a popular therapeutic exercise modality. “I will usually have between three to five horses a day going through the treadmill,” he said. “It is low impact, and helps strengthen the horse. One caveat for the treadmill is that they do a great job at getting a horse to be fit, to the extent that they can be a handful when they progress to riding exercise.” Dr. Adair will use heat therapy prior to the treadmill, and he keeps the water around 82° F. Afterward, he will apply cryotherapy. “The height of the water will affect the degree of joint flexion,” he said. “After the water gets to the level of the carpus or the hock, it plateaus and you get no added benefit. I usually just fill it up without targeting joints.” MeV
Therapeutic Monitoring “Therapeutic monitoring is extremely important,” Dr. Adair said. “We perform all of these exercises, but how can we know they are working? We need to keep good records and develop techniques for monitoring.” Progress in clinical improvement, pain levels, range of motion and the need for analgesics should be measured and tracked. Ancillary diagnostic ultrasonography, radiographs and scintigraphy have the potential to monitor the patient’s progress. “It may be as simple as a goniometer and a tape measure,” he explained. “You can get by with a lot of simple things. When I deal with joint issues, quite often I will use the goniometers to monitor therapy. They cost about $10.” 6
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NUTRITION THAT GIVES YOU THE WINNING EDGE
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stem cell products for animals The American Association of Equine Practitioners (AAEP) is encouraging its members to comply with a recent FDA guidance document that outlined regulatory requirements for animal cell-based products (ACPs). ACPs include stem cells and may include plasma-rich protein
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(PRP) and autologous-conditioned serum (ACS, also known as IRAP [interleukin-1 receptor antagonist protein]), which are used to treat joint injuries in horses. â€œA cell-based product, including an animal stem cell-based product, that is intended to diagnose, cure, mitigate, treat or
K a t h l e e n
prevent disease in animals, or is intended to affect the structure or function of the animal, generally meets the definition of a new animal drug,â€? the FDA wrote in its final Guidance for Industry document. As a new animal drug, an ACP must meet the regulatory require-
O g l e
ain Because managing OA p . in a p re o m e s u a c ’t n ld u o sh ty profile.
with an EQUIOXX delivers efficacy
arthritis pain and ht choice for treating osteo rig the is XX UIO EQ d fin l u’l yo When you do the research, . inflammation for your clients for horses – spares COX-1
NSAID XX – the first and only coxib • First and Only – EQUIO 1 ylbutazone, including while inhibiting COX-2 * 2 or more effective than phen ive ect eff as ed rat s wa XX dy, EQUIO rall improvement scores ove and e enc fer cum • More Effective – In a stu cir t , join nipulation, range of motion ;3,4 improvement in pain on ma studies than any other NSAID ety saf in ses hor re mo on n tested • Safety – EQUIOXX has bee ects most horses had no side eff e, dos ed at the recommend also aid in compliance n up to 24 hours which can pai ls tro con e dos e On – t • Convenien been determined. *Clinical relevance has not
D out to pasture. See how Time to put your old NSAI nce for your clients. re ffe di a e ak m n ca X OX EQUI
Available in three formulations to fit in and out of competition needs: Injection, Paste and Tablet. IMPORTANT SAFETY INFORMATION: As with any prescription medication, prior to use, a veterinarian should perform a physical examination and review the horse’s medical history. A veterinarian should advise horse owners to observe for signs of potential drug toxicity. As a class, nonsteroidal anti-inflammatory drugs may be associated with gastrointestinal, hepatic and renal toxicity. Use with other NSAIDs, corticosteroids or nephrotoxic medication should be avoided. EQUIOXX has not been tested in horses less than 1 year of age or in breeding horses, or pregnant or lactating mares. For additional information, please refer to the prescribing information or visit www.equioxx.com. Data on file at Merial, Safety Study, PR&D 0144901. Doucet MY, Bertone AL, et al. Comparison of efficacy and safety of paste formulations of firocoxib and phenylbutazone in horses with naturally occurring osteoarthritis. J Am Vet Med Assoc. 2008;232(1):91-97. 3 EQUIOXX product labels and FOI summaries and supplements. 4 Data on file at Merial, Clinical Experience Report PHN 471, PR&D 0030701. ModernEquineVet.com | Issue 2/2017 1
Merial is now part of Boehringer Ingelheim. ®EQUIOXX is a registered trademark of Merial. ©2017 Merial, Inc., Duluth, GA. All rights reserved. EQUIEQX1607 (1/17)
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. EQUIOXX® (firocoxib) is indicated for the control of pain and inflammation associated with osteoarthritis in horses. Firocoxib belongs to the coxib class of non-narcotic, nonsteroidal anti-inflammatory drugs (NSAID). CONTRAINDICATIONS: Horses with hypersensitivity to firocoxib should not receive EQUIOXX. WARNINGS: EQUIOXX is for use in horses only. Do not use in horses intended for human consumption. Do not use in humans. Store EQUIOXX Tablets out of the reach of dogs, children, and other pets in a secured location in order to prevent accidental ingestion or overdose. Consult a physician in case of accidental human exposure. Horses should undergo a thorough history and physical examination before initiation of NSAID therapy. Appropriate laboratory tests should be conducted to establish hematological and serum biochemical baseline data before and periodically during administration of any NSAID. NSAIDs may inhibit the prostaglandins that maintain normal homeostatic function. Such anti-prostaglandin effects may result in clinically significant disease in patients with underlying or pre-existing disease that has not been previously diagnosed.
ments for current good manufacturing practices and labeling. To be legally marketed, a new animal drug requires an approved or conditionally approved new animal drug application (NADA).
Burden on Equine Industry
Christopher E. Kawcak, DVM, PhD, ACVS, ACVSMR, of the Equine Orthopaedic Research Center at Colorado State University, discussed the FDA’s decision to regulate stem cellbased products for animals at the seventh annual meeting of the Northeast Association of Equine Practitioners in Niagra Falls, N.Y. “There is considerable concern about the impact on the equine veterinary industry,” Dr. Kawcak said. “If you want to
Autologous Animal Cell-based Products (ASCPs) Type I: Autologous products that meet any of the following criteria: • Processed or “more than minimally manipulated” • Cell expansion • Cell differentiation • Addition of purified trophic factors • Non-homologous applications • For example, adipose tissue used in treatment of tendon disease would be non-homologous use. • For use in a food-producing animal • The ASCP’s effect depends on the metabolic activity of its living cells. • T he manufacture of the ASCP involves the combination of the cells with another article, except for water, crystalloids, or a sterilizing, preserving or storage agent unless the addition of the agent raises new safety concerns with respect to the product. • The finished ASCP is combined with or modified by the addition of a component that is another drug or device.
Treatment with EQUIOXX should be terminated if signs such as inappetance, colic, abnormal feces, or lethargy are observed. As a class, cyclooxygenase inhibitory NSAIDs may be associated with gastrointestinal, renal, and hepatic toxicity. Sensitivity to drug-associated adverse events varies with the individual patient. Horses that have experienced adverse reactions from one NSAID may experience adverse reactions from another NSAID. Patients at greatest risk for adverse events are those that are dehydrated, on diuretic therapy, or those with existing renal, cardiovascular, and/ or hepatic dysfunction. The majority of patients with drug-related adverse reactions recover when the signs are recognized, drug administration is stopped, and veterinary care is initiated. Concurrent administration of potentially nephrotoxic drugs should be carefully approached or avoided. Since many NSAIDs possess the potential to produce gastrointestinal ulcerations and/or gastrointestinal perforation, concomitant use of EQUIOXX with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided. The concomitant use of protein bound drugs with EQUIOXX has not been studied in horses. The influence of concomitant drugs that may inhibit the metabolism of EQUIOXX has not been evaluated. Drug compatibility should be monitored in patients requiring adjunctive therapy.
Type II: Autologous products that meet all of the following criteria: • Minimally manipulated • Homologous use (cell function is the same in the donor tissue as in the recipient tissue) • For use in a non-food producing animal • The manufacturing process does not involve the combination of the cells with another article, except for water, crystalloids. The sterilizing, preserving or storage agent does not raise new safety concerns with respect to the product. • The finished ACP is not combined with or modified by the addition of a drug or device. Source: FDA. “Guidance for Industry. Cell-Based Products for Animal Use, #218.”
The safe use of EQUIOXX in horses less than one year of age, horses used for breeding, or in pregnant or lactating mares has not been evaluated. Consider appropriate washout times when switching from one NSAID to another NSAID or corticosteroid. The Safety Data Sheet (SDS) contains more detailed occupational safety information. For technical assistance, to request an SDS, or to report suspected adverse events call 1-877-217-3543. For additional information about adverse event reporting for animal drugs, contact FDA at 1-888-FDA-VETS, or http://www.fda.gov/AnimalVeterinary. Rev 10/2016
produce these, and market and sell them, and charge for them, you need a new [animal] drug application to do that. It can cost several million dollars, and you have to prove safety and efficacy, which is not always easy to do,” he said. Sponsors are required to report adverse events, all labeling and promotion must be truthful and include relevant hazards and precautions. Sponsors must also submit drug experience reports, all safety and efficacy information and all data from all studies. Noting that there are several companies producing fat-, bone marrowand fetal-derived stem cells for use in animals, Dr. Kawcak pointed out, “Few have the financial capacity to justify a true, large FDA study.”
Issue 2/2017 | ModernEquineVet.com
Categories of ACPs include xenogeneic, allogeneic and autologous animal stem cell products (ASCPs). The FDA divides autologous ASCPs into Type I and Type II products (see Table), and it has stated that it has placed a low priority of oversight for Type II products. However, only a small number of products will meet the Type II criteria. For example, although some ASCPs—such as some blood products that are injected into a joint as an anti-inflammatory— are “minimally manipulated,” their use may be regarded as “non-homologous in the sense that it is used to replicate or benefit a tissue,” Dr. Kawcak said. Such a product would be categorized as Type I. “It becomes very difficult right now at this time to make recommendations on how to use these,” he said. According to the FDA, “homologous use” means repair, reconstruction, replacement or supplementation of a recipient’s cells or tissues with a cell-based product that performs the same basic function or functions in the recipient as in the donor (for example, cartilage-derived cells intended to replace damaged cartilage in the recipient). A product that doesn’t meet that definition is considered
Courtesy of Dr. Christopher Kawcak
Type 1 and Type 2 Products
A bone cyst injected with biologic therapy to enhance healing.
to be for non-homologous use. Dr. Kawcak advised equine veterinarians to review the AAEP’s guidance for veterinarians on cell-based products for animal use. The AAEP, which convened a task force in the summer to review the information and provide a synopsis for its members, is encouraging its members to comply with the FDA’s guidelines when using animal cell-based products. “The liability could come onto the veterinarian,” Dr. Kawcak said. “You can’t market an unapproved drug.
ACPs can be used in investigational new animal drug studies but cannot be marketed or sold until they are approved as a new animal drug. “It’s something all of us are going to have to seriously consider— how we use it,” Dr. Kawcak said, adding, “Many of us would agree that in some cases, stem cells have MeV been hugely beneficial.” For more information, visit: www.fda.gov/AnimalVeterinary/ NewsEcents/CVMUpdates/ ucm450556.htm.
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ModernEquineVet.com | Issue 2/2017
Courtesy of Penn Vet
Tips for Improving Survival in the Colicky Horse Through the creation of a standard approach, the use of faster interventions and an increased breadth of surgical experience, survival rates in colicky horses have greatly improved. “We’re sitting in a different spot than we were 15 years ago,” said Barbara Dallap Schaer, VMD, DACVS, DACVECC, medical director of Penn Vet’s New Bolton Center in Kennett Square, Pa. “There are many procedures that are quite successful now that weren’t in the past, and we B y 12
Issue 2/2017 | ModernEquineVet.com
have a different level of postoperative support in these patients.” Dr. Dallap Schaer recently presented some practical tips for rectal examination and ultrasonography at the 62nd Annual AAEP Convention in Orlando.
Finding Your Findings
“At surgical facilities, we have the benefit of correlating our rectal findings, often after we open up the horse,” Dr. Dallap Schaer explained. “That helps us to link
P a u l
these findings together, but it’s not something that can often be done in the field.” She explained that if a veterinarian has a high index of suspicion for a particular lesion, then that may inform what is felt on palpation. “When you perform abdominal palpation per rectum, it sometimes helps to visualize in your mind’s eye what you’re looking for.” Dr. Dallap Schaer said that one of the most misdiagnosed lesions on rectal examination is nephro-
B a s i l i o
splenic entrapment. Many veterinarians will describe what they think they feel when a horse has the condition, but actually identifying the lesion is harder than some may realize. “The most salient feature on rectal palpation of a nephrosplenic entrapment is a large gasdistended colon,” she said. “It feels like someone has hung it from the dorsal body wall. As you trace the distended colon, it goes left and dorsal until you almost can’t fit your hand between the dorsal body wall and the distended colon. As you feel axially toward the kidney, you can feel the kidney right there. In a true nephrosplenic entrapment, that’s fairly characteristic. You likely won’t be able to feel the spleen, and if you can, it will be displaced far ventrally.”
Many providers will describe what they think they feel when a horse has nephrosplenic entrapment, but identifying the lesion is harder than some may realize.
Dr. Dallap Schaer and her colleagues recently performed a prospective clinical trial involving a modified fast localized abdominal sonographic evaluation of the horse (mFLASH) in combination with abdominal palpation per rectum. The team used five sonographic “windows” to try to focus on whether lesions could be correlated. The first window is located on the ventral abdomen. “This location is useful when looking for distention of the small intestine,” Dr. Dallap Schaer said. “It’s the most likely area where you are going to see a thickened area of small bowel. Try to look for the sweet spot, which is up in the inguinal region.” The second window—sometimes called the “gastric window”—
ModernEquineVet.com | Issue 2/2017
Courtesy of Penn Vet
Checking a horse after surgery.
is located further up the thorax. “In this space you’re looking for gastric distention that might indicate a small intestinal obstruction,” she explained. “I’ll often trace how distended the stomach is over several intercostal spaces. You might even find some distended small intestine in this window.” The third window is found on
the left side of the horse, heading up to the nephrosplenic space or the flank area. This is prime territory for investigating nephrosplenic entrapment. “If you have been palpating this area after you perform a rectal examination, you may find a gas-filled small colon,” Dr. Dallap Schaer said. “This might give the false ap-
pearance that you have found a distended, gas-filled viscus sitting on or near the spleen. To confirm this diagnosis, try to follow that distended colon cranially for several intercostal spaces so you can convince yourself that the distended colon goes beyond this little window. It sits dorsal to the spleen as it distends cranially in the abdomen.” The fourth and fifth windows are on the right side of the horse. Often, looking through the duodenal window can be helpful if the duodenum is markedly distended and cannot contract. This would indicate that there is some distention of the small intestine somewhere in the abdomen. “One of the things we think about is whether you can see distended vasculature related to the mesocolon,” Dr. Dallap Schaer said. “If you see that running the whole way down the length of the right body wall in window 4 and 5, then you can be pretty confident that you’ve got a right dorsal displacement. In no way should the mesocolon be alongside the body wall on the right side of the horse.” MeV
When to Refer? Dr. Dallap Schaer explained that early referral is likely the most significant development that has improved survival. “In the early 1980s, [likelihood of] survival was less than a coin toss,” she said. “Since then, most institutions that perform colic surgery have about an 80% or 90% survival rate. That’s an important thing to explain to clients. The survival for surgical colic has changed dramatically.” When making the decision, the most salient factors have to do with how sick the horse is and the type of physiologic decline. “If you have a patient who looks toxic and injected, has a high heart rate and high respiratory rate, then you certainly need to start thinking about referral,” Dr. Dallap Schaer said. “A horse can be difficult to manage on the farm if something is causing significant endotoxin absorption. In addition, if you need large volumes of fluid with persistent reflux—that is going to be difficult to keep up with in a farm setting.” If an abnormality that is associated with a surgical lesion is noted on abdominal palpation via the rectum—such as thickening of the small intestine—an intussusception or a markedly abnormal positioning of the large colon, then referral also is likely, she said.
Issue 2/2017 | ModernEquineVet.com
FDA Ban on Powdered Medical Gloves Applies to Veterinary Use Late last year, the FDA’s Center for Devices and Radiological Health issued a final rule banning all powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating surgical gloves intended for use by humans because these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by a change in labeling. The ban applies to all powdered medical gloves used by humans except powdered radiographic protection gloves, including powdered medical gloves used in the practice of veterinary medicine, according to the Center for Veterinary Medicine. This ban became effective Jan. 18, 2017 for any devices intended for use by humans that are in commercial distribution and for any devices already sold
to the ultimate user. This means that powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating surgical gloves that have already been sold to or are already in the possession of end users—including veterinary clinics and animal surgical centers—are subject to the ban. The FDA advises stakeholders and institutions to dispose of pre-existing supplies of powdered medical gloves in accordance with standard industry practices and established procedures of the local community’s solid waste management system. Non-powdered alternatives for surgeon’s and patient examination gloves are available and offer the same level of protection, dexterity and performance as powdered gloves without carrying the risks associated with powdered gloves. MeV
Significant Remodeling Seen in Aortic Rupture in Friesans Friesans may have a breed-related defect that increases their risk of aortic rupture. Researchers recently found significant remodeling at the site of aortic rupture in Friesans, which are not present at other sites in the body or in unaffected Friesans. Researchers conducted a post-mortem study aimed to determine whether there is a breed-related defect in the extracellular matrix (ECM) in Friesans, which predisposes them to aortic rupture. Tissue from 18 affected Friesans, 10 unaffected Friesans and 30 Warmblood horses (in which aortic rupture is uncommon) was analyzed. ECM components (amino acids concentrations, collagen cross-linking, metalloproteinase activity and glycosaminoglycan content) were measured in the aortic wall and the deep digital flexor tendon (DDFT). There was no difference in total collagen content among the three groups. At the aortic rupture site in affected Friesans collagen hydroxylation, MMP activity, elastin and collagen cross-linking were significantly higher than at the same site in unaffected horses. There were no differences in the aorta ECM between Warmbloods and unaffected Friesans. Collagen lysine hydroxylation was significantly lower in the DDFT of unaffected Friesans compared
with Warmbloods suggesting differences in collagen metabolism between the two breeds. There was no difference at the DDFT site between affected and unaffected Friesans, with differences only seen at the aortic rup-
ture site, suggesting the absence of a generalized ECM disorder in the breed. Potential differences in collagen metabolism between Friesans and other breeds warrant further investigation, the researchers said. MeV
Ploeg M, Gröne A, van de Lest CHA, et al. Differences in extracellular matrix proteins between Friesan horses with aortic rupture, unaffected Friesans and Warmblood horses. Equine Vet J 2017 Jan. 12 [Epub ahead of print]). http://onlinelibrary.wiley.com/doi/10.1111/evj.12654/full
For more information:
ModernEquineVet.com | Issue 2/2017
Managing Significant Trauma in a Senior Paint Gelding By Tammy Treitline LVT, VTS-EVN On June 28, 2011 a 15-year-old blind paint gelding presented to our veterinary clinic. The clients were concerned about his breathing because they thought his breathing rate and effort were increased. They also noticed nasal discharge and raspy noises. Along with the breathing issues, the client noticed increased swelling on the left mandible area, where an injury had occurred two days prior. The injury the gelding suffered was from trauma caused by a sucker rod that penetrated through the oral cavity and the left mandible. The gelding was treated the night of the injury. The wound caused by the sucker rod was flushed, debrided and sutured by the attending veterinarian. He
Courtesy of Tammy Treitline LVT, VTS-EVN
Figure 2 Figures 1 and 2: Digital radiographs showed a fracture of the left mandible, with a fracture line extending dorsal and caudal toward the condylar process
Issue 1/2017 | ModernEquineVet.com
was also given a tetanus toxoid booster intramuscularly, IM procaine penicillin G and the anti-inflammatory, IV flunixin meglumine. When the gelding was seen on June 28, he was showing signs of dyspnea, with increased inspiratory effort. Auscultation of the lungs was normal. The capillary refill time was less than 2 seconds, and the mucous membrane color was slightly murky and a little tacky. Rectal temperature was 99.9Â° F. The gelding was sedated with IV xylazine hydrochloride for an oral examination, which revealed displacement of the upper arcade and the left mandible had more mobility than normal. Ultrasonography of the left side of the head, around the mandible area, where the swelling and crepitation were palpated showed a large pocket of hypoechoic fluid with gas tracks present. Digital radiographs showed a fracture of the left mandible, with a fracture line extending dorsal and caudal toward the condylar process (Figures 1 and 2). There was a significant amount of subcutaneous edema present in the surrounding tissues. Endoscopic evaluation of the upper airways was performed and showed feed present in the nasal passage and trachea. There was dorsal displacement of the soft palate over the epiglottis. Also interfering with the airway was dorsal compression and collapse of the pharynx and proximal trachea, caused by all the surrounding soft tissue edema and swelling. The arytenoid cartilages showed no movement. These findings suggested nerve damage caused by the initial injury from the sucker rod that occurred two days prior. With the findings on physical exam, oral exam, ultrasound, digital radiographs and endoscopy, the client decided to continue with treatment, and to see how the gelding responded over the next few days. Treatment was continued by placement of an emergency temporary tracheostomy, performed to improve airway restrictions. Blood was also taken for packed cell volume (PCV) and total protein. The PCV was 50% and total protein was 9 mg/dL, both of which were elevated and which would indicate dehydration with concurrent infection or inflammation. For the emergency temporary tracheostomy, an area approximately one-third of the distance down the neck and ventral from the throat latch was clipped and prepared in standard surgical fashion. A local nerve block with lidocaine hydrochloride was applied subcutaneously. Then an incision was made along the ventral aspect of the trachea between the tracheal rings. The incision separated the connective tissue and mucosa between tracheal rings allowing an opening
AAEV T M E M b E r s h i p Membership in the AAEVT is open to all veterinary technicians, assistants, support staff and those employed in the veterinary health care industry worldwide. Student membership is open to those currently enrolled in an AVMA/CVMA accredited veterinary technology program.
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AAEVT Objectives • • • •
Provide opportunities for CE, training, communication, and networking Educate the equine veterinary community and the public about our profession Inform Members of issues affecting our profession Assist in providing the best medical care to improve the health and welfare of the horse
AAEVT Online Equine Certification Program
• A three course, 10 module, equine-only online program offered through ACT • Geared toward Credentialed Veterinary Technicians, Assistants, Support staff, & Students • Areas of study include: equine medical terminology, anatomy and physiology, parasitology, laboratory, diagnostics, equine basics (breeds, wellness, husbandry,) diagnostic procedures, emergency medicine, restraint, pharmacology, surgical assistance and anesthesia, equine office procedures • A certificate of completion is awarded to those who: Successfully complete required courses Complete the list of required skills (per a supervising DVM who is an AAEP member) Attend an AAEVT regional CE symposium and participate in the we labs • Those individuals who successfully complete the programs will be recognized as AAEVT Certified Equine Veterinary Technicians / AAEVT Certified Equine Veterinary Assistants depending on their current designation. The certificate is recognized by the AAEVT and the AAEP but does not grant the credentialed status by the AVMA • For more information go to www.aaevt.4act.com or call 800-357-3182
AAEVT Mission Statement: To promote the health and welfare of the horse through the education and professional enrichment of the equine veterinary technician and assistant.
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straight into the trachea. This allowed placement of the tracheostomy tube. The temporary tracheostomy tube was cleaned with Virosan and checked daily, to make sure proper placement was still achieved. The tracheostomy tube was left in place for six days of hospitalization, then removed due to his continued improvement. Additionally, he exhibited good air movement thorough his nostrils. He did show a slight deviation to the right side with his muzzle due to facial nerve damage that occurred. The left jugular vein was properly prepared for placement of a extended use over-the-needle IV catheter. Fif-
Courtesy of Tammy Treitline LVT, VTS-EVN
Figure 5 Figure 3: The tissue became necrotic and started to slough, leaving an open wound. Figures 4 and 5: At the 15-day recheck the wound had granulated in approximately 35 to 40%. Figures 6 and 7: On the 18 day recheck, the wound had completely granulated in and looked great.
Issue 2/2017 | ModernEquineVet.com
teen liters of lactated Ringerâ€™s solution were given as a bolus. The rate then was reduced to approximately 2 L/hour overnight. Along with the lactated Ringerâ€™s solution, he was given IM procaine penicillin G every 12 hours, IV gentamicin every 24 hours, and IV flunixin every 12 hours. The gelding was maintained on IV fluid therapy for the next four days. The injectable antibiotics and anti-inflammatory medication were continued for the next five days, after which he was placed on oral medications. A complete blood count (CBC), serum chemistry and electrolytes were performed on the third day of hos-
Figure 8: The digital radiographs reveal calcification of the left mandible.
Courtesy of Tammy Treitline LVT, VTS-EVN
pitalization. The automated CBC revealed the PCV of 45%, which was improved from initial values and within normal limits. The white blood count (WBC) was 4.68 K/µL, which was below normal limits. Of the WBCs, the neutrophils were slightly below normal at 1.96 K/ µL or 41.9%. The electrolyte results showed sodium at 135 mmol/L and potassium at 3.1 mmol/L, which were lower-normal levels. The chloride was at 103 mmol/L which is within normal levels. The serum chemistry results showed total protein at 8 g/dL, globulins at 5.3 g/dL, AST at 933 U/L and LDH at 2,800 U/L, which were all elevated. The CK levels registered out of normal reference range. No dilution of CK levels were performed. The serum chemistries could be a result of the muscle trauma, infection and inflammation resulting from the injury and healing process. The gelding continued on IV lactated Ringer’s solution, but potassium chloride, 23% calcium gluconate, and 50% dextrose were added to support the electrolyte levels. Another endoscopy was also performed to see if there was any improvement. It revealed some slight movement of the arytenoid cartliages along with a decrease in inflammation of the soft palate, which allowed more visualization of the epiglottis. There also was less dorsal compression and collapse of the proximal pharynx and trachea. This was more encouraging for his prognosis for survival. Hydrotherapy was performed on the left side of face. At this time the tissue had started to become necrotic and slough, leaving an open wound. Pieces of tissue and bone fragments of the mandible were removed daily. The open wound was cleaned and dressed with silver sulfadiazine twice a day, to prompt a good bed of granulation tissue to form. It also helped to keep tissues moist and to help topically the infection. The gelding was exhibiting a very good attitude, behavior and seemed comfortable tolerating the debridement and cleaning. On the fourth day of hospitalization the gelding was reduced to 1 L/hr of lactated Ringer’s solution, which was removed later that evening. He was offered water and a slurry of senior feed, which he was able to eat very well considering the extent of injury of the mandible. He was continued on senior feed and worked up to 4 lbs of feed three to four times a day to try to maintain his body condition. The gelding was also switched to oral doxycycline twice a day, for two weeks. Oral phenylbutazone powder was administered for seven days, then reduced to once a day for seven more days. The fracture was left to calcify at this time, due to the open wound contamination, the number of bone fragments, and the amount of tissue necrosis. This type of wound has the potential for formation of sequestrums. Other concerns for the gelding from this injury are
chronic nerve damage, chronic sinusitis, naso-oral fistula formation and non-union of the mandible fracture. The gelding was doing very well with the daily cleaning of the wound. He was eating all of the senior food at each feeding and drinking water. Urination and fecals were normal. Physical exams were within normal limits. His temperature remained normal. His attitude, behavior and comfort level seem to be within normal limits. The gelding was released from the hospital 17 days after the initial visit. When he was released, the open wound had good granulation tissue and had started contracting in on the sides. There was still bone exposure of the mandible where the fracture could be palpated. The client was instructed to continue with daily to twice-aday cleaning with Virosan and topical application of silver sulfadiazine cream to keep the granulation tissue moist and clean. A recheck in 15 days was also scheduled. At the 15-day recheck the wound had granulated in at approximately 35% to 40%. Bone of the mandible was still exposed a little, but continue to heal. The client was doing a great job on keeping the wound clean and moist. Another recheck was made in 18 more days, where digital radiographs were taken. They looked good, too. MeV
About the author
Tammy Treitline, LVT, VTS-EVN, has been a veterinary technician for more than 15 years and currently works at Casselton Veterinary Services in Casselton, N.D. She enjoys spending time with family, friends and horses. ModernEquineVet.com | Issue 2/2017
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