approved indications and clinically-significant off-label uses, as well as experimental and failed applications
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.
Lamictal is US FDA-Approved to Treat:
Lamictal has some of the most complicated approvals of all crazy meds.
Approved in June 2003 for the maintenance treatment of bipolar 1. Here it is the current approval from the PI sheet:
LAMICTAL is indicated for the maintenance treatment of Bipolar I Disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in adults (≥18 years of age) treated for acute mood episodes with standard therapy
The emphasis is mine. Officially you must not be showing any symptoms of bipolar disorder, either because you’re taking another drug or you’re in a period of remission you know will be short-term, before you start taking Lamictal. If you’re symptoms aren’t under control, especially if you’re not taking another med, you’re technically using Lamictal off-label.
I cannot stress how much I agree with the FDA on this one. Lamictal is a very effective maintenance med - a drug you plan on taking for a very long time to keep your symptoms under control - with a very low side-effect profile. As a drug to stop your symptoms it’s OK.
First approved for epilepsy
Adjunctive Therapy: LAMICTAL is indicated as adjunctive therapy for the following seizure types in patients ≥2 years of age:
- partial seizures
- primary generalized tonic-clonic seizures
- generalized seizures of Lennox-Gastaut syndrome
It’s when you want to take Lamictal by itself that things get really complicated:
Monotherapy: LAMICTAL is indicated for conversion to monotherapy in adults (≥16 years of age) with partial seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED)
Safety and effectiveness of LAMICTAL have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs. --ibid
As with bipolar disorder, the FDA says you can take Lamictal by itself only if you’re already taking another drug that you want to stop taking. Unlike bipolar disorder, officially you can switch to Lamictal only if you’re taking the drugs they list, otherwise it’s an off-label use.
As with bipolar, I totally agree with the FDA. You either want to add Lamictal to whatever you’re currently taking to help it work better, or to switch to it because Lamictal sucks less than most other meds.
Lamictal (lamotrigine) is Approved Elsewhere for:
Clinically Significant or Otherwise Common Off-Label Uses of Lamictal (lamotrigine)
- Bipolar 2
- Best treatment, hands down, according to Stahl and all the evidence I’ve gathered.
- Then again - maybe not.
- Initial therapy for bipolar disorder.
- Various forms of treatment-resistant bipolar disorder
- Treatment-resistant depression / misdiagnosed bipolar 2.
- Initial monotherapy for partial seizures, or converting from a drug not listed in the PI sheet.
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 Lamictal (lamotrigine)
- You have bipolar 2.
- You’re epileptic, or have something else commonly treated with AEDs, and want to get pregnant.
- Your symptoms are under control, but whatever you’re now taking really sucks.
When/Why You Should NOT Take Lamictal (lamotrigine)
- You’re bipolar and tend to run mainly manic.
- Especially right now, or whenever you’re considering starting Lamictal.
- Extra-especially if it’s a dysphoric mania, or you have dysphoric manias (you’re angry, anxious, and/or irritable instead of happy and productive along with not wanting to sleep, talking too fast and all the time, and all the other symptoms of mania you usually get).
- You have a history of skin problems.
- Unless you’re sure you and your doctor can tell the difference between all the skin problems you’ve had that might come back, and be worse, and something that is potentially a real problem.
- But if you have a history of skin problems like SJS and TEN you shouldn’t even be reading about Lamictal.
- Your symptoms aren’t under control.
- Whether or not you’re taking any meds to control them.
- Because Lamictal is for transitioning to NOT starting with!
When all else fails and you’ve run out of other options, Lamictal may be your last best chance at treating an obscure or treatment-resistant condition.
Less Common/Experimental Off-Label Uses of Lamictal
- Autosomal dominant nocturnal frontal lobe epilepsy.
- SUNCT syndrome headaches.
- Dealing with Keppra’s psychiatric side effects.
- Stroke-related applications, including:
- Preventing post-stroke seizures
- Pathological laughing and crying/pseudobulbar affect/(PBA)/emotional lability/emotional incontinence
- Stroke-related pain
- Preventing more strokes, although the data are contradictory. First the method of action is unclear.
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 Lamictal for the following:
Failed Off-Label Uses
Potentially Dangerous Off-Label Uses
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Stahl’s Essential Psychopharmacology: Neuroscientific Basis and Practical Applications (Essential Psychopharmacology Series) Third edition by Stephen M. Stahl © 2008 ISBN:978–0521673761 Published by Cambridge University Press.
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.
If you have any questions not answered here, please see the Crazymeds Lamictal 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 Monday, 04 May, 2015 at 14:48:14 by JerodPoore||Page Author Jerod Poore||Date created|
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Lamictal, and all other drug names on this page and used throughout the site, are a trademark of someone else. Lamictal’s PI Sheet will probably have the name of the manufacturer and trademark owner (they’re not always the same company) at or near the very bottom. Or ask Google who the owner is. The way pharmaceutical companies buy each other and swap products like Monopoly™ real estate, the ownership of the trademark may have changed without my noticing. It may of changed hands by the time you finished reading this article.
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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.
The information on Crazymeds pertains to and is intended for adults. While some information about children and adolescents is occasionally presented (e.g. US FDA approvals), pediatric-specific data such as dosages, side effects, off-label applications, etc. are rarely included in the articles on drugs or discussed on the forum. If you are looking for information regarding meds for children you’ll have to go somewhere else. Plus we are big pottymouths and talk about S-E-X a lot.
Know your sources!
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.
All information on this site has been obtained from the medications’ product information / summary of product characteristic (PI/SPC) sheets and/or medication guides - which is all you get from sites like WebMD, RxList,
NAMBLA NAMI, etc., the sources that are referenced throughout the site, our personal experience and the experiences family, friends, and what people have reported on various reputable sites all over teh intergoogles. As such the information presented here is not intended as a substitute for real medical advice from your real doctor, just a compliment to it. You should never, ever, replace what a real doctor tells you with something from a website on the Internet. The farthest you should ever take it is getting a second opinion from another real doctor. Educate yourself - always read the PI/SPC sheet or medication guide/patient information leaflet (PIL) that comes with your medications and never ever throw them away. OK, you can throw away duplicate copies, but keep at least one, as that’s your proof of purchase of having taken a med in case a doctor doubts your medical history. Plus they take up less space than a bottle, although keeping one inside of a pill bottle is even better.
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.
Crazymeds is optimized for ridiculously large screens and browsers that don’t block ads. I use Firefox and Chrome, running under Windows 72. On a computer that sits on top of my desk. With a 23 inch monitor. Hey, at least you can make the text larger or smaller by clicking on the + or - buttons in the upper right hand corner. If you have Java enabled. Like 99% of the websites on the planet, Crazymeds is hosted on domain running an open source operating system with a variety of open source applications, including the software used to display what you’ve been reading. As such Crazymeds is not responsible for whatever weird shit your browser does or does not do when you read this site3.
No neurologists, psychiatrists, therapists or pharmacists were harmed in the production of this website. Use only as directed. Void where prohibited. Contains nuts. Certain restrictions may apply. All data are subject to availability. Not available on all mobile devices, in the 12 Galaxies Guiltied to a Zegnatronic Rocket Society, or in all dimensions of reality. Hail Xenu!
‘Everything is true, nothing is permitted.’ - Jerod Poore
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.