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FDA adds suicide warning to epilepsy drugs

The Associated Press
   3:37 PM EST, December 16, 2008
        "...The new warnings apply to 21 medications, including blockbuster products like GlaxoSmithKline's Lamictal, Johnson & Johnson's Topamax and Pfizer's Lyrica."

I just found this on another site.  In case anyone on Topamax hasn't heard.  :-/

When you read warnings like this, it's critical to note the dosing and patient population to which it applies. For this broad class of meds, problems arise in populations using high doses continously. May or may not apply to CH folks.

We have seen the same picture re. Zyprexa (olanzapine) but no evidence that it affects the CH user who uses low doses for short periods.

Always look for time/dosing information before making any judgments!

As Bob mentions, "this may or may not apply to CH folk" so it's important anyone using a medication has all the information to hand and can make an informed decision for themselves.

That's why posts such as yours are important, UtR. Good onya.

UtR..just read the FDA;s warning regarding Topamax. I was put on it by my Neuro a couple of years ago.
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Being from Canada I'm going to look into what Health Canada has to say on the matter. That is not to say I don't believe the FDA.

I'm presently in treatment trying to cope with the suicides of my two brothers.This info strikes me close to home.

Thanks for bringing it to light. Iddy

"ROCKVILLE, Maryland -- The US Food and Drug Administration has announced today that it will require the manufacturers of antiepileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviours. The action includes all antiepileptic drugs including those used to treat psychiatric disorders, migraine headaches, and other conditions, as well as epilepsy.

"The FDA's actions are based on the agency's review of 199 clinical trials of 11 antiepileptic drugs which showed that patients receiving antiepileptic drugs had almost twice the risk of suicidal behaviour or thoughts (0.43%) compared with patients receiving a placebo (0.24%). This difference was about 1 additional case of suicidal thoughts or behaviours for every 500 patients treated with antiepileptic drugs instead of placebo. Of the patients who were randomised to receive one of the antiepileptic drugs, 4 committed suicide, whereas none of the patients in the placebo group did. Results were insufficient for any conclusion to be drawn about the drugs' effects on completed suicides. The biological reasons for the increase in the risk for suicidal thoughts and behavior observed in patients being treated with antiepileptic drugs are unknown.

"The following antiepileptic drugs are required to add warnings about the risk of suicidality: carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol XR); clonazepam (Klonopin); clorazepate (Tranxene); divalproex sodium (Depakote, Depakote ER, Depakene); ethosuximide (Zarontin); ethotoin (Peganone); felbamate (Felbatol); gabapentin (Neurontin); lamotrigine (Lamictal); lacosamide (Vimpat); levetiracetam (Keppra); mephenytoin (Mesantoin); methosuximide (Celontin); oxcarbazepine (Trileptal); phenytoin (Dilantin Suspension); pregabalin (Lyrica); primidone (Mysoline); tiagabine (Gabitril); topiramate (Topamax); trimethadione (Tridione); and zonisamide (Zonegran). Some of these medications are also available as generics."

How ironic that CH is sometimes referred to as Suicide Headache. Take the Topamax to prevent you from wanting to kill yourself from the pain and wind up killing yourself because of the medication. I was under the belief that Topamax was a mood stabilizer.

AussieBrian wrote on Dec 26^th, 2008 at 9:56am:

As Bob mentions, "this may or may not apply to CH folk" so it's important anyone using a medication has all the information to hand and can make an informed decision for themselves. That's why posts such as yours are important, UtR. Good onya.

With all the warnings coming out about just this type of "side effect" from more and more medications, not only is it important to make informed decisions, but please, if you are taking any of these meds, or the growing list of anti-depressants with the same side effect, keep track of how you are feeling when taking them. It's easy to start to sink into a depression, and think it has something to do with your CH, or something else in your life, when it could very well be the medication making you feel this way.

Be sure to let your doctor know right away if you notice any changes in how you feel.

Thanks, UtR, for posting the link.

Well, I take FDA "warnings" with a grain of salt, but I found this on a migraine message board, and at LEAST a dozen of those folks wrote in to say that yes, they had gotten seriously suicidal within days of starting these drugs (and I believe they were on pretty low doses, too, for migraines.)

I know from dealing with anxiety and depression and ADHD for many years that you never can tell how an individual may react to the "neurological" kind of meds...even with very closely-related drugs (like the amphetamine-based ADD meds, for example) I get a noticeably different effect just from different brands with maybe a slightly altered molecular structure.

And right-on, Purpleydog, keep track of your moods as well as your pain, and tell your doctor about any changes; the trickiest part of depression is that it's your own brain telling you you are depressed, so you may not even think anything is medically wrong because you feel emotionally wrong!  :D

Yes, Webgopher, the irony is palpable...what a bitch, huh?  The LAST thing we need for suicide headaches is to get more suicidal!!  :o  Be careful, y'all.

-Paige

Hey Paige, the only drug that made me seriously suicidal was Effexor. I was within inches of offing myself on that crap… I had the gun loaded, and I had put a sign on the basement door stating call 911 and do not enter without the cornier! The days before HF O2 were really BAD!!!

Note to all feeling this way; when you do as I did and start filling out a DNRO, its time to call the suicide hotline!!! I found this place and that day ended unevenfully thank GOD, and the suicide link on this SITE!!!

Roland. :-X

Okay, this is just from personal experience but...

Most anti-depressants have this same warning.

The reason behind it? Because, everyone has different body chemistry.

What may fix your depression, may make someone else worse, or consider commiting suicide. I've gone through it with some anti-depressants, along with plenty of other people I know.

They kind of have to warn you, or else, they are liable. I'd suggest if you have CH and ANY kind of mental illness along with it, you be careful when put on anything new. Any weird or suicidal thoughts = call your doctor, call a suicide hotline, or head to the ER. Depending on the severity of the situation.

It may seem like common sense, but if common sense ruled, there would be no need for warning labels put on a LOT of things.

ETA: Lamictal didn't make me suicidal. It made me laugh hysterically for hours off and on in between my throat closing up on me... >_>;;

Yeah, why do they call it "common" sense when it's anything but??!!  :D

I don't need no Topamax, goldurnit. I contemplate suicide regularly without it JUST FINE!