approved indications and clinically-significant off-label uses, as well as experimental and failed applications
Copyright, Citing and License information Published online 04 October, 2011
I Forgot Why I Cake Topamax
Psychopharmacological Need for Approval
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 for some indication still work for a lot of people. As long as the reason for not clearing the hurdles of phase III clinical trials wasn’t the death of too many participants, or some other intolerable side effect.
Keppra 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:
- as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years old and older with epilepsy.
- as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years old and older with juvenile myoclonic epilepsy (JME).
- as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.2
- 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.
Keppra (levetiracetam) is Approved Elsewhere for:
Clinically Significant or Otherwise Common Off-Label Uses of Keppra (levetiracetam)
- Monotherapy for partial epilepsies.
- Including motor and sensory epilepsia partialis continua (EPC). EPC is one of the scariest and weirdest things to witness or experience.
- Monotherapy for generalized epilepsies, including:
- post-hypoxic and post-encephalic myoclonus
- negative myoclonus
- Various idiopathic myoclonic, tonic-clonic and/or absence seizures.3
- absence seizures - plus a good example of what happens if you suddenly stop taking Keppra, and how Keppra will forgive you and work just as well.
- and the dreaded Lennox-Gastaut syndrome. With a 50% to 100% reduction of certain seizure types along with an increase in the kids’ alertness. Talk about win-win!
Injury & Tumor-Induced Epilepsy
- Keppra is also used for seizures and other damage caused by traumatic brain injury, where it’s as good as Dilantin (phenytoin), the gold standard med.
- Keppra is also good for tumor-induced epilepsy.
- It’s really good for tumor-induced epilepsy.
- Including preventing seizures prior to and during surgery.
- And stopping the seizures in children with brain tumors without interfering with any of the chemo and other meds they take.
- And stopping the vomiting caused by chemo along with stopping the seizures.
- Keppra just generally improves the quality of life of people with brain tumor-related epilepsy.
- When you’ve got 75 of 82 patients (91%) seizure free
- and Keppra could actually help prevent some forms of brain cancer from spreading so UCB damn well better be doing more clinical trials for another approved indication! If they don’t want to pay for it some cancer research charity should.
- Naturally enough IV Keppra is used to deal with status epilepticus.
- It works best when used immediately and by itself.
- In case you haven’t cried enough lately, IV Keppra works well for critically ill children who have gone into status. Too bad they still need to keep collecting data one kid at a time to figure out the best way to use it.
- For bipolar disorder Keppra’s best used to deal with the most extreme, out-of-control manias you have around.
- Keppra stops mania fast, like an antipsychotic.
- Either as an add-on medication
- or all by itself.
- It’s worked for rapid cycling, but only when everything else didn’t.
- As with epilepsy, one of Keppra’s best features is that if you stop taking it, Keppra tends to work just as well if you stop it and restart it. So if you were crazy and thought you were cured, or because your manias are seasonal and you don’t need a potent anti-manic certain times of the year, Keppra has its place in the bipolar pharmacopeia.
Headaches and Other Aches and Pains
- Migraines, both in adults and kids.
- IV Keppra is good for status migrainosus - migraines that last for more than 72 fucking hours.
- Neuropathic pain, including:
- chronic pain in multiple sclerosis
- trigeminal neuralgia
- And as an adjunctive analgesic, along with traditional opiods, in neoplastic plexopathies - not like I have any idea what that is, other than it hurts a lot and it’s involved with cancer.
- The data are mixed when it comes to Keppra and anxiety disorders. In this study it looks pretty good, while in this study it’s just so-so, and in this study the placebo worked better.
- Like all anticonvulsants, Keppra is being tested as a means to get clean when hooked on other drugs. Alcohol seems to be the most promising, although the data are mixed.
- And Keppra is used successfully for all sorts of movement disorders:
- It works well for antipsychotics-resistant Tourette Syndrome
- But when it comes to Tourette Syndrome in general, the data are mixed.
- Along the same lines, Keppra seems to be great for levodopa-induced dyskinesia in Parkinson’s disease. There are a dozen small studies supporting that, but nothing about Parkinson’s itself.
- Tardive dyskinesia.
- Meige’s syndrome.
- Generalized dystonia.
- Dyskinetic cerebral palsy and hemiplegic cerebral palsy.
- Huntington disease, but watch out! Keppra has caused dyskinesias in people with Huntington’s.
Figure it out? The magic word: refractory. Keppra is the go-to drug when nothing else will work, or whatever you take barely works.
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.
When/Why You Should Take Keppra (levetiracetam)
- Your neurologist said so.
- You have brain cancer.
- Your liver is next to useless.
- All the usual meds failed or barely work.
- You get more happy-happy joy-joy manic than scary psychotic manic
- And you tend to get manic far more often, and to a much greater extent, than depressed.
- Believe it or not, that is a real. nasty. problem.
- That’s the sort of bipolar people who aren’t bipolar or familiar with bipolar disorder want to be. I’ll trade them mine and my wrecked marriage for something nice and stable in their life anytime.
When/Why You Should NOT Take Keppra (levetiracetam)
- 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 may be your last best chance at treating an obscure or treatment-resistant condition.
Less Common/Experimental Off-Label Uses of Keppra
- Keppra has been successfully used for Landau-Kleffner syndrome.
- Keppra is OK for Unverricht-Lundborg disease.
- Eyelid myoclonia with absences (Jeavons syndrome). While the data are mixed with this one, when you’ve got an obscure and difficult-to-treat condition, anything that works for somebody is probably worth trying.
- Angelman syndrome. Including when the kid goes into nonconvulsive status epilepticus.
- premenstrual dysphoric disorder (PMDD). Although this is where an abstract is nowhere near enough data. Sure, it worked great for 6 out of 7 women, but what about the other 116 who were screened out of the study in the first place?
- Stiff person syndrome.
- Mad Cow Disease! Really. To control the myoclonic seizures associated with Creutzfeldt-Jakob. Here it is again, although that one is just bitching about vomiting. Neither has an abstract.
- Fragile X-associated tremor/ataxia syndrome. This is a problem carriers of Fragile X syndrome have, not the people with it.
- Hemifacial spasm.
Medicine Is The Best Medicine
Vaccines Cause Immunity
Mental Illness is NOT Contagious
Medicated For Your Protection
Be careful! Some off-label uses have been total fails, and otherwise safe meds can be downright dangerous when used for some things.
You probably want to avoid using Keppra for the following:
Failed Off-Label Uses
Alas, Keppra doesn’t work for absolutely everything. There are some things it can’t deal with.
- Essential tremor - You know it’s an epic fail when they pull the plug on a study after it did absolutely jack shit for 15 out of a planned 45 people, before they could find the remaining 30. The results from this study are only slightly less bad, but in Spanish.
- Chronic daily headache
- spinal cord injury pain
- The data are mixed with autism. It didn’t help with anything this study was looking at, and only some of the things this study was looking at.
- Behavioral and cognitive side effects from prednisone therapy. Hulk still smash. And from personal experience - Keppra doesn’t do squat to counter any of these types of side effects from steroid therapy or similar symptoms from the condition it’s treating.
- Postmastectomy pain syndrome. Keppra is great for brain cancer, but absolutely worthless for boob cancer.
- Charles Bonnet syndrome. Stick with Tegretol or Depakote, a Keppra just makes it worse.
Potentially Dangerous Off-Label Uses
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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, and my highly-skilled Google-fu, 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.
2 "Idiopathic" is doctorese for: The odds are you were born with it, but the symptoms didn't pop up until recently, so your doctor isn't 100% sure about what's causing the problem, but somehow it's your fault.
3 See the footnote above.
If you have any questions not answered here, please see the Crazymeds Keppra discussion board. We welcome criticisms of the articles, notifications of bad links, site problems, consumer experiences with medications, etc. I’m not always able to write back. Hence I never answer questions about meds via e-mail that are answered by this or other articles. Especially if they have been repeatedly asked on the forum. That’s why we write these damn things. Questions about which meds are best for your condition should also be asked on the forum; because this is a free site, so the price of admission is making things easier for somebody else searching for the same answer. We don’t deal with children on the forum or in private because after doing this for ten years I don’t have the emotional stamina to deal with kids who have brain cooties. How to contact Crazymeds. — Jerod Poore, CME, Publisher Crazymeds (crazymeds.net)
|Last modified on Sunday, 20 April, 2014 at 14:15:49 by JerodPoore||Page Authors , Jerod Poore||Date created Tuesday, 04 October 2011 at 11:12:28|
|“Keppra (levetiracetam): a Review for the Educated Consumer” by is copyright © 2011||Published online 2011/10/04|
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Almost all of the material on this site is by Jerod Poore and is copyright © 2003, 2004, 2005, 2006, 2007, 2008, 2009, 2010, 2011, 2012, 2013, 2014, and 2015 Jerod Poore. Except, of course, the PI sheets - those are the property of the drug companies who developed the drugs the sheets are about - and any documents that are written by other people which may be posted to this site will remain the property of the original authors. You cannot reproduce this page or any other material on this site outside of the boundaries of fair use copying without the express permission of the copyright holder. That’s usually me, so just ask first. That means if want to print out a few pages to take to your doctor, therapist, counselor, support group, non-understanding family members or something like that - then that’s OK to just do. Go for it! Please. As long as you include this copyright notice and something along the lines of following disclaimer, I’m usually cool with it.
All rights reserved. No warranty is expressed or implied in this information. Consult one or more doctors and/or pharmacists before taking, or changing how you take any neurological and/or psychiatric medication. Your mileage may vary. What happened to us won’t necessarily happen to you. If you still have questions about a medication or condition that were not answered on any of the pages you read, please ask them on Crazy Talk: the Crazymeds Forum.
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Nobody on this site is a doctor, a therapist, or a pharmacist. We don’t portray them either here or on TV. Only doctors can diagnose and treat an illness. While it’s not as bad as it used to be, some doctors still get pissed off by patients who know too much about medications, so tread lightly when and where appropriate. Diagnosing yourself from a website is like defending yourself in court, you suddenly have a fool for a doctor. Don’t be a cyberchondriac, thinking you have every disease you see a website about, or that you’ll get every side effect from every medication1. Self-prescribing is as dangerous as buying meds from fraudulent online pharmacies that promise you medications without prescriptions.
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Crazymeds is not responsible for the content of sites we provide links to. We like them, or they’re paid advertisements, or they’re something else we think you should read to help you make an informed decision about a particular med. Sometimes they’re more than one of those things. But what’s on those sites is their business, not ours.
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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 Remember kids, Microsloth operating systems are like TOS Star Trek movies with in that every other one sucks way, way more. With TOS Star Trek movies you don’t want to bother watching the odd-numbered ones. With Microsloth OS you don’t want to buy and install the even-numbered ones. Anyone who remembers ME and Vista knows what I mean.
3 Have I mentioned how open source operating systems for commercial applications is one of the dumbest ideas in the history of dumb ideas?* I don’t even need my big-ass rant any more. Heartbleed has made my case for me. And that’s just the one that got all the media attention. The very nature of an open source operating system makes security as much of an illusion as anonymity on teh Intergoogles. Before you flip out too much: the domain Crazymeds is hosted on uses a version of SSL that is not affected by the Heartbleed bug. That’s one of the many reasons why I pay a lot of money and keep this site on Lunarpages.
* Yes, I know I’m using open source browsers. I also test the site using the now-defunct IE and Safari browsers. Their popularity - and superiority - killed IE and Safari, so that’s why I rely on the open source browsers. It’s like brand vs. generic meds. Sometimes the generic is better than the brand.