Kenalog NOT for epidural use?!?!?!?

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Rehability

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Hi all,

So I looked at my bottles of Kenalog today and to my surpise the side said in bold letters: Intramuscular or intra-articular use only. Not for IV, ID, intraocular, epidural, or intrathecal use.

This is the same Kenalog-40 made by Bristol-Myers Squibb that I have used throughout the years for my epidural injections.

By chance, I had an old bottle of Kenalog sitting around and it did NOT have the epidural restriction (and by the way, the item number on the 2 bottles was IDENTICAL).

I spoke with the medical information specialist at Bristol-Myers Squibb. Here's the story:

In June 2011 they changed their Packaging Information for Kenalog. Here is an abridged version of the info contained within:


Neurologic

Epidural and intrathecal administration of this product is not recommended. Reports of
serious medical events, including death, have been associated with epidural and
intrathecal routes of corticosteroid administration (see ADVERSE REACTIONS:
Gastrointestinal and Neurologic/Psychiatric).


Neurologic/Psychiatric: Convulsions, depression, emotional instability, euphoria,
headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually
following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy,
paresthesia, personality changes, psychiatric disorders, vertigo. Arachnoiditis, meningitis,
paraparesis/paraplegia, and sensory disturbances have occurred after intrathecal
administration. Spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and
stroke (including brainstem) have been reported after epidural administration of
corticosteroids (see WARNINGS: Neurologic).


So sounds like it's the same Kenalog we've been using for years, but now the company that makes it is covering their behinds by saying we warned you not to inject it into the epidural space in the event there is a complication. So the liability falls on your shoulders as the treating physician (I guess this can be considered an "off-label" usage of kenalog now).

Do you guys use another type of particulate steroid for your epidurals? Do other makers now indicate that they are NOT to be used for epidural injections? Depo-Medrol?

I know dexamethsone is non-particulate and "safer", but it doesn't provide as much relief.

Are you guys still using Kenalog? By the way, I DO NOT perform cervical transforaminal injections because of the current risks, only cervical interlaminars...but I have been doing lumbar transforaminals using kenalog.

Any advice would be greatly appreciated.
 
Dude (or dudess), we have been discussing this at length. Do a search. I am usually the last one to say that but a simple search (which actually occurs automatically when you submitted this thread) would have answered your query

Bottom line: yes it is off label, yes so are other injectables, no it doesn't make sense, and yes you will have to decide for yourself if you want to keep using it
 
fda black box warning
not off label, label clearly says don't put it into epidural space
 
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