DG Alert: Antiepileptics Linked to Suicidal Behavior

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Yvonne
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DG Alert: Antiepileptics Linked to Suicidal Behavior

Postby Yvonne » Mon 11 Feb 2008 20:28

FDA Analysis Showed Patients Receiving Antiepileptic Drugs Had Approximately Twice The Risk of Suicidal Behavior Or Ideation

ROCKVILLE, MD -- January 31, 2008 -- FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA's analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.

Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.

The drugs included in the analyses include (some of these drugs are also available in generic form):

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Levetiracetam (marketed as Keppra)
Oxcarbazepine (marketed as Trileptal)
Pregabalin (marketed as Lyrica)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
Zonisamide (marketed as Zonegran)

Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly.

Read the complete 2008 MedWatch Safety Summary including a link to the Healthcare Professional Sheet regarding this issue at:

http://www.fda.gov/medwatch/safety/2008 ... iepileptic

http://www.docguide.com/news/content.ns ... E1007057A9
Listen to all,
plucking a feather from every passing goose,
but follow no one absolutely

minitails2
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Joined: Sat 3 Nov 2007 10:27

Re: DG Alert: Antiepileptics Linked to Suicidal Behavior

Postby minitails2 » Sun 17 Feb 2008 7:21

Yvonne,
Thank you for posting this, it's very interesting. At least one of these is used by some lyme patients for neuropathy issues.

http://www.fda.gov/medwatch/safety/2008 ... iepileptic

Data from 199 placebo-controlled clinical studies covering eleven different antiepileptic drugs were reviewed and analyzed for reports of suicidal behavior (completed suicides, suicide attempts and preparatory acts) and suicidal ideation. The studies examined the effectiveness of the drugs in epilepsy, psychiatric disorders (e.g., bipolar disorder, depression and anxiety) and other conditions (e.g., migraine and neuropathic pain syndromes). The analysis included a total of 43,892 patients ages five and older (27,863 in drug treatment groups and 16,029 in placebo groups).


I don't quite remember where, but I think that Cavey posted some information about some issues with this type of study. Anyone remember?

Also, I do find it slightly strange that there is no distinction between suicidal ideology and suicidal behavior. I'm sure this study must be available in its entirety somewhere. There's a huge difference.

The summary of the study did not say which group the 4 completed suicides were in.

Also important to note that any psych med that helps with depression (which many of these could be prescribed for) tends to increase the risk of suicide for some period of time.

I'll have to see what I can find and see if I can slog through a more comprehensive copy of the study, it's just hard with my attention deficit in full bloom right now. Complain, complain. :bonk:

cave76
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Re: DG Alert: Antiepileptics Linked to Suicidal Behavior

Postby cave76 » Sun 17 Feb 2008 17:30

****information about some issues with this type of study****

Do you mean the inherent flaws in a meta-analysis? I've posted that here and at Lymenet usa. Maybe I can find it, some day, some time.

The drugs I've listed below are the drugs prescribed to me in the early days of my TBIs.

Fortunately I always had a strong suspicion about drugs (got over it about abx. :)) and either took just one or just let them sit on the shelf and hope that osmosis would work from a distance.

Each one I got brave enough to sample was a disaster for me---- agitation galore. Since I never once believed doctors (even llmds) are gods---- I stopped taking them immediately.

There's a medical phenomenon out there called paradoxical reactions.

I had it. :)

Sleep meds, back then, keep me awake and agitated. Everything worked almost the opposite of what it was supposed to. Even herbs.

Neurontin

Lyrica

Gabitril

Topamax

(Ritalin)

(Others I can't remember)

kelmo
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Location: Valley of the Sun

Re: DG Alert: Antiepileptics Linked to Suicidal Behavior

Postby kelmo » Sun 17 Feb 2008 18:29

When my daughter daughter started with symptoms of this disease, she had migraines. Topamax was a lifesaver for her. After a couple of years, it stopped working for her. That may have been due to an increase in bacteria, that, at that time, was unknown to us.

After the migraines, came the psyche stuff...OCD, depression, anxiety, night terrors. She kept those hidden for a while. I don't believe those symptoms were caused by the Topamax.

In the waiting period for a good phsychiatrist, her PCP tried her on samples of anti-anxiety/depression medications. The worst one of all was Respiradol (sp?). She said that for the few days she was on that, she wasn't just suicidal, she was homocidal.

After seeing the last Lord of the Rings trilogy, she came home and had a breakdown. She said, that she could see herself turning into Gollum, and she didn't know how to stop it.

This was a very dark, very long period in my daughter's life. I had to stay with her at all times.

This was in the winter of 2004. Since then, she has really leveled out. She has improved on the combination of antibiotic treatment, cognitive therapy, and psyche meds that really work for her.

Now, when she has a low day, it's a low day just like everyone else. She has normal moods and emotions.
We are hoping as health returns to her that she will be able to back off on some of the medications. But, for right now, keeping brain chemicals balanced is aiding the healing process of the disease.

Any drug that has brain involvement is going to pose a risk of suicidal behavior. Heck, some antibiotics will do that---Mepron is one that caused problems for us.

What we need are doctors who are up front about the risks, monitor the patient, and make patients aware of this issue so they can watch for signs. Some doctors are afraid of the power of suggestion. When our PCP gave us samples of antidepressants for my daughter, he would just say he wanted to see her in a month. He never said to watch for signs of worsening behavior or thoughts.

Kelmo

cave76
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Joined: Sun 12 Aug 2007 2:27

Re: DG Alert: Antiepileptics Linked to Suicidal Behavior

Postby cave76 » Sun 17 Feb 2008 18:57

Kelmo

****.OCD, depression, anxiety, night terrors.****

Oh, I remember those years, for me! I can barely talk about them--- even though they've been gone for many years.

Until a person has had them---------- :(

The only left-over (other than brain damage :)) for me is a weird, obsessive behavior about my sleep. It's a LOT better, but the slightest change in my late evening pattern can cause me to not be able to go to sleep. And when I finally do--- the rest of the night is 'disturbed' sleep, light sleep.

It's SO much better---- for it used to be almost any time after 5 p.m. was a delicate time for me and my sleep. :( A phone call after 6 or 7 p.m. would almost guarantee no sleep for me. Or any other innocuous happening like that.

But after I found Ambien and discovered that it was a good sleep med for me, I'd keep the Ambien at bed side as a fail-safe placebo. So, if my evening had been 'disturbed' I could go to bed knowing that Ambien was there IF I needed it. (Who says placebos don't work???) :)

Still keep Ambien there---- to help if I need it.

After years and years of a very strict adherence to my OCD around sleep----- it's mostly gone. But still lingers just to remind me----- watch out! Don't mess with me. :(

Sorry this was so long. But when I can talk about it, every time I can whistle past the graveyard, it helps. :(

Do--- kelmo----- your poor daughter! Tell her I know exactly what she went through. Thank goodness I wasn't a teen or adolescent (with all the attendant growing-up stuff) when this happened. :(

And if a person has never had the night terrors---- that last for years----- count your blessings.

kelmo
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Location: Valley of the Sun

Re: DG Alert: Antiepileptics Linked to Suicidal Behavior

Postby kelmo » Sun 17 Feb 2008 19:04

I'm so glad you told your story. I know so little about your Lyme journey.

One time, during the migraine period, the PCP gave her a sample of Imitrex nasal spray. It burned like FIRE for hours.

That night, she had her usual night terror of knives and scissors, and her body being sliced up. When she woke in the middle of the night, she was covered in blood.

She figured out it was a bloody nose from that Imitrex spray.

minitails2
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Joined: Sat 3 Nov 2007 10:27

Re: DG Alert: Antiepileptics Linked to Suicidal Behavior

Postby minitails2 » Tue 19 Feb 2008 12:41

Kelmo,
Your wrote:

her PCP tried her on samples of anti-anxiety/depression medications. The worst one of all was Rispiradol (sp?).


That is a strong antidepressant to for a PCP to try on a patient. That should really be a psychiatrist only sort of drug. I'm sure you know, but just some everyone does, that drug is not in the class mentioned at the top which are antiepilectics or as they're commonly referred to as anti-seizure drugs.

minitails2
Posts: 1001
Joined: Sat 3 Nov 2007 10:27

Re: DG Alert: Antiepileptics Linked to Suicidal Behavior

Postby minitails2 » Tue 19 Feb 2008 12:59

Cavey,

You wrote:
Sleep meds, back then, keep me awake and agitated. Everything worked almost the opposite of what it was supposed to. Even herbs.


That's known as flipping. I've had that problem a lot with certain types of medications. Supposed to make you sleepy? No! Agitation. Actually, some medications list possible side effects along with their opposite just because there is a subset of people who had opposite reactions. Such as: May cause weight loss, may cause weight gain, may cause agitation, may cause sleepiness and so on.

It's a good thing to watch out for.

(I also always get the side effect no one's ever heard of and is always in the last paragraph of the PDR affecting - almost without fail-.5% of the study participants. I've provided a good education for my doctors.) :ugeek:

itsy
Posts: 786
Joined: Mon 29 Oct 2007 21:03

Re: DG Alert: Antiepileptics Linked to Suicidal Behavior

Postby itsy » Tue 19 Feb 2008 18:16

Cavey...

We have the same syndrome I think. Sudafed makes me sleepy. Gabapentin gives me tremors...or shall I say, makes my tremor worse. Lyrica gives me anxiety. Antidepressants, in low dose for pain, make me depressed, to the point of despair. Atavan made me anxious...like pulling my hair out, jump out of my skin anxious.

The only thing I have ever taken that has done what it said it should do was Xanax. That did make me sleep better.

That being said, MOSt (not all but most) of my sleep disorder stuff has been much better this year since being on antibiotics. I rarely ever have sleep troubles anymore, and the sleep I get is better. AND...the sleep paralysis, I haven't had that in months. MONTHS! Most narcoleptics have that for the rest of their lives. ABX pretty much cured mine.

Cobwebby
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Joined: Mon 29 Oct 2007 0:55

Re: DG Alert: Antiepileptics Linked to Suicidal Behavior

Postby Cobwebby » Sun 2 Mar 2008 15:37

Glad I saw this- I almost forgot to take my Keppra this morning.

My neurologist calls me an "exquisite responder"- meaning a little goes a long way.

Of course- I have been aware of this for a while-which means when a doc prescribes full dose(for whatever)-I have it filled, then cut my intake in half- and stockpile the rest in case I ever want to off myself.
The greater part of our happiness or misery
depends on our dispositions,
and not on our circumstances.
Martha Washington


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