Suicide Risk From 11 Epilepsy Drugs

[speber]

I received this in an email and thought I should share with you all since I've seen threads recently touching on the subject of Trileptal and its effects on you:

The FDA today notified healthcare professionals that a range of
anti-epileptic products, including TRILEPTAL, were associated
with a significantly higher risk of suicidal thoughts and
behavior (0.43% vs 0.23%) than placebo in clinical trials. This
increased risk was observed as early as one week after starting
the antiepileptic drug and continued through 24 weeks. These
results were consistent amongst the eleven drugs studied, and
the FDA believes that this risk is likely to be shared by all
antiepileptic medications.

For more information, please visit:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic


* * * *
WHAT DOES THIS MEAN?

Although the risk of suicidal thoughts and behavior appears to
be almost double that of placebo, its frequency remains lower
than 1 in 200 - and, and this stage, is unlikely to affect the
iGuard risk rating for TRILEPTAL in otherwise healthy patients.


Since most conditions treated with antiepileptic products are
serious in nature, this communication is likely to help doctors
and patients watch more closely for suicidal thoughts behavior,
especially in patients just starting treatment, but - in most
cases - is unlikely to result in changes in treatment. That
said, if you are taking any antiepileptic products and have any
suicidal thoughts, contact your doctor immediately.

...and I thought it was just me feeling 'off'........whew!

 

[forward2007]

That sounds scary.

 

[speber]

No kidding...

...some folks have REAL trouble with the stuff!
I haven't had much trouble myself but I thought I should pass it along.
onder:

 

[speber]

Suicide Risk From 11 Epilepsy Drugs - From WebMD 01/31/08

Okay, now this is getting almost funny...
check this out (which DOES NOT READ FUNNY AT ALL)...

The FDA today notified healthcare professionals that a range of
anti-epileptic products, including ZONISAMIDE, were associated
with a significantly higher risk of suicidal thoughts and
behavior (0.43% vs 0.23%) than placebo in clinical trials. This
increased risk was observed as early as one week after starting
the antiepileptic drug and continued through 24 weeks. These
results were consistent amongst the eleven drugs studied, and
the FDA believes that this risk is likely to be shared by all
antiepileptic medications.

For more information, please visit:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic


* * * *
WHAT DOES THIS MEAN?

Although the risk of suicidal thoughts and behavior appears to
be almost double that of placebo, its frequency remains lower
than 1 in 200 - and, and this stage, is unlikely to affect the
iGuard risk rating for ZONISAMIDE in otherwise healthy patients.


Since most conditions treated with antiepileptic products are
serious in nature, this communication is likely to help doctors
and patients watch more closely for suicidal thoughts and
behavior, especially in patients just starting treatment, but -
in most cases - is unlikely to result in changes in treatment.
That said, if you are taking any antiepileptic products and have
any suicidal thoughts, contact your doctor immediately.

onder:

 

[RobinN]

Rebecca was talking it out with a therapist, but I was warned by her to keep an eye and ear out. I am glad now that Rebecca is off this drug.

Oh my goodness, I just read the FDA page and all four that Rebecca took are here. She has had difficulty over this past year. In fact her therapist was even talking about a mood enhancer... which I said... I don't think so. Now this... who to trust.

 

[brain]

Suicide Risk From 11 Epilepsy Drugs - From WebMD 01/31/08

Epilepsy drugs linked to suicidal behavior

Just in case this gets
eliminated I have quoted it and added
some emphasis:

Epilepsy drugs linked to suicidal behavior
FDA finds patients face twice the risk of thoughts of suicide

updated 6:12 p.m. ET, Thurs., Jan. 31, 2008

WASHINGTON - Epilepsy drugs used by millions of people may increase the risk of suicidal thoughts or behavior, the U.S. Food and Drug Administration warned in an alert to doctors Thursday.

The FDA analyzed almost 200 studies of 11 different anti-seizure drugs, some that have been on the market for decades. The studies tracked almost 28,000 people given the medications and another 16,000 given dummy pills.

Very rarely were suicidal thoughts or behavior reported. Still, the FDA found drug-treated patients did face about twice the risk: 0.43 percent of drug-treated patients experienced suicidal thoughts or behavior compared with 0.22 percent of placebo-takers.

Overall, four people in the drug-treated groups committed suicide, and none in the placebo groups.

What that means: For every 1,000 patients, about two more drug-treated patients experienced suicidal thoughts than placebo-takers, FDA concluded.

Anti-seizure drugs are used for a variety of illnesses in addition to epilepsy, including migraines, certain nerve-pain disorders, and psychiatric diseases such as bipolar disorder that themselves carry a risk of suicide.

The FDA found drug-treated patients were at increased risk no matter their diagnosis, but that the risk was highest for epilepsy sufferers.

The FDA began investigating if epilepsy drugs pose any suicide risk in 2005. It analyzed data from 11 well-known anti-seizure drugs including Pfizer's Neurontin, Novartis AG's Tegretol and Abbott Laboratories' Depakote — but the FDA said it expected that the risk applied to every epilepsy drug. The FDA said it would work with manufacturers to add the warning to product labels.

Skipping epilepsy medication can result in seizures. An FDA spokeswoman said only that patients should ask a doctor before making medication changes.

But the agency's letter to doctors advised them to:

*Balance the risk with the patients' need for the drug.

*Tell patients and their families about the risk so they can be aware of changes in mood.

*Make sure patients and families know to contact a doctor if someone experiences common suicide warning signs, such as talking or thinking about hurting yourself, becoming preoccupied with death, withdrawal, becoming depressed or worsening depression, and giving away prized possessions.


© 2008 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

 

[brain]

Suicide Risk From 11 Epilepsy Drugs - From WebMD 01/31/08

Suicide Risk From 11 Epilepsy Drugs

Here is another Report with
the emphasis added being mine:

Suicide Risk From 11 Epilepsy Drugs
FDA Warns That Epilepsy Drugs May Double Risk of Suicidal Behavior, Thoughts
By Daniel J. DeNoon
WebMD Medical News
Reviewed by Louise Chang, MD

Jan 31, 2008 -- The FDA warns that 11 epilepsy drugs double a person's risk of suicidal behavior or thoughts, although the overall risk remains small.

The warning comes from an FDA analysis of suicidality -- suicidal behavior or thoughts -- in placebo-controlled studies of 11 drugs known collectively as "antiepileptics." The drugs are used to control seizures and to help control the symptoms of some psychiatric disorders.

"All patients who are currently taking or starting on any antiepileptic drug should be closely monitored for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression," the FDA warned in a letter to health professionals.

In the clinical trials, patients receiving inactive placebo pills had a 0.22% incidence of suicidality. Those receiving the epilepsy drugs had a 0.43% incidence of suicidality -- twice that of placebo recipients, but still a very small risk.

The drugs were relatively more likely to be linked to suicidality when used to treat epilepsy than when used to treat psychiatric disorders or other conditions.

The 11 drugs cited by the FDA are:

* 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)

Some of these drugs are available in generic forms.
View Article Sources Sources

FDA Alert: "Suicidality and Antiepileptic Drugs," Jan. 31, 2008.
© 2008 WebMD, LLC. All rights reserved.

 

[brain]

SP - I just posted the overall 11 AED and plus the major newsreport.

If you read them; it is a SMALL RISK.
I put the emphasis in the report so that
people won't over-react to the FDA's
and the Media's reports.

FDA plans on working on ALL AED's;
but we already know all AEDs carry a
risk anyway.

Zonegran / Zonisamide is on the
11 AED list - if you look at the WebMD
thread I have available.

I also have the UPDATED MSN Medical
NEWS (revised); because the original
one was in error. However, MSN should
have stressed the risk limitation factor
being SMALL like WebMD had done so.

Hence the reason why I had put the
post there.

BOTH NEWS ARTICLES FOUND HERE

 

[speber]

Thanks Brainy...

...but I was not trying to scare anyone...I was trying to point out the fact I got TWO IDENTICAL MAILINGS telling me to watch out for strange side effects--> with only the name of the drug changed in the whole article(s)!

I hoped the point would get across that at first it was something to go "Hmmm? OK, I'll be careful...whatever....that's a very small percentage...I'm not too worried." - and then with the second article people would have my reaction which was - "okay...now I don't believe a word of it because the odds of it being THAT identical are ridiculously low...hence, it's probably inaccurate so I'm DEFINITELY NOT worried!"

*sigh*....but thanks for the more in-depth link nonetheless!
:rock:

 

[speber]

Small Risk Mind You!...

...did I say "small risk"?

...cause I know Brain did.

...and it is a fact.

:mrt:

 

[brain]

SP - NOW you have me curious!

No Problem SP!

But 2 emails on individualized
Medications? How the heck did you
managed to accomplish that feat?

You've got me curious as heck!

onder:

 

[Bernard]

All the more reason, IMHO, to view AEDs as short term solutions to get seizures under control. I think the medical industry should really be focusing on diets, CBT and EEG neurofeedback for long term results that don't carry such high risks (and other quality of life consequences).

 

[Bernard]

The studies tracked almost 28,000 people given the medications and another 16,000 given dummy pills.

The question that comes to my mind is... were the 16,000 people taking placebos also suffering with seizures? I wonder how much depression and quality of life issues related to epilepsy is influencing the results here.

 

[Bernard]

I've merged the 3 threads on this subject together since they are really all on the same subject.

 

[wonderdogs]

I just got to work and my husband had e-mailed me the link to this story on Yahoo! News so I came here immediately and what do you know, you all are already discussing it!

I have not had any issues since I have been on the Keppra. I do have a history of depression and I take antidepressant medication. It runs in my family so I have accepted that there is just something chemically off-balance that is beyond my control. The instant I come off the antidepressant my irritablity returns and I am a basket case.

What if the cause of my epilepsy is unknown? How do I determine what alternative treatments will work?

 

[speber]

Cue Bobby!....


:rock:....rasta man!

 

[Bernard]

What if the cause of my epilepsy is unknown? How do I determine what alternative treatments will work?

The same way you find out if drugs will work... trial and error...

 

[Birdbomb]

This is a really hot topic in the ECT and depression sites. Mainly because most people didn't realize the same medications are being used for both depressive and seizure disorders.

I know from my own personal experiance with 4 of these medications, I had suicial thoughts and after a little research I found that it was a side effect.

Sometimes I wonder how doctors can sleep at night knowing what they are doing is more harmful than good. So many people on AED's complain of depression and here it is in black and white!

 

[tinasmom]

I received an email this morning from the program director at our local Epilepsy chapter regarding this issue. I know that there is a small risk but my feelings are that if even one person commits suicide because of a med that is suppose to help them, that is too many. I also think that creating meds that are suppose to help numerous conditions involving the brain is just causing problems. It seems that they want a one pill cures all.

 

[xenome]

I feel suicidal alot, but I think its caused by the fact that I have seizures to begin with, not the drugs Im taking. Having epilepsy is a horrible thing to have, especially when its uncontrolled like mine are so why would people blame the pills and not the disease?