Use Caution with Extra-Label Use

By : Jill J. Dunkel


Administering products off-label can result in decreased efficacy and withdrawal concerns

Thanks to educational programs and information, as well as an industry-wide push for beef quality assurance, the eating  experience for consumers has increased in both quality and consistency. Injection site education, following withdrawal times, pharmaceutical mode of application options, cattle handling and other improvements have helped the industry significantly
since the early 1990s.

According to BQA educator Dr. Ron Gill, following beef quality assurance guidelines are not only good for the industry, but also for the cattle owner. Following label directions for route of administration ensures pharmaceutical products work like they are designed to and minimize tissue damage.

“If you’re going to take the effort and expense to give a product, administering it according to label directions will help ensure it’s going to work as intended. If you don’t deliver it correctly, you might not get the results you expect,” Gill said.

Once you go off label, you don’t know the absorption rate,  withdrawal time and efficacy of the product, he said.

A similar issue occurs when too much of a product is injected in one place. Most products recommend no more than 10cc at a single injection site location. More than 10cc can lead to the product not being absorbed appropriately.

Improper injection techniques can also increase tissue damage resulting in more trim on the carcass and will affect the tenderness of meat in the area of an intra-muscular injection. “That’s why all IM injections should go in the neck,” Gill states.

A new product released in February hopes to make it easier for cattlemen to use and follow label directions, insuring an accurate withdrawal time and efficacy when administered correctly. Banamine Transdermal (flunixin  transdermal solution) from Merck Animal Health offers a new pour-on route of administration, compared to traditional injectable flunixin meglumin.

Banamine Transdermal is the first and only non-steroidal, antiinflammatory (NSAID) cattle  product available as a pour-on, and the first product ever to be licensed with a pain indication for food animals.

Flunixin  meglumin injectable products are labeled for intravenous (IV) use in cattle, and have a four-day withdrawal. Because IV administration can be difficult, the injectable product has often been administered either IM or SQ, which can change the  withdrawal to as much as 60 days, according to Scott Nordstrom, DVM, Assistant Director of New Product Discovery and Development for Merck Animal Health.

According to the FDA, extra-label use of drugs without written direction by a  veterinarian in foodproducing animals is a significant public health concern and a contributing factor in illegal residues in edible animal tissue. Such use of drugs is illegal under the Federal Food, Drug, and Cosmetic Act.

Flunixin meglumine has been one of  the common causes of meat residue violations in cattle. According to Nordstrom, “Merck Animal Health understands the  importance of flunixin meglumine’s use in treating cattle and worked to find an easier way to administer it. The pour-on  application eliminates injection-site lesions within the carcass at marketing and reduces risk of residues, resulting in a  significant improvement in food safety.”

Good record keeping is key to protecting yourself in the event of a residue violation,  Gill said. “If it’s your first violation, they will often see what your records are, and if you’re trying to follow guidelines. Repeat  offenders can be fined and habitual violators can ultimately be banned from owning livestock,” he said.

“Even if you are  administering a product to stocker cattle that you think wouldn’t enter the food chain for several months, withdrawal times are  important,” said Gill. “If you’re giving something off label, you can have a withdrawal issue. If one of those stocker claves had to be harvested early, then a residue could be in the meat. You can’t assume that calf would go to another rancher or stocker  operator. Once they leave your property, you have no control whether they enter the food chain or not.”

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