Doctors’ Extra-Label Use Of Medication

Today’s post is a followup to a previous post you may also wish to read, on Workups Of Dog Urinary Tract Infections.

Reader Meghan writes:
My 15lb female non-spayed Westie/Pomeranian mix had a UTI in April. She was treated with an injection and then given 2 weeks of oral Rx. The UTI went away about 10 days after the medicine was finished. However, she now has a UTI again. This time, the veterinarian gave her Convenia. I’m noticing on the label that it’s not intended for UTI. Is this ok, and will it work? The shot was 4 days ago and if anything her UTI is worse. Her last puddle I found was almost pure blood but it appeared to have a gel-like texture in parts. The dog never seems to be uncomfortable, but she squats about 10 times when I let her out and can barely pass any urine. Thanks in advance, Meghan

Doctors have wide leniency in use of legal medications thanks to a policy known as “off-label use” or “extra-label use.”

Convenia is an excellent choice for bacterial infections in dogs and cats.

Convenia is an excellent choice for bacterial infections in dogs and cats.

Essentially, off-label use means that we can use a medication for any condition for which it is legal, ethical and medically justified.

That last parameter, medically justified, is the factor that requires the strongest defense. Obviously, few doctors are going to do something that is illegal or unethical, but when it comes to using medication for purposes for which the federal Food and Drug Administration (FDA) has not approved it, the rules are very strict.

If asked to justify extra-label use, a practitioner must be prepared in advance to defend his decision to use a medication off-label instead of previously approved medications.

For a drug to be approved for a certain disease process the applying company must prove that the drug is both safe and effective. Each disease for which approval is sought requires additional steps and, thus, additional cost. Therefore, medications are often approved for one indication, knowing that physicians and veterinarians will use the drug for other uses as well.

In some cases approval for additional indications will be sought after initial approval for a single illness.

Reader Meghan writes to ask since Convenia is not approved for urinary tract infections, will it be effective in her kitty, who has a UTI?

Convenia is a safe, broad-spectrum antibiotic in the cephalosporin family. It is approved for skin infections (surface and abscesses) in dogs and cats. Veterinarians use it for just about every kind of infection you can name: skin, respiratory tract, urinary tract, etc.

Time has proven its broad safety profile as well as its effectiveness in these various organ systems.

So, readers can rest easy, knowing that the chances are good that if your pet has an antibiotic-responsive disease process, she should heal without complications.

Another example of common extra-label use is the drug Atopica, by Novartis Animal Health. It is approved for use in canine Atopy (Allergic Inhalant Dermatitis), yet practitioners use it every day for other types of allergies in dogs.

Cosequin is a neutraceutical approved for use in arthritis of dogs and cats, yet we commonly use it for Feline Lower Urinary Tract Disease (FLUTD) and get remarkable results in some carefully-chosen patients.

We could go on for pages with more examples, but you have the idea. Still, don’t be shy about asking your pet’s doctor about any questions or concerns you have. We are always happy to clarify any aspect of care for the pets we consider family.

covenia, convina, convinia, covinia

2 Comments to “Doctors’ Extra-Label Use Of Medication”

  1. Jeanne Crowley 11 July 2010 at 4:45 pm #

    Dr Randolph – What a treat! You do a fabulous job here and I so appreciate the kudos to your team for extra effort. When I return to the coast I will NOT be empty handed. I will bring some extra copies of PQ. Promise.


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