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Drugs are officially approved to be used for certain things, and they may be approved for one thing in one country but something else entirely in another.1

Meds are often prescribed for conditions (e.g. Topamax for bipolar disorder), or people (e.g. adolescents being prescribed any SSRI or SNRI except Prozac or Lexapro) they aren’t approved to treat. This is known as off-label prescribing. Some off-label prescribing is so common that lots of people think the medication is a first-line treatment for the condition it’s prescribed to treat (e.g. Trileptal for bipolar disorder). If a drug company’s sales force (a.k.a. pharm reps) is too aggressive in pushing a med for off-label applications where it doesn’t work as well as people think, the FDA will now come down hard on them (e.g. Novartis getting heavily fined for promoting Trileptal as a treatment for bipolar disorder).

Off-label prescribing is not necessarily bad. Drugs that almost, or would almost, pass a clinical trial still work for a lot of people.

1.  Keppra-XR is US FDA-Approved to Treat:

  • Keppra-XR (Extended Release): as adjunctive therapy (combined with another medication) in the treatment of partial onset seizures in patients 16 years old or older with epilepsy.
  • Keppra (immediate release/IR) & oral solution:
  • Injection for Intravenous Use (IV). The same as the IR version, except:
    • It’s approved only for people 16 years old and older.
    • It’s to be used only if someone isn’t able to take the tablets or drink the vile-tasting grape Keppra-Ade.
    • IV Keppra isn’t intended for long-term use, and should be replaced by a tablet or oral solution form as soon as possible.

2.  Keppra-XR (levetiracetam) is Approved Elsewhere for:

3.  Clinically Significant or Otherwise Common Off-Label Uses of Keppra-XR (levetiracetam):

Boy do we have off label uses! Keppra is like Neurontin, in that it’s being prescribed for practically anything (these guys certainly want to throw it at everything). Unlike Neurontin, it works…but when used for something other than epilepsy it usually needs one thing to work. See if you can figure it out.

Figure it out? The magic word: refractory. Keppra is the go-to drug when nothing else will work, or whatever you take barely works.

See the page on Keppra-XR’s efficacy for details on the likelihood Keppra-XR will work for approved indications and off-label uses.

Just because a medication is approved or commonly prescribed for a particular condition doesn’t necessarily mean you should be taking it for that condition. There could be a drug that might be better to try first, or at least talk to your doctor about trying first, such as Topamax instead of Depakote as a daily med to prevent migraines (and Topamax has its own reasons why you should and should not take it). Or the condition you have isn’t bad enough to warrant medication at all. E.g. any antidepressant if you’re not so depressed that you can function at relatively the same level as you do when you’re not depressed.

4.  When/Why You Should Take Keppra-XR

  • Your neurologist said so.
  • You have brain cancer.
  • Your liver is next to useless.
  • All the usual meds failed or barely work.

5.  When/Why You Should NOT Take Keppra-XR

  • You’re currently severely depressed.
  • You have a history of psychosis (One off-label use nobody dares try: Keppra for schizophrenia).
    • Especially if you have a history of psychosis caused by AEDs.
    • Extra especially if the psychosis happened after your seizures were under control.

When all else fails and you’ve run out of other options, Keppra-XR may be your last best chance at treating an obscure or treatment-resistant condition.
Be careful! Otherwise safe meds can be downright dangerous when used for some things.

6.  Less Common/Experimental Off-Label Uses of Keppra-XR

7.  Failed Off-Label Uses

Alas, Keppra doesn’t work for absolutely everything. There are some things it can’t deal with.

8.  Potentially Dangerous Off-Label Uses

‹ Brand and Generic Availability | Keppra-XR Index | How Long & How Likely To Work, Comparisons with Other Meds ›
Crazy Meds Comprehensive Keppra-XR pages

Bibliography

1 Before Cymbalta (duloxetine) was approved as an antidepressant in the US it was already approved in the EU, but only for stress urinary incontinence and sold under the trade name Yentreve. Duloxetine is now sold in the EU as an antidepressant under the trade name Cymbalta.
A better known, if slightly different example is bupropion. According to the 2007 edition of Mosby's Drug Consult, in the US, Canada and Singapore you can get both Wellbutrin (bupropion) as an antidepressant or as Zyban (bupropion) to stop smoking. In Korea, Thailand and most of South America (but not Brazil) you can get bupropion (under various trade names) only as an antidepressant. In Brazil, the EU & UK, Israel, India, Australia and New Zealand it's only available as Zyban to help you stop smoking.



Date created Tuesday, 04 October 2011 at 11:12:28 Page Creator: Last edited by: JerodPoore

Keppra-XR Approved and Off-label Uses by is copyright 2011


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1 While there are plenty of books to help you with hypochondria, for some reason there’s not much in the way of websites. Then again, staying off of the Internet is a large part of curing/managing the disorder.

2 Have I mentioned how open source operating systems for commercial applications is one of the dumbest ideas in the history of dumb ideas?
[begin rant] I rent a dedicated server for Crazy Meds. It’s sitting on a rack somewhere in Southern California along with a bunch of other servers that other people have rented. The hardware is identical, but no two machines have exactly the same operating systems. I don’t even need to see what is on any of the others to know this. If somebody got their server at the exact same time, with the exact same features as I did, I’m confident that there would be noticeable differences in some aspects of the operating systems. So what does this mean? For one thing it means that no two computers in the same office of a single company have the same operating system, and the techs can spend hours figuring out what the fuck the problem could be based on that alone. It also means that application software like IP board that runs the forum here has to have so many fucking user-configurable bells and whistles that even when I read the manual I can’t find every setting, or every location that every flag needs to be set in order for a feature to run the way I want it to run. And in the real world it means you can get an MBA not only with an emphasis on resource planning, but with an emphasis on using SAP - a piece of software so complex there are now college programs on how to use it. You might think, “But don’t people learn how to use Photoshop or Adobe Illustrator in college?” Sure, in order to create stuff. And in a way you’re creating stuff with SAP. But do you get a Bachelor of Fine Arts degree with an emphasis on Photoshop?
Back in the Big Iron Age the operating systems were proprietary, and every computer that took up an entire room with a raised floor and HVAC system, and had less storage and processing power than an iPhone, had the same operating system as every other one, give or take a release level. But when a company bought application software like SAP, they also got the source code, which was usually documented and written in a way to make it easy to modify the hell out of it. Why? Because accounting principles may be the same the world over, and tax laws the same across each country and state, but no two companies have the same format for their reports, invoices, purchase orders and so forth. Standards existed and were universally ignored. If something went wrong it went wrong the same way for everyone, and was easy to track down. People didn’t need to take a college course to learn how to use a piece of software.
I’m not against the open source concept entirely. Back then all the programmers read the same magazines, so we all had the same homebrew utilities. We even had the forerunner to QR Code to scan the longer source code. Software vendors and computer manufacturers sponsored conventions so we could, among other things, swap recipes for such add-ons and utilities. While those things would make our lives easier, they had nothing to do with critical functions of the operating system. Unless badly implemented they would rarely cause key application software to crash and burn. Whereas today, with open source everything, who the hell knows what could be responsible some part of a system failing. [/end rant]


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