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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.  Topamax is US FDA-Approved to Treat:

Migraine2: Monotherapy (used by itself) for adults to prevent (prophylaxis) migraine headaches.

Epilepsy:

2.  Topamax (topiramate) is Approved Elsewhere for:

3.  Clinically Significant or Otherwise Common Off-Label Uses of Topamax (topiramate):

See the page on Topamax’s efficacy for details on the likelihood Topamax 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 Topamax

  • You have frequent migraines and/or seizures of the type your neurologist thinks would respond well to Topamax.
  • You’ve never taken a medication to treat epilepsy before.
    • Really. Topamax works best when it’s the first med you’ve taken. Hence the complicated approval.

5.  When/Why You Should NOT Take Topamax

You’re bipolar and you don’t want to take any other med because you’re afraid you’ll gain weight.

When all else fails and you’ve run out of other options, Topamax 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 Topamax

7.  Failed Off-Label Uses

8.  Potentially Dangerous Off-Label Uses

‹ Brand and Generic Availability | Topamax Index | How Long & How Likely To Work, Comparisons with Other Meds ›
Crazy Meds Comprehensive Topamax 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.

2 Johnson & Johnson / Ortho-McNeil-Janssen Pharmaceuticals consider migraine prophylaxis to be the primary indication for Topamax.

3 Although these days airport security is probably enough to make anyone's head explode. In any event, that's a somewhat graphic video. Don't say I didn't warn you.



Date created 31 Dec 1969 - 17:00 Page Creator: Jerod Last edited by: JerodPoore

Topamax Approved and Off-label Uses by Jerod is copyright 1969 Jerod


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Almost all of the material on this site is by Jerod Poore and is copyright © 2004, 2005, 2006, 2007, 2008, 2009, 2010, 2011, and 2012 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 the 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.
The information on Crazy Meds 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.
Know your sources!
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All information on this site has been obtained through our personal experience and the experiences family, friends, what people have reported on various reputable sites all over teh intergoogles, the medications’ product information / summary of product characteristic (PI/SPC) sheets, and from sources that are referenced throughout the site. 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 patient information leaflet (PIL) that comes with your medications and never ever throw them away.
Crazy Meds 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.
Very little information about visitors to this site is collected or saved. From time to time I look at search terms used and which pages they bring up in an effort to make the information I present more relevant. And the country of origin, just because I’m geeky like that. That’s about it. Depending on how you feel about Schrodinger, our privacy policy should either assuage or exacerbate your paranoia.
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Crazy Meds is optimized for the browser you’re not using on the platform you wish you had. Between you and me, it all looks a lot cleaner using Firefox or Safari, which is what a plurality of visitors use. And I’m running Windows XP3. 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, Crazy Meds 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 Crazy Meds is not responsible for whatever weird shit your browser does or does not do when you read this site2.
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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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