Reiner November 2013 : Page 172

FROM OUR CORPORATE PARTNERS Don’t Take for Granted “FDA-APPROVED” he United States enjoys one of the safest sup-plies of food and drugs in the world. Since the early 1900s, the US government has been regulating that supply to minimize misrepresen-tations and major abuses in the food and drug industries. While the Food and Drug Administra-tion (FDA) creates a sense of security by prohibit-ing misbranding and adulteration of foods and drugs, security can breed carelessness. While the regulations and enforcement of those regulations still keep America’s food and drugs safe, there are a lot of animal health prod-ucts on the market that aren’t approved by the FDA. Just because you can buy it for your horse, doesn’t mean its FDA-approved or safe. “A lot of people believe what’s on the bottle,” says Dr. Joe Bertone, a Professor of Equine Med-icine at the Western University of Health Sci-ences. “That has to do with the U.S. having an FDA for more than 70 years. Back at the turn of the century, people always questioned what was in the bottle because there was no one there to tell them the bottle actually contained what was on the label.” Some companies are using loopholes to pro-mote substances that aren’t FDA-approved. This is creating some confusion for consumers. What are veterinary medical devices and compounded drugs? What are they supposed to be used for? WHAT ARE DEVICES? “Look for an NADA number, a package insert with “FDA-ap-proved” claims and a label that says FDA-approved,” Dr. Bertone says. T A human medical device must go through the Center for Disease Control (CDC) and is essentially an object or substance not intended to change in the body. Screws for surgery, contact lenses and x-ray machines are examples of devices. Vet-erinary devices don’t have to go through the CDC. The Center for Veterinary Medicine (CVM) regulates those, but has chosen to not enforce the regulation. In other words, no one polices veterinary devices in anyway. “If I take a nail and say this is a veterinary medical device, the CVM FDA doesn’t bother to regulate it,” says Dr. Bertone, who was a Veteri-nary Medical Officer at the Center for Veterinary Medicine in the FDA for five years. “That’s why there are ultrasound machines that don’t have the specifications necessary to be a cardiac ma-chine, but are being sold to veterinarians as car-diac machines. The sellers just call it that, knowing the public, including veterinarians, don’t understand the issue. They are calling it a veterinary device so that no one will oversee them. As long as they don’t say they are a drug the FDA won’t enforce the regulations.” Another example is Polyglycan® Sterile Solu-tion. It is a veterinary medical device and is la-beled as a post-surgical lavage. If used properly, it should only be used to wash out an opening after surgery; instead it is being used to replace Adequan® (polysulfated glycosaminoglycan), and Legend® (hyaluronate sodium) Injectable Solution. Adequan® and Legend® are FDA-ap-proved drugs that have been shown to be safe and effective and have the substances within them that the label says they do, by FDA en-forcement of manufacturing. Polyglycan® Ster-ile Solution has never been shown to meet the standards of an FDA drug and they have never been approved for content of the bottle nor manufacturing because they are marketed as a veterinary medical device. In other words, there is no one that assures you what’s in the bottle, from batch to batch, or if the product is safe and effective. You are using it on the manufac-turer’s word.

Adequan®

Don't take FDA-approved for granted.

The United States enjoys one of the safest supplies of food and drugs in the world. Since the early 1900s, the US government has been regulating that supply to minimize misrepresentations and major abuses in the food and drug industries. While the Food and Drug Administration (FDA) creates a sense of security by prohibiting misbranding and adulteration of foods and drugs, security can breed carelessness.

While the regulations and enforcement of those regulations still keep America's food and drugs safe, there are a lot of animal health products on the market that aren't approved by the FDA. Just because you can buy it for your horse, doesn't mean its FDA-approved or safe.

"A lot of people believe what's on the bottle," says Dr. Joe Bertone, a Professor of Equine Medicine at the Western University of Health Sciences. "That has to do with the U.S. having an FDA for more than 70 years. Back at the turn of the century, people always questioned what was in the bottle because there was no one there to tell them the bottle actually contained what was on the label."

Some companies are using loopholes to promote substances that aren't FDA-approved. This is creating some confusion for consumers. What are veterinary medical devices and compounded drugs? What are they supposed to be used for?

WHAT ARE DEVICES?

A human medical device must go through the Center for Disease Control (CDC) and is essentially an object or substance not intended to change in the body. Screws for surgery, contact lenses and x-ray machines are examples of devices. Veterinary devices don't have to go through the CDC. The Center for Veterinary Medicine (CVM) regulates those, but has chosen to not enforce the regulation. In other words, no one polices veterinary devices in anyway.

"If I take a nail and say this is a veterinary medical device, the CVM FDA doesn't bother to regulate it," says Dr. Bertone, who was a Veterinary Medical Officer at the Center for Veterinary Medicine in the FDA for five years. "That's why there are ultrasound machines that don't have the specifications necessary to be a cardiac machine, but are being sold to veterinarians as cardiac machines. The sellers just call it that, knowing the public, including veterinarians, don't understand the issue. They are calling it a veterinary device so that no one will oversee them. As long as they don't say they are a drug the FDA won't enforce the regulations."

Another example is Polyglycan® Sterile Solution. It is a veterinary medical device and is labeled as a post-surgical lavage. If used properly, it should only be used to wash out an opening after surgery; instead it is being used to replace Adequan® (polysulfated glycosaminoglycan), and Legend® (hyaluronate sodium) Injectable Solution. Adequan® and Legend® are FDA-approved drugs that have been shown to be safe and effective and have the substances within them that the label says they do, by FDA enforcement of manufacturing. Polyglycan® Sterile Solution has never been shown to meet the standards of an FDA drug and they have never been approved for content of the bottle nor manufacturing because they are marketed as a veterinary medical device. In other words, there is no one that assures you what's in the bottle, from batch to batch, or if the product is safe and effective. You are using it on the manufacturer's word.

Adequan
(Polysulfated Glycosaminoglycan)

WHAT ARE BULK COMPOUNDED PRODUCTS?

Bulk compounded products are products made from chemicals of varying quality. The quality and source of the chemical is dependent on the ethics and expertise of the compounding pharmacist. Compounded products allow veterinarians flexibility to treat a disease that doesn't have an FDA-approved alternative.

"There are times when a compounded product is absolutely necessary," says Dr. Bertone, former member of multiple FDA and AAEP committees. "If there isn't an FDA approved drug and a compounded drug is your only shot, then that's what you have to use. But you have to know you are using a product that does not have the same testing and quality standards that an FDAapproved product would have."

Compounded products are supposed to be mixed on the order of a veterinarian for a unique situation for one client. The problem is that many compounders are mixing batches and selling them in bulk, which is not only against the law, but it's likely not to help your animal or even lead to death, as has been seen.

"To be an FDA-approved product means you are absolutely sure that from batch-to-batch-to-batch, year-in and year-out when you buy a bottle that has not expired, you have that drug in the bottle," Dr. Bertone says. "It's been shown over and over again with the compounded drugs that from day-to-day the amount of drug in the bottle varies. The content can vary from the label from 0 to 150 percent and it can be contaminated with things that you do not want your horse to have. One study found a compounded drug that was 300 percent of what it said on the label. Another found 10 percent of unknown substances.

ARE THESE PRODUCTS LEGAL?

Whether a product is legal or not can be hard to determine if it is not FDA-approved. Like many other issues of legality, a loophole may make it legal, but not in the best interest of the end user.

"The legality is not the issue for me; it's the fair medical practice and service to the patient and owner. I care very little about whether it's legal because the law was written based on science," said Dr. Bertone, who served on the AVMA Council on Biologic and Therapeutic Agents. "The science and the practice of medicine is the better argument. I never use 'it's against the law' as the justification for my position. In reality the reason it's illegal is because it's not in the best interest of clients, or patients. It's a consumer safety issue."

WHAT TO LOOK FOR

Like many copycats, knowing the difference between an FDA-approved drug and a medical device or a compounded product is knowing what to look for.

"Look for an NADA number, a package insert with "FDA-approved" claims and a label that says FDA-approved," Dr. Bertone says. "I don't know why you would ever use a compounded drug or medical device when there is an FDA-approved product for that disease. No one should have confidence in a product that isn't FDA approved."

If you are confused or unsure, Dr. Bertone suggests you, "Google it." If the drugs' website doesn't have an "FDA-approved" label, an NADA number somewhere or a downloadable product insert, it's probably not FDA approved. If that's the case, then you need to ask, what's really in that bottle and how do I know?"

There are no known contraindications to the use of intramuscular Adequan® i.m. brand Polysulfated Glycosaminoglycan in horses. Studies have not been conducted to establish safety in breeding horses. WARNING: Do not use in horses intended for human consumption. Not for use in humans. Keep this and all medications out of the reach of children. Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Each 5 mL contains 500 mg Polysulfated Glycosaminoglycan. Brief Summary Indications: For the intramuscular treatment of non-infectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal and hock joints in horses. SEE PRODUCT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION.

Adequan® is a registered trademark of Luitpold Pharmaceuticals, Inc. ©LUITPOLD PHARMACEUTICALS, INC., Animal Health Division, Shirley, NY 11967.

Read the full article at http://digitaleditions.sheridan.com/article/Adequan%C2%AE/1549436/181548/article.html.

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