The differences between pioneer products, generics, medical devices and compounded products.

There are some important facts to consider when choosing a joint health option. Get the facts at nogenericadequan.com.

From AQHA Corporate Partner Adequan

When a horse or companion animal becomes sick or lame, you turn to your veterinarian for a diagnosis and the best, proven treatment to make your animal better.

But, just because a product is available for purchase doesn’t make it a proven product or the right product to treat the problem. So, do you treat with an FDA-approved innovator drug, an FDA-approved generic drug, a medical device or a compounded product?

In considering this question, Dr. Jeffrey Berk, a veterinarian at Equine Medical Associates in Lexington, Kentucky, says horse owners need to consider two things very carefully.

“When considering an alternative treatment, veterinarians and horse owners need to understand they are not guaranteed the same level of safety or quality — i.e. potency and purity — as you would with an FDA-approved product,” says Dr. Berk, who is a member of the executive committee of the American Association of Equine Practitioners.

FDA-approved products

Some experts estimate that it takes four to six years and millions of dollars to get an FDA-approved animal drug from the laboratory to the marketplace. Most of the money is spent on conducting studies that prove the drug’s effectiveness in a form acceptable to the Food and Drug Administration, the governing body over both human and animal drug approval. The FDA approval process is the most extensive law of its kind in any country. All regulations are focused on protecting the end user and providing a safe, effective product. In short, the FDA will not allow a company to market a drug as FDA-approved if it has not proven its effectiveness in multiple scientific studies.

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The FDA reviews marketing claims and labeling for approved drugs, so the consumer has a clear understanding of what to expect. Check the medication administered to your horse. If it’s FDA-approved, it will have a package insert that explains specifically where the drug should be administered, what the dosage should be for a specific species and what condition or disease the drug is supposed to treat.

FDA approval doesn’t end when the product is released to the market. Companies granted FDA approval for their drugs must continually demonstrate consistency, efficacy and good manufacturing processes, which includes plant inspections conducted by the FDA. Also, it’s mandatory for manufacturers of FDA-approved products to record and notify the FDA of any adverse reactions to their drug.

The price for an innovator drug can be high, and you may want to find a cheaper treatment, but Dr. Berk says it’s usually a lack of understanding that prompts this response.

“If you discuss the options with your veterinarian, and he recommends an FDA-approved drug instead of a device or compounded product, you should really consider his recommendation,” says Dr. Berk, who has practiced in Ohio, Florida and Kentucky. “I tell my clients, ‘Yes, you could use these products, but there are legal and liability issues involved, and you are not as likely to get a good outcome.’ When I discuss all the reasons for FDA-approved vs. medical devices and compounded products, very few clients want to use those other products.”

Generic drugs

According to the FDA, a generic drug is bioequivalent to the innovator drug and is also FDA-approved. The approval process is easier and faster for a generic drug than an innovator drug because the manufacturer doesn’t have to conduct preclinical or clinical studies. However, the manufacturer must scientifically prove the generic drug performs in the same manner as the innovator drug.

After a generic drug is approved, the manufacturer also must comply with the same regulations as the pioneer drug. The marketing and labeling must be reviewed and approved so it doesn’t mislead the public. Even generic products will have a product insert in every box.

Not every innovator drug has a generic brand available to the market. For example, Adequan i.m. (Polysulfated Glycosaminoglycan) has no generic equivalent. Because generic drugs are FDA-approved, it is illegal to call a product the generic form of another drug when it has not been FDA-approved as such. Get the facts at nogenericadequan.com.

Medical devices

“The medical devices have slipped through the cracks because there is no stringent approval process for them as long as they are used as medical devices,” says Dr. Berk. “Polyglycan is the classic example. Here is a medical device that is being used as a drug. What it’s supposed to be used for is a post-operative joint lavage. Nobody is using it that way. Everybody is using it systemically as a substitute for Adequan i.m. (Polysulfated Glycosaminoglycan) and/or Legend (Hyaluronate Sodium), which are FDA-approved drugs.”

According to the FDA, a medical device is an instrument, machine or implement that can be used to diagnose, cure or prevent a disease, which does not achieve its intended action through chemical reaction or by being metabolized by the body. Simply stated, a device is not intended to change chemically or be absorbed by the body to achieve its purpose. Syringes, lavages, prosthetics and shock-wave units are examples of medical devices.

A veterinary medical device is not approved or registered by the FDA. There are no premarket notification, premarket approval or mandatory adverse event reporting requirements. The FDA only oversees the misbranding, mislabeling and adulteration of veterinary medical devices. A medical device cannot be marketed as a drug or claim to work like one.

Compounded products

Compounded products are available to veterinarians to treat a unique disease or address a unique situation. The FDA’s position is that it is illegal to compound in bulk and sell to third parties. Compounding is reserved for when there isn’t a commercially available drug that can properly treat a specific affliction.

“The problem we are seeing with compounded products is the compounding pharmacies are expanding their product lines to compete with FDA-approved products,” says Dr. Berk. “That is wrong and illegal.  There are times when compounding is appropriate and good, and the basic criteria for compounding must always be met, i.e. the compounded product must be made for a specific patient to accommodate a specific need at a specific point in time.”

Download AQHA’s FREE Horse Wound Care report and receive first-aid tips to ensure your horse heals as fast as possible.

Compounded products can vary greatly in their chemical makeup. At the 2010 AAEP convention in Baltimore, Dr. Scott D. Stanley and Dr. Heather DiMaio Knych presented a study on compounded drugs. They studied seven different liquid variations of Pergolide Mesylate, with two bottles of each used in the study. They tested each bottle immediately after receipt and found nine of the 14 bottles were lower than the FDA standard for potency. Even under proper storage, the study found that by Day 15, only three bottles contained an FDA standard equivalence for potency.

When considering a treatment option, it is important to know what the product is proven to do. Is it a drug that is proven to create a desired response, or is it a device that should be used as a final wash before closing up a wound or surgical incision? Is it a generic version of a successful product that is FDA approved, or is it a compounded product for a unique situation? Talk to your veterinarian to ensure that you are informed on the best treatment option for your horse.

Tips on avoiding illegal imposters of brand-name drugs.

From AQHA Corporate Partner Merial

Dr. April Knudson is an equine specialist with Merial Veterinary Services. She has a special interest in sport horse lameness and internal medicine. She holds a doctor of veterinary medicine from the University of California-Davis. Below, she answers a question about compounded equine drugs.

Q. Some of my friends at the barn were talking about compounded drugs and whether or not they are safe to use. What are they? Should I ever use them?

A. I’m glad you asked that question because the equine drug marketplace can be overwhelming. There are websites offering drugs for sale, products being sold at equine events around the country and opinions available from everyone who has ever owned a horse. It’s really important to sort through all of the information and consult with your veterinarian, if needed, before giving anything to your horse.

First, let’s clear up any confusion about what is meant by a “compounded drug.”

The American Association of Equine Practitioners defines a compounded drug as one that is created by manipulating an existing U.S. Food and Drug Administration-approved drug.¹ Examples include crushing a tablet to make a paste or gel or adding a flavor to a drug to make it more palatable.²

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For a drug to be legally compounded:

• It must be compounded by a licensed veterinarian or pharmacist for a single horse to meet a specific need,²
• The horse owner must have a valid client-patient relationship with the prescribing veterinarian,²
• There must be no FDA-approved, commercially available drug that will appropriately treat the patient,¹ and
• The product must be made from an FDA-approved commercially available drug.¹

While the use of legally compounded drugs is recognized as an occasional necessity in equine health care, AAEP cautions veterinarians to “limit the use of compounded drugs to unique needs in specific patients.” Because of the time and financial investment required to bring a new equine drug to the marketplace, there are times when a legally compounded medication could be a veterinarian’s only option.

Unfortunately, some FDA-approved equine drugs are illegally manufactured, then advertised and/or sold to horse owners who are led to believe that they are the same as those legitimately on the market. These drugs have not been through the stringent FDA approval process, so they have not been demonstrated to be safe or effective for their intended use.³ Illegal manufacturers often make claims about how well the drugs work, but are not required to prove them. Consider these claims carefully and, if in doubt, ask the manufacturer for proof that the product works and that the manufacturer can back up its claims.

Currently, there are a number of illegally manufactured drugs being marketed to horse owners as the equivalent of brand name drugs such as Ulcergard (omeprazole), Gastrogard (omeprazole), Adequan (polysulfated glycosaminoglycan), Banamine (flunixin meglumine), Phenylbutazone, Protazil (diclazuril)and Regu-Mate (altrenogest). Horse owners should be especially wary of any product claiming to be the same as or the “generic” version of Ulcergard or Gastrogard. These two brand-name drugs are the only FDA-approved products for the prevention⁴ and treatment⁵ of equine stomach ulcers. There is no generic version of either product.

While compounded drugs have not received FDA approval, rest assured that brand name and even generic drugs have, which helps ensure that the product label claims are truthful and accurate.¹ Before considering any drug for your horse, checking to see whether that drug is FDA-approved should be an important consideration. This can be done by looking for a New Animal Drug Application number, or, for generic animal drugs, an Abbreviated New Animal Drug Application number. The six-digit numbers and the statement “Approved by the FDA” are usually found on the drug’s label. A list of approved drugs can also be found in a database that can be accessed by searching the Internet for “AnimalDrugs@FDA.”

Download your copy of Potomac Horse Fever today and arm yourself with knowledge that will help your horse stay healthy.

Remember, if you have any doubts, consult your veterinarian.

For more information about Ulcergard and Gastrogard, visit www.ulcergard.com and www.gastrogard.com.

Important Safety Information: Caution: Safety of Gastrogard in pregnant or lactating mares has not been determined. Ulcergard can be used in horses that weigh at least 600 pounds. Safety in pregnant mares has not been determined.

Gastrogard and Ulcergard are registered trademarks of Merial Limited. All other trademarks are the property of their respective owners. ©2012 Merial Limited, Duluth, GA. All rights reserved. EQUIUGD1214 (04/12)

¹ American Association of Equine Practitioners. Equine Veterinary Compounding Guidelines. Available at: http://aaep.org/pdfs/drug_compounding_guidelines.pdf. Accessed February 27, 2012.
² Animal Health Institute and American Veterinary Medical Association and American Veterinary Distributors Association. Veterinary Compounding. Available at: http://www.aaep.org/siteadmin/modules/page_editor/images/files/AHI%20Compounding.pdf. Accessed March 21, 2012.
³ Lau, E. Confounding compounding part II. Veterinary Information News Service. Available at: http://news.vin.com?VINNEWs.aspx?articled=14399. Accessed February 28, 2012.
⁴ Ulcergard product label.
⁵ Gastrogard product label.

Help keep this infectious disease from inhibiting your show season.

Many horse owners think their horse is immune to threat of infectious equine diseases, but they may want to think again. Journal photo.

From AQHA Corporate Partner Pfizer Animal Health

“It won’t happen to my horse.”

“The disease hasn’t been in my area.”

“It has affected horses in a different discipline than what I ride.”

Many horse owners think their horse is immune to threat of infectious equine diseases, but they may want to think again.

A year ago, in April 2011, news broke about horses attending an equine event in Ogden, Utah, who were exposed to equine herpesvirus-1. Three months later, the USDA Animal Plant and Health Inspection Service declared the outbreak contained, but by then, more than 2,000 horses had been exposed¹.

Of those, 90 tested positive for the virus or its neurologic form, equine herpesvirus myeloencephalopathy¹. Ultimately, 13 horses died or were euthanized as a result of the disease¹.

Just more than half of the 90 horses actually participated in the Ogden event, demonstrating the highly contagious nature of equine herpesvirus-1 and its ability to spread quickly. The remaining 36 horses contracted the virus due to secondary exposure to those horses who attended the show, such as airborne exposure or contamination of water buckets, tack or grooming equipment. Cases were confirmed in 10 states, stretching from Oklahoma to California¹.

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In January 2012, 17 cases of equine herpesvirus-1 were confirmed in California1. On April 6, the California Department of Food and Agriculture confirmed that a mare from Santa Barbara County, California, tested positive for the non-neurological form of equine herpesvirus-1². In addition, a Los Angeles County mare diagnosed on March 30 with equine herpesvirus-1 was the fourth California horse confirmed positive with the non-neurological strain, which stemmed from the HITS Thermal Horse Show, which took place March 5-11, 2012².

“Equine herpesvirus is highly contagious and can affect a number of horses before horse owners and veterinarians realize there is problem,” says Dr. Tom Lenz, senior director of equine veterinary services for Pfizer Animal Health. “The disease is transmitted through both direct and indirect contact with infected horses and can be spread via water buckets, feed tubs, tack, grooming equipment and even on the hands and feet of people caring for affected animals.”

Equine herpesvirus-1 is most likely to create clinical disease, such as respiratory distress, fever, nasal discharge, cough, anorexia and abortions. Recent outbreaks of equine herpesvirus-1 have also involved an uncommon but devastating secondary disease known as equine herpesvirus myeloencephalopathy, which causes neurologic symptoms such as hind limb ataxia or weakness, decreased tail tone, urinary incontinence and death. The prognosis for recovery in horses that do not go down is favorable, but poor for horses that remain recumbent for more than two days. Equine herpesvirus myeloencephalopathy occurs rarely with equine herpesvirus-4 respiratory infections and can also occur with no previous signs of respiratory disease.

Equine herpesvirus is particularly hard to manage because a horse may become latently infected and not display symptoms for many years after infection. The disease may then be activated by periods of stress caused by training, competition, transportation or other environmental situations.

While there are no vaccines labeled for the prevention of equine herpesvirus myeloencephalopathy, horse owners should discuss equine herpesvirus vaccination protocols with their veterinarian.

Pfizer Animal Health offers the FLUVAC INNOVATOR® EHV-1/4 vaccine to help prevent equine rhinopneumonitis due to equine herpesvirus-1 and equine herpesvirus-4, and equine influenza due to type A2 viruses. In addition, PNEUMABORT K®+1b helps prevent respiratory diseases caused by the equine herpesvirus-1 viruses.

When administered prior to exposure to stressful situations such as horse shows, transportation or exposure to disease, immunomodulators can help stimulate and prepare a horse’s immune system to function more efficiently. ZYLEXIS® from Pfizer Animal Health is a demonstrated safe and effective immunomodulator that stimulates the immune system and helps to reduce upper respiratory disease caused by equine herpesvirus-1 and equine herpesvirus-4. As with all vaccinations, owners should discuss their options with a veterinarian. Immunomodulators should not be used in horses with a fever or showing signs of clinical disease.

The world’s largest single-breed monthly publication, The American Quarter Horse Journal has served the industry as the most valued resource for critical news, timely information and insightful articles for more than 60 years.

While vaccination programs and hygiene management practices may not completely prevent the spread of equine herpesvirus, informed owners can help provide their horses with the best level of protection. Ongoing herd management practices, such as isolating new horses from the main herd, not sharing feed pans or water buckets between horses and thoroughly disinfecting tack and grooming equipment should be part of a facility’s daily routine, especially during proximity to an outbreak.

References

1. Looking Back: 2011 EHV-1 Outbreak. March 31, 2011. Available at: http://www.thehorse.com/ViewArticle.aspx?ID=19804&src=topic. Accessed on April 23, 2012.

2. Larson, Erica. EHV-1: Additional Non-Neurological Case Identified in California. April 10, 2012. Available at: http://www.thehorse.com/ViewArticle.aspx?ID=19860&src=topic. Accessed on April 23, 2012.

Fly season is fast approaching. Keep flies away all summer with these helpful tips from AQHA Corporate Partner Farnam.

Use a fly mask this summer to give your horse protection against pesky flies. Photo courtesy of Farnam.

From AQHA Corporate Partner Farnam

Why Fight Flies?

Fly control keeps your horse comfortable. But that’s not the reason to minimize flies.

Flies and other biting insect pose a major health threat to your horse and you. Flies carry a number of dangerous diseases that become more of a problem as fly populations increase.

Flies live, feed and breed filth, where germs, bacteria and communicable diseases thrive. Good hygiene is critical to keeping flies and other filthy problems under control.

Start With a Strategy

Effective fly control means eliminating flies on all fronts, at all life stages in the fly life cycle. Eliminating immature flies reduces the number of biting, breeding adult flies you have to deal with.

No single fly product will solve your fly-control problem. You need an overall plan to get rid of flies where they live, feed and breed. For maximum effectiveness, attack flies on all fronts: on your horse, in the barn and around outdoor areas.

Help protect your horses against the EHV-1 virus by keeping them healthy. For a guide on common horse health issues, check out the Common Horse Health Issues report to help you better understand diseases and illnesses that horses can be faced with.

Farnam offers Centaura insect repellent for horses and riders.

FAQ: Farnam’s Centaura Spray

Q: What is the active ingredient in Centaura spray?

A: Centaura spray contains 20 percent Picaridin.

Q: What is Picaridin and how does it work?

A: The repellent evaporates from the skin into the air forming a layer that interferes with the insect’s ability to “see” the animal. This layer interferes with the blood-seeking arthropod’s attractant mechanisms. The layer of Picaridin camouflages the attractants emitted by the human and equine host and the arthropod cannot find this host because it cannot smell it.

Q: How is Centaura spray applied?

A: Hold 4-6 inches from body while spraying, keeping nozzle pointed away from face. Slightly moisten skin or hair coat with a slow sweeping motion. Excessive amounts or frequent reapplication are not necessary. Do not spray directly on face. Apply on face by first spraying small amounts in palms of hands and spreading on face and neck, avoiding eyes. Do not apply to the hands of small children.

Q: How many applications will one 15-ounce can of Centaura spray provide?

A: One 15-ounce container of Centaura spray will treat eight to 15 horses/applications. Excessive amounts or frequent reapplication is unnecessary.

Q: How efficacious is Centaura spray, how long does it last?

A: Centaura spray provides long-lasting, 12-hour effective protection from flies, mosquitoes and ticks.

Q: Does Centaura spray kill flies, mosquitoes and ticks or is it only a repellent?

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A: Centaura spray is a repellent only.

Q:Can I use Centaura spray on my horse’s face?

A: Yes, Centaura spray can be applied to areas of the horse’s face and ears but not by spraying. Apply by spraying small amounts in the palms of your hands and spreading on the horse’s ears and face, avoiding the eyes. Do not apply to the hands of small children.

See more FAQs about Centaura spray.

For more information about Farnam products, visit www.farnamhorse.com.

Insight on vaccination decisions and vaccine-manufacturer support.

Provide the best possible disease protection for your horse. Journal photo.

From AQHA Corporate Partner Pfizer Animal Health

As a horse owner, you make important health care decisions for your American Quarter Horses on a daily basis. Everything from what to feed your horse to a training regimen is dependent on your plans for the horse and the horse’s overall condition. Similarly, your veterinarian reviews many factors when administering preventative health care, such as vaccinations, for your horse.

When vaccinating horses, veterinarians consider many factors, such as diseases that may be circulating in a specific region, the potential exposure to new horses and whether the horse will travel to shows and other events where unfamiliar horses are present. Obviously, the top priority for any veterinarian is to help provide the best possible disease protection for each horse, so the efficacy and safety of the vaccines used weigh heavily on a veterinarian’s decision to use specific products.

Learn more about your horse’s health with the Common Horse Health Issues report.

Manufacturer support is demonstrated by the Equine Immunization Support Guarantee from Pfizer Animal Health, which provides up to $5,000 for reasonable diagnostic and treatment costs if a horse properly vaccinated by a veterinarian contracts the corresponding equine disease.

Disease protection backed by the Equine Immunization Support Guarantee includes infection from West Nile virus, equine influenza virus, tetanus, eastern equine encephalomyelitis virus, western equine encephalomyelitis virus and Venezuelan equine encephalomyelitis virus. Vaccinations must be provided and administered by a licensed veterinarian with an established client-patient relationship to be eligible.

Dr. Susan O’Brien of Lebanon Equine Clinic in Lebanon, Ohio, recently utilized the Equine Immunization Support Guarantee program on behalf of a client’s horse that showed symptoms that could have been consistent with a lack of vaccine efficacy. When diagnostic test results were negative for the diseases covered by the program, Dr. O’Brien was able to modify her treatment accordingly and order additional tests to try to determine the source of the infection.
“Pfizer Animal Health covered all of the expenses related to the farm call and diagnostic testing for my client’s case,” Dr. O’Brien says. “I know that my client was relieved to have support with the costs due to therapy and screening, and I was able to make better-informed treatment decisions based on the diagnostic results.

The Common Horse Health Issues report gets you steered in the right direction and arms you with the knowledge you need to be a responsible horse owner.

“At the end of the day, a program like the Equine Immunization Support Guarantee gives me confidence that a manufacturer is committed to their products and working with me, the health care provider, to provide the most complete care for my clients’ horses,” Dr. O’Brien says.

All brands are the property of their respective owners. ©2012 Pfizer Inc. All rights reserved.

Merial offers tips to help horse owners sort out the different types of equine medicine.

From AQHA Corporate Partner Merial

Dr. April Knudson is an equine specialist with Merial Veterinary Services. She has a special interest in sport horse lameness and internal medicine. She holds a doctor of veterinary medicine degree from the University of California-Davis. Below, she answers a question about how to evaluate the products available to horse owners.

Question:

There are so many different versions of drugs available to purchase for my horse. How do I know which ones really work and are safe to use?

Answer:

As with any other area of equine health care, it is always best to consult with your veterinarian about providing the best possible medicine, including the risks and benefits of any product before giving it to your horse. There are many companies out there making claims that their products are “just like” others you may have used, but this is often just not the case.

When you decide to buy a product – specifically a drug – for your horse, it’s important to make sure you really know what you are getting. Having a better understanding of a few definitions may help as you and your veterinarian evaluate and make decisions about your horse’s health care.

Brand-name drug

Marketed under a proprietary, trademark-protected name and approved by the Food and Drug Administration (FDA), brand-name drugs must comply with the agency’s strict testing, manufacturing and labeling guidelines. FDA approval of a drug means:

• The product meets quality, purity and potency specifications.1
• Each unit is consistently manufactured under what is called “Good Manufacturing Practices.”¹
• The safety and efficacy of the product is based on thorough scientific review prior to approval.¹
• The drug is continually monitored by the FDA after it is on the market to ensure product performance, as well as identify any concerns or questions.¹
• Even if these drugs are not manufactured in the United States, the facilities they are made at are still subject to FDA approval and inspection.²
• These drugs are given a New Animal Drug Application number, and they can be found by searching a database accessed by doing an Internet search for “AnimalDrugs@FDA.”¹

Brand-name drugs may require a prescription or be available over-the-counter – but both types still require FDA approval. In the United States, horse owners are encouraged to go to the FDA site and search a drug’s name to make sure it has been manufactured to the standards they expect.

Did you know that you should never leave a semen shipping container in the sun? Although shippers are designed to maintain a constant internal temperature through a variety of weather conditions, it’s best to keep it in a cool spot. Learn more in AQHA’s FREE Mare Care: Breeding Tips report.

Generic drug
Generic is frequently a misused and misunderstood term. A generic drug, for which FDA approval is still required, must contain the same active ingredients as the original formulation.3 The generic must also be comparable to the brand-name drug in dosage form, safety, strength, route of administration, quality and intended use.3

A generic is not the same as a compounded drug, nor does it simply mean an over-the-counter version of a prescription drug. Upon FDA approval, generic drugs are given an Abbreviated New Animal Drug Application (ANADA) number.1 Sadly, some horse owners are led to believe that drugs they find online or from alternative sources are true generics, but often these products have not been reviewed by the FDA and are from unapproved foreign or U.S. sources that have not gone through safety or efficacy testing.

For example, despite what has been claimed in some product promotions,4-6 there are no generic versions of Ulcergard (omeprazole) or Gastrogard(omeprazole). In the United States, Ulcergard is the only FDA-approved product for the prevention of equine stomach ulcers,7 and Gastrogard is the only FDA-approved product for the treatment of equine stomach ulcers.8

If you have been told an omeprazole-containing product you are using is a “generic” of these products, you can be assured that is false. Just ask for the ANADA number. A quick visit to AnimalDrugs@FDA would confirm if this drug has been approved by the FDA. If not, you have no guarantees of what may or may not be in that product – or in what type of conditions it has been manufactured.

Compounded drug
Compounding is an equally confusing topic for horse owners. Contributing to that confusion is the fact that some product compounding is legal, while other compounding practices may not be.

Legal compounding is the manipulation of an FDA-approved drug for the purpose of meeting the needs of a specific patient.1 For a drug to be legally compounded and made available to a horse owner, the following rules apply: a valid veterinarian-client-patient relationship exists, a licensed veterinarian or pharmacist must compound the product, and there must not be an FDA-approved drug available.1  Examples of legal compounding include crushing a pill to create an oral suspension, adding a flavor to a commercially accessible drug or mixing two different injectable drugs together.¹

Unfortunately, many equine drugs, including Ulcergard and Gastrogard, Adequan, Banamine, Phenylbutazone, Protazil and Regu-Mate are illegally manufactured under the guise of compounding and marketed to horse owners. It is important for horse owners to know compounded products are not approved by the FDA. Nor are compounders required to comply with the FDA’s safety, efficacy and manufacturing guidelines, which help ensure the quality, purity and potency of FDA-approved products.¹ For example, there have been multiple studies showing that compounded omeprazole products are not as effective and often have great variations in the amount of active ingredient vs. what the label claims.9,10

Learn the steps for preparing your mare for breeding and get the facts on receiving shipped semen AQHA’s FREE Mare Care: Breeding Tips report shows you how.

Nutraceutical

Horse owners also have access to many nutritional and dietary supplements, sometimes called nutraceuticals.¹¹ These products are regulated by the FDA but cannot make drug claims such as “treat, heal, control or protect.” However, a significant number of these products make claims that cannot be substantiated by scientific data.¹²  Horse owners should be wary of using these products as a replacement for drugs that have undergone more extensive and critical scientific review. It’s never a bad idea to ask the manufacturer for peer-reviewed, published data that supports the product claims. It’s another step in the purchase process, but it’s an important one.

With all of this information, it’s no wonder owners often feel confused about what products to buy for their horses. Tips that will help you navigate this maze include consulting with your veterinarian, doing your homework and asking questions if you’re unsure or if product claims seem too good to be true. What you learn could make a difference in your horse’s health, and in the long run, your pocketbook.

For more information about Ulcergard and Gastrogard, visit www.ulcergard.com and www.gastrogard.com.

IMPORTANT SAFETY INFORMATION: CAUTION: Safety of Gastrogard in pregnant or lactating mares has not been determined. Ulcergard can be used in horses that weigh at least 600 pounds. Safety in pregnant mares has not been determined.

Gastrogard and Ulcergard are registered trademarks of Merial Limited. All other marks are the property of their respective owners. ©2012 Merial Limited, Duluth, GA. All rights reserved. EQUIUGD1204 (01/12)

¹ Animal Health Institute and American Veterinary Medical Association and American Veterinary Distributors Association. Veterinary Compounding. Available at: http://www.aaep.org/siteadmin/modules/page_editor/images/files/AHI%20 Compounding.pdf. Accessed February 9, 2012.

² U.S. Department of Health and Human Services. Food and Drug Administration. FDA Basics. How does FDA oversee domestic and foreign drug manufacturing? Available at: http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194989.htm. Accessed February 29, 2012.

³ U.S. Department of Health and Human Services. Food and Drug Administration. What are generic drugs? Available at: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicine
Safely/UnderstandingGenericDrugs/ucm144456.htm. Accessed February 29, 2012.

4 Omeprazole Direct Website. http://equine.omeprazoledirect.com/. Accessed February 9, 2012.

5  Canada Generic Website. http://www.canadageneric.com/index/cfm./fuseaction/product.display/pn/
ulcergard/product.display/pn/ulcergard/product.id/9697.htm. Accessed February 9, 2012.

6 OTCVetMeds Website. http://www.otcvetmeds.com/equine-stomach-ulcers/gastrogard.html. Accessed February 9, 2012.

7 Ulcergard product label.

8 Gastrogard product label.

9 Stanley SD, Knych HK. Comparison of Pharmaceutical Equivalence for Commercially Available Preparations of Omeprazole. AAEP Proceedings. 2011;57:63.

10 Nieto JE, et al. Comparison of paste and suspension formulations of omeprazole in the healing of gastric ulcers in racehorses in active training. JAVMA. 2002;8:1-5.

¹¹ Pharmaceutical Market Research. Nutraceuticals for The Animal Health Industry. Market Research Report. January 2007. Available at: http://www.pharmaceutical-marketresearch.com/publications/animal_veterinary/nutraceuticals_animal_health_industry.html. Accessed February 9, 2012.

¹² Crandell K, Duren S. Nutraceuticals: what are they and do they work? Kentucky Equine Research, Inc. Available at: http://www.ker.com/library/advances/203.pdf. Accessed February 1, 2012.

Is your horse protected from mosquito-borne diseases?

Protect your horse by ensuring that they receive their spring vaccinations. Journal photo.

From AQHA Corporate Partner Pfizer Animal Health

Spring has sprung early in many regions of the country. With the cherry blossoms, green grass and tulips also comes April showers and mosquitoes. In 2011, there were 65 cases of eastern equine encephalomyelitis reported in 11 states throughout the northeastern and southeastern regions, as well as mid-western regions such as Wisconsin and Michigan¹. There was also one case of western equine encephalomyelitis reported in Arizona in 2011¹. Is your American Quarter Horse at risk of contracting one of these mosquito-borne diseases?

The risk of exposure and geographic distribution of eastern equine encephalomyelitis varies from year to year with changes in distribution of insect vectors and reservoirs important to the natural ecology of the virus2.  However, unvaccinated horses may be at serious risk of contracting mosquito-borne illnesses, even in areas where the disease may not be common.  Eastern equine encephalitis is considered to be endemic in all areas of North America by the American Association of Equine Practitioners, and all horses should be vaccinated against it.

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Symptoms in horses that have eastern equine encephalomyelitis can be varied but usually begin with fever, depression and listlessness, which then progress to more serious neurological signs such as incoordination, stumbling, circling, head pressing, coma and often death³. Once the horse becomes infected with the eastern equine encephalomyelitis and develops neurological signs, the disease is fatal in roughly 90 percent of cases⁴. There is no effective treatment, and seizures resulting in death usually occur within 48-72 hours of the horse’s first indication of illness³.

Vaccinations are the most effective way to help protect horses against eastern equine encephalomyelitis and other encephalitic diseases, such as western equine encephalomyelitis and West Nile virus. According to AAEP’s vaccination guidelines, eastern equine encephalomyelitis, western equine encephalomyelitis and West Nile virus are considered core diseases for all horses, along with tetanus and rabies2. For adult horses previously vaccinated against eastern equine encephalomyelitis, annual revaccination should be completed in the spring prior to mosquito season. In animals at high risk or with impaired immunity, more frequent vaccination or appropriately timed vaccination is recommended in order to help induce protective immunity during periods of likely exposure. It is best to consult a veterinarian on your horse’s vaccination program, as timing and frequency may vary depending on age, geographic location, use and whether the horse has been previously vaccinated.

Pfizer Animal Health offers the INNOVATOR® line of vaccines, including the Mosquito Shot ™ (WEST NILE-INNOVATOR® + EWT), which helps protect against eastern equine encephalomyelitis, western equine encephalomyelitis, West Nile and tetanus in a single vaccine. Protection from eastern and western equine encephalomyelitis and tetanus is also available in combination with FLUVAC INNOVATOR®. The INNOVATOR vaccines, along with other Pfizer Animal Health equine vaccine combinations, are included in the Equine Immunization Support Guarantee.

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The Pfizer Animal Health Equine Immunization Support Guarantee program provides up to $5,000 for reasonable diagnostic and treatment costs if a horse properly vaccinated by a veterinarian contracts the corresponding equine disease. Disease protection backed by the Equine Immunization Support Guarantee includes infection from West Nile virus, equine influenza virus, tetanus, eastern equine encephalomyelitis virus, western equine encephalomyelitis virus and Venezuelan encephalomyelitis virus. Vaccinations must be performed by a licensed veterinarian with an established client-patient relationship to be eligible.

Ensuring that all horses get their spring vaccinations is the best way for horse owners to help protect their horses.

References:

1. Disease Maps 2011. U.S. Department of the Interior. U.S. Geological Survey. Available at: diseasemaps.usgs.gov/eee_us_veterinary.html. Updated December 14, 2011. Accessed   March 26, 2012.
2. Core Vaccination Guidelines. American Association of Equine Practitioners. 2008. Available at: www.aaep.org/core_vaccinations.htm. Accessed March 26, 2012.
3. Crans WJ. Questions Regarding Eastern Equine Encephalitis and Horse. Rutgers Center for Vector Biology. October 1 1993.  Available at: www.rci.rutgers.edu/~insects/heee.htm. Accessed on March 26, 2012.
4. Eastern/Western Equine Encephalomyelitis. American Association of Equine Practitioners. 2008. Available at: www.aaep.org/eee_wee.htm. Accessed March 26, 2012.

If your horse is exhibiting these signs, it might be time to call your veterinarian.

Changes in hair coat is a sypmtom of PPID. Photo courtesy of Dr. Patrick McCue.

From The American Quarter Horse Journal

Question:

Now that the days are getting longer, and warmer, most of my horses are shedding, except for my older gelding. Last year, he kept a really long hair coat, too. My friends have mentioned that he may have Cushing’s disease – how can I tell if he does?

For our answer, we turned to the April 2012 issue of The American Quarter Horse Journal and its feature, “Unharmonious Hormones.”

Answer:

Equine pituitary pars intermedia dysfunction is a hormonal disorder affecting the pituitary gland. Formerly known as Cushing’s disease, which is a similar disease that affects humans and dogs, it has been renamed to more accurately reflect the condition in equines.

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The pituitary gland, located near the base of the brain, controls numerous body functions via hormone secretion. In a horse with PPID, the middle lobe of the gland becomes enlarged and secretes excess hormones. This causes a cascade of problems throughout the body.

PPID affects aged horses, typically 15 and older. Symptoms might be mild and hard to notice, especially in early stages.

Common symptoms of PPID include:

•    Changes in hair coat: slow to shed, shed incompletely or in patches, shed late or grow hair early, develop long, curly hair
•    Muscle loss along the topline
•    Increased thirst and urination
•    Difficulty thermoregulating: sweating excessively or not at all
•    Quieter attitude
•    Unexplained infections
•    Chronic laminitis

If you suspect your horse has PPID, contact your veterinarian for a checkup. Have a history on the horse available, including shedding patterns and his or her typical water consumption.

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To learn more about PPID, or Cushing’s disease, and insulin resistance, be sure to read “Unharmonious Hormones” in the April 2012 issue of The American Quarter Horse Journal.

How a manufacturer’s program supports disease protection.

Protect your horse from disease. Journal photo.

From AQHA Corporate Partner Pfizer Animal Health

With the plethora of vaccine choices available today, horse owners have a wide range of options when vaccinating their American Quarter Horses. To help provide the most ideal disease protection based on regional risks and activities, horse owners should consult with their veterinarian to develop a thorough vaccination schedule. Utilizing the veterinarian-client relationship also has benefits beyond the initial vaccination. Manufacturer Pfizer Animal Health offers an Equine Immunization Support Guarantee.

With the Equine Immunization Support Guarantee, Pfizer Animal Health provides up to $5,000 for reasonable diagnostic and treatment costs if a horse properly vaccinated by a veterinarian with a Pfizer Animal Health vaccine contracts the corresponding equine disease. Disease protection backed by the Equine Immunization Support Guarantee includes infection from West Nile virus, equine influenza virus, tetanus, eastern equine encephalomyelitis virus, western equine encephalomyelitis virus and Venezuelan equine encephalomyelitis virus. Vaccinations must be provided and administered by a licensed veterinarian with an established client-patient relationship to be eligible.

If you’re confused about vaccinations, equine nutrition, first aid or anything else relating to horse health, then you need the “Your Horse’s Health” DVD collection.

So how does this program work? To find out, we interviewed Dr. Maureen Dower with Pfizer Animal Health’s veterinary medical information and product support department. Dr. Dower says the horse owner’s veterinarian should contact the veterinary medical information and product support team in any case where the horse owner suspects a lack of disease protection for a Pfizer Animal Health vaccine, as reported cases need to be investigated.

“When contacting their veterinarian regarding the illness of the horse, owners should note the horse’s current vaccinations so that the veterinarian can determine if the symptoms may match one of those diseases,” Dr. Dower says. “This allows the veterinarian to contact us and get the process started, as well as collect samples such as nasal swabs and blood during the initial examination.”

Pfizer Animal Health supports the veterinarian taking and processing the samples and diagnostic testing; there is no cost to the horse owner. Depending on the symptoms shown, the veterinarian may order tests for diseases not covered by the Equine Immunization Support Guarantee, such as rhinopneumonitis.

“We may provide testing options for diseases not covered by the program because symptoms often mimic other types of infections, and the veterinarian’s treatment decisions hinge on having the most complete information on the disease,” Dr. Dower says. “We are partnering with the veterinarian to help them provide the best possible care for their clients’ horses, and this program is only one facet of that commitment.”

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Dr. Dower also noted that testing for other infectious agents helps inform veterinarians of diseases that may be circulating in a specific region, allowing them to take steps to aid other clients in the area with similar risk profiles. The fees associated with the recommended diagnostic tests are always covered in an eligible Equine Immunization Support Guarantee case, but treatment costs are only covered if the tests show a positive result for the covered diseases. Horses also must be at least 1 year of age and must have been vaccinated by a veterinarian with a valid client relationship within a period of one year to be eligible for the program.

All brands are the property of their respective owners. ©2012 Pfizer Inc. All rights reserved.

Let’s talk about toothaches.

Equine dental care is a must-do. Journal photo.

By MaryAnna Clemons in The American Quarter Horse Journal

With 36 to 44 chances for a toothache, equine dental care isn’t just a should-do but a yearly must-do – and picking the right dentist for your horses is a delicate matter not to be taken lightly. As your mother (or father) used to say, “an ounce of prevention is worth a pound of cure.”

A horse’s teeth literally begin to erupt in the first few days of life, and a horse should be seen for problems at any age, as young as 6 months old. Horses’ teeth are called hypsodont teeth (having high or deep crowns and short roots, as in the molar teeth of a horse) that continue to erupt throughout a horse’s lifetime until the teeth are worn down to nothing. Taking care of a geriatric horse is a challenge unto itself, involving mashes, supplements and vigilance.

The goal of equine dentistry isn’t much different from human dentistry: perfecting what nature gave the horse, from crooked teeth to dental decay. Wild horses forage 16 to 18 hours a day under normal conditions, which allows their teeth to grind together and wear down the front teeth evenly, as well as the molars.

Because we often stall and feed horses, changing their natural grazing habits, their teeth often don’t wear the same, creating sharp points that can create problems. The front teeth can also wear unevenly, which can inhibit the proper intake and digestion of their food.

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As horse owners, it’s part of our responsibility to see that our horses’ needs are met, and the most important aspect of equine dentistry is prevention. Tooth loss in a horse is permanent. With regular check-ups, an equine dentist can find and correct other dental issues that can crop up as well, such as abscesses, ulcers, missing teeth, loose teeth, infected teeth or gums, periodontal disease, misalignment and abnormally long teeth.

Performance Issues

Horses that pull on the bit, shake their heads while being ridden, duck at the barrel or just act like they’ve never been trained (when you know better) may be having dental issues.

The horse that has in the past traveled with wonderful collection might begin to avoid a proper headset, or refuse a jump that has never been refused before. Often, with symptoms like these, the rider will check the saddle, change the bit, work the horse harder or even see a veterinarian about lameness issues, but often, it is really as simple as a toothache (or cheek-ache).

Horses that show weight loss, drop food, show quidding (cigar-shaped wads of hay balls that the horses stuff in sore places of their mouths to eat in more comfort), buck, chew the bit, have bad breath, wring their tails, tilt their heads or drool are exhibiting symptoms of a horse that needs to see the dentist.

Dr. Penny Lloyd, D.V.M., has specific training in equine dentistry beyond her original veterinary schooling, and she keeps up on the newest advances in equine dentistry by attending the yearly American Association of Equine Practitioners convention.
Before Dr. Lloyd starts on the dental work for two Quarter Horses, one 11 and one pushing 20, she checks their hearts, feels their faces for any bumps, swelling or signs of pain, and then she injects the first horse with just enough sedation to work, on the theory that a sedated horse is a happy horse that will not equate teeth floating with the end of the world, as well as making her job as an equine dentist that much easier.

“The horse doesn’t throw its head around and get hurt, the people on the ground don’t get hurt, and the horse does not fear me the next time I come to work on his teeth,” Dr. Lloyd says.

Using a full-mouth speculum, Dr. Lloyd starts her exam by feeling the inside of the mouth, front to back, and then looking farther inside with her light.

“(In the late 1980s), when I started, I learned by feel,” Dr. Lloyd says. “You’d hold a horse’s head up, pull their tongue to the side and use a flashlight, feeling about for loose teeth with a mirror and a pick. And while that worked at the time, I have since become a firm believer in the usefulness of the full-mouth speculum.”

After washing the horse’s mouth out with water, Dr. Lloyd grabs a specialized power drill with a sanding bit on the end of it and evens out the waves, points and misshapen teeth in the horse’s mouth. Seeker Sonny, 11, has an ulcer on his cheeks from sharp molar points and a wolf tooth that needs to be removed. While she is in there, Dr. Lloyd adds a bit seat to both sides of his mouth, which makes it more comfortable for the horse to hold a bit without getting any skin between the bit and the tooth.

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While working on 20-year-old “Cowboy,” Dr. Lloyd grabs her hand floater and places it on the side of his head to show just how far back she could reach with it. She cautions that Cowboy’s teeth are more sensitive due to his age, making it harder for him to chew foods like senior feed and cookie treats, and she recommends that his food be soaked in water before feeding.

After floating the teeth to a comfortable length, Dr. Lloyd grabs each horse’s jaw to “check the grind” by literally moving the top and the bottom of the jaw at the same time. As an accomplished equine chiropractor as well, Dr. Lloyd also checks the temporal mandible joint for any issues that might have arisen from using the full-mouth speculum.

The effects of the sedation are short-lived, and both horses are able to be transported safely about 20 minutes after Dr. Lloyd finished working on them. Dr. Lloyd cautions that the horses should not be allowed to eat until they got home (no hay bag in the trailer) and says she is available for follow-up calls or concerns.

Let’s Talk Cost

If there is anything inexpensive about owning horses, I haven’t found it yet. Equine dentistry is no exception. While costs vary from state to state, it’s a safe bet that you’ll spend at least $100 per horse if you are using a veterinarian who also is a dentist.

Sedation in this case was $25 a piece – and Cowboy, being the tough old bird that he is, needed two rounds. The floating was $85 per horse, and the wolf tooth extraction was a part of the floating cost. I had Dr. Lloyd throw in a chiropractic session for the old guy for another $125. Add that to $3+ a gallon fuel, and it adds up. The plus side is that most horses only need to be seen by the dentist once a year.

Beat mosquito season and keep your horse’s vaccinations up to date.

From AQHA Corporate Partner Pfizer

Journal photo.

Spring Shots

Keep your equine vaccinations schedule current with a vaccine booster before mosquitoes can have their say.

In many regions of the United States, the winter of 2012 has been unseasonably warm. Signs of spring are everywhere, from horses starting to shed their winter coats to daffodils beginning to sprout. Warmer temperatures also mean that mosquitoes will be back before we know it. Therefore, now is the time to talk with your veterinarian about what vaccines your horse may need before the mosquito season hits.

According to the American Association of Equine Practitioners vaccination guidelines, core vaccinations are those “that protect from diseases that are endemic to a region, those with potential public health significance, virulent/highly infectious, and/or those posing a risk of severe disease.” Every horse should be vaccinated against the core diseases, which include West Nile virus, eastern and western equine encephalomyelitis, tetanus and rabies.

All of these core diseases require revaccination annually. It is especially important to vaccinate against West Nile and eastern and western equine encephalomyelitis in the spring, before mosquitoes rear their ugly heads.

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According to the U.S Geological Survey, in 2011, there were 115 equine cases of West Nile reported in 29 states from the north, south, east and west regions of the United States. Also reported were 65 cases of eastern equine encephalomyelitis and one case of western equine encephalomyelitis2. Fortunately, due to annual horse vaccinations, the number of West Nile cases has decreased over the last decade. Widespread vaccination for West Nile virus began in 2002 with Pfizer Animal Health’s WEST NILE-INNOVATOR® vaccine. “It’s very important that all horses are properly vaccinated at least annually by a veterinarian with the core vaccines. Risk-based vaccines should be administered based on the individual horse’s risk and lifestyle,” says Dr. Tom Lenz, senior director of equine veterinary services for Pfizer Animal Health. “Every year, we continue to see mosquito-borne diseases in areas across the country. Horse owners should help protect their horses now by getting their spring shots.”

Pfizer Animal Health offers a trusted line of vaccines, including WEST NILE-INNOVATOR to help protect against West Nile virus. In addition, the Mosquito Shot ™ (WEST NILE-INNOVATOR® + EWT) helps protect against eastern and western equine encephalomyelitis, West Nile and tetanus in a single vaccine. These products and combinations are included in the Equine Immunization Support Guarantee (ISG).

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Pfizer Animal Health’s Equine Immunization Support Guarantee provides up to $5,000 for reasonable diagnostic and treatment costs if a horse properly vaccinated by a veterinarian contracts the corresponding equine disease. Disease protection backed by the Equine Immunization Support Guarantee includes infection from West Nile virus, equine influenza virus, tetanus, eastern equine encephalomyelitis, western equine encephalomyelitis and Venezuelan equine encephalomyelitis. Vaccinations must be performed by a licensed veterinarian with an established client-patient relationship to be eligible.

Vaccinations offer the best protection in any preventative health care program. Any questions about your equine vaccination schedule should be discussed with a veterinarian.

The risk of barn fire increases significantly in winter.

Search your barn for fire risks and correct them. Journal photo.

By Dr. Thomas R. Lenz for The American Quarter Horse Journal

When the weather grows cold and horses are moved indoors, the risk of barn fires increases dramatically. In the summer, lightning and spontaneous combustion of hay are primary causes of fire. In the winter, fire usually results from faulty heaters, electrical wiring problems or rodents chewing through wires.

Generally, a fire involving combustible materials such as wood, hay, straw and shavings doubles in size every minute – meaning you have about eight minutes to get your horses out of a burning barn. Even if the horses escape, smoke inhalation could cause permanent lung damage or even death. Prevention is paramount.

Search your barn for fire risks, correct them and keep them corrected.

11 Barn Fire Trouble Spots:

1. If possible, store hay in a building separate from the horse barn. Hay that was baled damp can build up internal heat and ignite spontaneously.
2. If hay must be stored in the barn, break a bale open every week or so to check for heat. If you feel heat between flakes of hay, remove the bales. Store the least amount of hay possible in the barn, preferably at the ground level and away from electrical wires.
3. Rodents living in hay love to gnaw through the coating around electrical wires, and exposed wires could start a fire. To prevent this, all electrical wires in the horse barns should be encased in metal conduits.
4. Light bulbs should have a metal mesh cage around them to prevent breaking.
5. Install a smoke detector or heat detector above the haystack.
6. Never store flammables such as gasoline and kerosene in the barn. Because many grooming aids, insecticides and leather-conditioning agents also are flammable, if the label says “flammable,” store the item away from the barn or in a fire-resistant metal tack box.
7. Store gas-powered garden tractors and lawn mowers elsewhere.
8. Clean the barn weekly and remove empty feed sacks, cobwebs and discarded hay.
9. Get rid of dust on space heaters and heat lamps; it can spontaneously combust.
10. Be especially careful with extension cords. Use the heavy-duty, industrial-rated type, and as soon as you’re finished with the task, unplug and put the cord away. Using one long cord is better than plugging several shorter cords together. If shorter cords must be used, tape the connections with electrical tape.
11. Put the manure pile some distance from the barn. Heat generated by decomposing manure can start a fire if combustible materials are near.

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With a barn free of potential fire hazards, focus on plans to detect and fight a fire.

Eight Steps to Barn Safety:

1. Install smoke detectors and check them peri­odically to make sure they work and the bat­teries are charged.
2. Place fire extinguishers at strategic points in the barn and inspect them regularly.
3. Install ceiling sprinklers where applicable, especially over stored hay and individual stalls.
4. Institute a “no smoking” policy, or limit smoking to areas away from the barn.
5. Ensure that all buildings have at least two easily accessible and unblocked exits.
6. Install hoses attached to water taps in the barn, especially if the property is in a remote area difficult for the fire department to access. Hoses should be large enough to shoot water up onto the barn roof.
7. Make sure everyone who lives and works on the property knows your fire evacuation plan and periodically conduct fire drills.
8. Because horse owners often have only their name on mailboxes, firefighters unfamiliar with the area might have trouble quickly locat­ing their property when responding to an alarm, so put your address on your mailbox.

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A fire in a horse barn is a devastating event. Reduce potential fire hazards and develop a quick and efficient disaster plan.