> What Lamictal is Known For

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Side Effects | Lamictal Index | Consumer Reviews & Comments
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Why Don’t They Just Make Planes out of Black Boxes?

This is the stuff you actually need to be concerned about if you are currently taking, or considering taking, a medication. The black box 1 and other warnings are side effects that can be especially hazardous, if not fatal. These are often, but not always, what a med is most notorious for, e.g. The Lamictal Rash is a black box warning.

If a drug has a black box warning then a verbatim copy of it from its full US PI sheet will be here. We may comment on any black box warning. E.g. Translate doctorese, note just how rare the problem is, or how the warning is the result of the nexus of panic and politics. Any other warnings of note, the pregnancy category, and comments about them, will go here as well. As with Lamictal’s side effects, if you want to see them all, you’ll need to read the PI sheet. If you want to be paranoid pharmacophobic thorough, check Summary of Product Characteristics (SPCs) or other PI-equivalents we’ve found from other countries on the page of allegedly useful links. The US PI sheets have all the warnings you need to be actually concerned about, but once in awhile one will show up in some commie country on an overseas SPC before a PI sheet.

Black Box Warnings


LAMICTALTM can cause serious rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.8% (8 per 1,000) in pediatric patients (2 to 16 years of age) receiving LAMICTAL as adjunctive therapy for epilepsy and 0.3% (3 per 1,000) in adults on adjunctive therapy for epilepsy. In clinical trials of bipolar and other mood disorders, the rate of serious rash was 0.08% (0.8 per 1,000) in adult patients receiving LAMICTAL as initial monotherapy and 0.13% (1.3 per 1,000) in adult patients receiving LAMICTAL as adjunctive therapy. In a prospectively followed cohort of 1,983 pediatric patients (2 to 16 years of age) with epilepsy taking adjunctive LAMICTAL, there was 1 rash-related death. In worldwide postmarketing experience, rare cases of toxic epidermal necrolysis and/or rash-related death have been reported in adult and pediatric patients, but their numbers are too few to permit a precise estimate of the rate.

Other than age, there are as yet no factors identified that are known to predict the risk of occurrence or the severity of rash caused by LAMICTAL. There are suggestions, yet to be proven, that the risk of rash may also be increased by (1) coadministration of LAMICTAL with valproate (includes valproic acid and divalproex sodium), (2) exceeding the recommended initial dose of LAMICTAL, or (3) exceeding the recommended dose escalation for LAMICTAL. However, cases have occurred in the absence of these factors.

Nearly all cases of life-threatening rashes caused by LAMICTAL have occurred within 2 to 8 weeks of treatment initiation. However, isolated cases have occurred after prolonged treatment (e.g., 6 months). Accordingly, duration of therapy cannot be relied upon as means to predict the potential risk heralded by the first appearance of a rash.

Although benign rashes are also caused by LAMICTAL, it is not possible to predict reliably which rashes will prove to be serious or life threatening. Accordingly, LAMICTAL should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug related. Discontinuation of treatment may not prevent a rash from becoming life threatening or permanently disabling or disfiguring.

Black Box Comments

Let’s read this part of the black box warning from the the PI sheet again:

LAMICTAL should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug related.

IF the rash doesn’t meet the itchy and fever criteria, AND IF you can find the source of a new or potentially irritating substance that didn’t previously bother you, then maybe you can chalk it up to contact dermatitis - an allergic reaction caused by touching or otherwise coming into contact with something your skin doesn’t like - and a common Lamictal side effect.

If you and your doctor think Lamictal is worth the bother of continuing, talk it over. The last paragraph in the black box warning is clear as mud. Translated from corporate lawyer weasel speak:

“Most rashes are no big deal, but you can never tell. So if you think you might be developing anything that may be a rash, stop taking Lamictal immediately. Because even if you quit taking Lamictal immediately that won’t necessarily prevent the rash from killing you or making you look like Edward James Olmos’ and Amy Winehouse’s love child.”

To make things easier for you, here is a picture of Lamictal-induced Stevens-Johnson Syndrome (SJS). AKA The Lamictal Rash:

The Lamictal Rash
Image from health-pictures.com

Lamictal (lamotrigine) Other Warnings & Things to Worry About

For all warnings, contraindications, etc., see the Lamictal (lamotrigine) PI sheet.

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Lamictal (lamotrigine) Pregnancy Category

C-Use with caution

Pregnancy Category Comments

Lamictal (lamotrigine) is one of the safest crazy meds to use with a C grade. There were some problems in the animal tests, but those could have been due to a single factor: not enough folate. As Lamictal was originally designed to be a folate antagonist that makes a surprising amount of sense. You should know all about taking folic acid when pregnant.

In fact, it’s the mothers who are more at risk when pregnant than the babies. Just as estrogen-based birth control can affect Lamictal, so can getting pregnant. You may need to increase your dosage. Breastfeeding may not be an option - unless you’ve got a wet nurse handy - especially if you had to raise your dosage while pregnant. As always talk to both of your doctors. My opinion: some of mom’s milk should usually be used in order to help wean the kid off of whatever meds she had to take while pregnant.

What Do the Pregnancy Categories Mean?

Pregnancy categories A, B, C, D, and X are used to quantify both risk and the risk-to-benefit ratio. They are relatively neutral when it comes to severity of birth defects.

The only difference between categories A and B is that the drug companies conducted human trials to get that A rating, while the B rating means there has been no reported birth defect of any kind since the drug has been on the market. With both A and B, no matter how much of either med researchers give to critters, their cute little babies are just fine. Until dissected to prove there is no problem.

Category X is fairly straight-forward. You take this drug while pregnant, possibly pregnant, or potentially pregnant, your kid will be born with three arms and a total of two fingers. There are also plenty of alternatives available. So unless you’ve tried absolutely everything else already, and you insist on damning some innocent child to the same brain cooties that you have, talk to your doctor about another med.

It’s the meds that are categories C and D are difficult. C means animals gave birth to mutants when given anywhere from sub-therapeutic to ridiculously high amounts of the medication in question, and there have been reports of human birth defects that may be to probably are2 due to taking the med. Sometimes the data from the field are so vague (e.g. all or almost all the women were taking at least one other medication), and the critters didn’t spawn Roger Cormanesque offspring on anything lower than 50 times the maximum human dosage, that it’s pushing a C+ to B-. The important thing is category C meds are first-line drugs while category D meds are often, but not always, second- or third-line drugs.

For more information, see the Federal Regulations covering PI sheets and the FDA’s Summary of Proposed Rule on Pregnancy and Lactation Labeling. They’re both remarkably clear for legal / bureaucratic documents. Doubly so considering the FDA published them.

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Drug-Drug, Drug-Supplement, Drug-Food Interactions

Most drug-whatever interactions involve elimination metabolism. With crazy meds the best known example is Lamictal and Depakote or whichever flavor of carbamazepine you’re taking. If you’re taking Depakote you need to take less Lamictal less often. With Tegretol or Equetro you need to take more Lamictal more often. That’s not always the case. Interactions can affect transformation, which is why Paxil + tamoxifen = that breast cancer isn’t going anywhere, because tamoxifen itself doesn’t do shit, your liver turns it into endoxifen (and perhaps others), which does all the dirty work. Interactions can also be potentiations, where one drug enhances the effect of another without slowing its clearance. All patient information leaflets and drug-drug interaction checkers have boilerplate potentiation interactions along the lines of, “two or more antidepressants meds can make you extra drowsy/spacey/ready to go on a tri-state multicide spree.” Alcohol potentiates the sedative effects of TCAs, while alcohol and benzodiazepines potentiate each other3. There can be interactions that are beneficial, and those rarely show up in PI sheets or drug-drug interaction checkers.

Noted Drug-Whatever Interactions

  • Rooibos (Aspalathus linearis)/ red tea may be a potent inducer of UGTs. As such you should probably avoid Rooibos/red tea/whatever it’s called where you live if you’re taking Lamictal.
  • Like many crazy meds, especially AEDs, you may need to take more Lamictal and/or take it more often if you smoke.
  • I cannot stress often enough the interaction between Lamictal and anything containing ethinyl estradiol, which is practically every form of pharmacological birth control except the Depo-Provera (medroxyprogesterone) injection.
  • Lamictal’s bioavailability may be affected by food. That’s the only study I’ve found showing any affect food has had on Lamictal, but this med is so screwy it wouldn’t surprise me if it can make enough of a difference for some people.
  • Like most AEDs, Lamictal messes with how your body deals with folate. So you’ll probably need to take a folic acid supplement.
  • Your doctor and pharmacist should have at least mentioned Lamictal’s interactions with Tegretol/Equetro (carbamazepine) and the valproates: Depakote, valproic acid, Stavzor, and commie Depakote sodium valproate / valproate sodium. There are even more interactions involved. So, if you have multiple brain cooties or your doctor hasn’t quite pinned down what the hell is wrong with you:
    • Lamictal + carbamazapine could be a bad idea.
    • Lamictal + Trileptal (oxcarbazepine) could be an even worse idea.
    • While Lamictal + Depakote can be a really good idea if either med by itself isn’t working well enough to control your seizures.
    • And Lamictal + Topamax can be a good idea, but only if you take around the same amount of each and you aren’t taking high dosages of either.
  • What’s the deal with the above? It’s in how the meds work, specifically with sodium channels. Too much and you don’t just get stupid, you may as well not be taking an AED. But if the drugs compliment each other, then your brain will be a lot happier.
  • Lamictal is notorious for causing multiday hangovers if you drink the least amount of alcohol.
    • Drinking while taking AEDs isn’t that great an idea, but unless you enjoy waking up with an epic hangover, don’t even drink half a lite beer if you’re taking Lamictal.

Check for Drug-Drug-Drug Interactions

Drugs.com’s drug-drug and drug-food interaction checker

It’s always a good idea to check for drug-drug interactions yourself. Just because most people in the crazy meds business know about really important interactions (e.g. MAOIs and a lot of stuff, warfarin and everything on the planet) doesn’t mean the person who prescribed your meds told you about them, or the pharmacist has all the meds you take at their fingertips like they’re supposed to. Or they have the time to do their jobs properly when not dealing with complete idiots or playing Angry Farmers on the Faecesbooks.

Side Effects | Lamictal Index | Consumer Reviews & Comments
Return to the Lamictal Page

1 Called "black box warnings" because they appear in a box at the top of the PI sheets, written in big, bold print, and originally surrounded by a thick, black outline. Some companies still put black box warnings in a black box. There is no relationship to the black boxes in airplanes, although I haven't tried burning a number of different PI sheets to see if the black box warnings are still legible in the ashes.

2 Don't expect the drug companies to always cooperate in figuring out where on that scale their meds are.

3 Or: Alcohol + TCAs = Die like a 1960s trophy wife. Alcohol + Benzos = Die like a rock star.

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.us)

Last modified on Sunday, 17 April, 2016 at 18:58:03 by JerodPoorePage Author Date created April 05, 2011, at 15:24:23
“Lamictal (lamotrigine): a Review for the Educated Consumer.” by Jerod Poore is copyright © 2011 Jerod Poore Published online 2011/01/18
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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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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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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.

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