Epilepsy Drug Suicide Warnings Added by FDA

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The FDA is requiring the manufacturers of 11 different epilepsy drugs, such as Lamictal, Lyrica, Topamax and Depakote, to warn about potential side effects that may increase the risk of suicide and suicidal thoughts.

About 2.7 million Americans have epilepsy, and the anti-seizure drugs generate sales of over $10 billion a year, making them the fifth best-selling class of medications in the United States.

FDA officials originally indicated earlier this year that the medications should carry a “black box” warning about the suicide side effects of the epilepsy drugs, which would be the strongest warning that can be placed on a prescription medication.

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However, a panel of independent advisors to the FDA met in July 2008, and concluded that that a “black box” suicide warning was not appropriate.

In a statement released December 16, 2008, the FDA indicates that they have completed their analysis of data involving suicides and suicidal thoughts with the drugs used to treat epilepsy, psychiatric disorders and other conditions.

Based on their review, the FDA is requiring all manufacturers to add information about the risk of suicidal thoughts an actions to the Warning section of their labeling and to develop a Medication Guide which will be provided to patients receiving the drugs.

The 11 epilepsy drugs which will carry the new suicide warnings include: 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); and Zonisamide (marketed as Zonegran).

The FDA indicates that they have reviewed data from nearly 200 clinical trials, which indicate that those taking one of the epilepsy drugs are nearly twice as likely to experience suicidal behavior or thoughts when compared to those taking a placebo.

For every 500 patients treated with an antiepileptic drug, the FDA suggests that one additional suicide could be caused.

Healthcare providers have been asked to notify patients, their families and caregivers about the potential epilepsy drug suicide side effects, so that they can watch for unusual behavior or suicidal thoughts.

Tags: Carbatrol, Depacon, Depakene, Depakote, Epilepsy, Epilepsy Drug, Equetro, Felbatol, Gabitril, Keppra, Lamictal, Lyrica, Neurontin, Suicide, Tegretol, Topamax, Trileptal, Zonegran

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64 Comments

Nikki
I have taken Lyrica for almost 3 years as of May I had nerve pain which long story short they treated my back and after 3 years found out it was a tumor growing on my tibial nerve that they removed but continuous suicidal thoughts and attempt to end my life in March,2009 as a result of taking Lyrica the pain specialist had me on lyrica 50 mg 3 a day and lyrica 75 mg 3 a day If it wasn’t for my roommate I would have died. My aunt noticed a commercial here in chicago about lawsuits with Lyrica and after she heard my case has been trying to get the # down to call but no longer see’s the commercial does anyone have a # to an attorney please????
James
I have had severe mood swings while taking this medication.I was locked up for 3 days under suicide watch.I was originally given Lyrica for neck surgery,then a year later given Lyrica for back surgery.I was told take it when you are hurting I was never told about with drawl upon discontinuing taking.I also have eye problems now I never had before
melody
I have been on Lyrica for about 8months to a year, just put on topamax and have been taking Neurontin on and off for about a year for extreme pain due to M.V.P accident. I stopped all of them at the same time and am having great withdrawls. I can hardly stand myself. I am so sick feel funny weird hot and cold flu like scarey for me but I don’t want to die and the Meds scare me more. I am now wondering if my Dr. is compitent to treat me or anyone else. I am feeling pissed off that someone could be put on such high doses and they all cause you to feel like death is better then being in pain eveyday. Minnesota I am wondering what I should do about all of this any advice?????
Melissa
My mother was on Depakote for 5 years and then she went to a new doctor and he changed the Depakote that was working very well I might add to Keppra. She is now in the hospital and because of the suicidal thoughts and deppresion that she has had. They have started her back on Depakote and she if fine.
samantha
If you were suicidal and they put you on medication that has a side affect known by the fda that causes suicidal thoughts of course you didnt get any better you wanted to die we are talking about people that never felt this way until taking the drug your problem cant be projected onto other, she said” with no warning, he was not suicidal or gave no indication he was.’ meaning he was never that way until he started taking the medication. What about patients that are only having seizures what about them they come in for seizures and leave with suicidal thoughts …explain that
Dixie
You have my deepest sympathies! Suicide happens when the person is in such a terrible dark depression that s/he isn’t even thinking—it’s like an animal dying of thirst, rushing toward a lake. You just want the pain to end. I have been on Depakote for 15 years. I was suicidal before taking Depakote. I did not get more or less suicidal from Depakote. I got on Seroquel & the suicidal thoughts stopped after I’d been on it faithfully for 4 weeks. Everyone is different. But ALL psychotropic meds take AT LEAST 4 weeks to have any real effect on a person. The meds build up in the brain, blood system & fatty tissue & then begin sending out the right chemistry. So NO WAY did Depakote cause anyone to commit suicide. Your son was, sadly, already so down that he was ready for this tragic step.
Kathleen
Our son was prescribed Depakote about 3-4 weeks ago and just commited suicide last night, with no warning, he was not suicidal or gave no indication he was.
KA
I too am concerned about some of these drugs. As a consumer, and now as a provider, I think they should be a last resort drug. I still take topamax 75 mgs a day, but had been on as much as 200 until I could no longer tell what was real from what was not. I have also coupled my topamax with lamictal until the headaches and other side effects were too severe to bare- I then coupled gabitril with the topamax and my life further went downhill. I was completely suicidal for years, it was a driving force… so painful. Akathesia with the gabitril made me feel like I was trying to rip myself apart only to keep running and begged to be held down. I could not see properly, I became mute outside of the muttering I had to do to channel the voices in my head that would not stop… Then with the gabitrl came the twitches in my eye, my arms and legs jerking like I had epilepsy. Still I had the fire like headaches, and only wanted to remove my head from my body. That was it, self-esteem gone- I could no longer see in color and I could not see myself reflected back when I looked in the mirror. Family ran, nobody to talk me through the agony… Finally I ended the meds cold turkey… all but the 75 mgs of the topamax and a benzo In a last ditch effort to save myself… Psychosis set in for a few months… but I made it… I took me a year to recover from two years of intense mental illness. now I take the 75mgs, a tricyclic, and a small amount of a benzo. I have fears that anything can set me back again, but stay away from large doses or any new sort of designer meds I will. I work in a field now assisting those in mental health crisis and when I see their long lists of meds I want to pick of the phone and call the AMA or the FDA and say “take a look at this nightmare” the meds are costing people their lives and only making their mental health issues worse… or creating new symptoms.
Kathleen
Someone very dear to me committed suicide last year. He had been taking 1600 mg of Topamax/day as a mood stabilizer for being bipolar. There are two others I know who were also taking this dose for the same condition. A few months ago, both people had a strong intuition to no longer take Topamax, though they didn’t discuss it with one another. One went for a second opinion — the specialist was horrified at the dose and agreed that another solution should be pursued. Both patients stopped taking Topamax, and eventually all medications, and now feel better than they have in years. The prescribing doctor was allegedly in contact with the manufacturer regarding high dose useage. I wrote to the manufacturer to ask about this, and received no reply. I would like, however, to warn others that this dose should be questioned if prescribed. I am highly suspect of the role Topamax had in the suicide mentioned above, as the person was driven by anxiety, and this drug can increase and/or cause anxiety.
Holly
My 20 year old son hanged himself a few months ago after having been prescribed Dilantin. I am an RN and pleaded with the ER doc NOT to prescribe it to him because he was depressed. No one gives a shit that paramedics took 40 minutes to arrive-from 2.1 miles away, then refused to do anything based on the ASSUMPTION that his neck was broken. It wasn’t, according to the medical examiner……….so they just let him die, in my home…….because they “ASSUMED”. Then, if that weren’t enough, the paramedics “log” of events showed timely arrival and 44 minutes of care, including defibrillation. I was there, along with 2 neighbors…..they are flat out lying. And, whats worse…I cut him down, he had a pulse. I could’ve saved him had I lot been freaking out.
bemcmillen
My husband committed suicide after being on depakote for 2 weeks.
Kris
Rebecca, PLEASE talk to your doctor about your suicidal thoughts. My brother-in-law didn’t speak to anyone, and now he is gone. If your doctor won’t listen to you, then find a better doctor. Please. Do it for the people who love you.
Kris
My brother-in-law committed suicide in mid January of 2009 by ingesting a fatal amount of Lyrica, which he’d been prescribed for neuropathy. I’m extremely concerned about the safety of this medication and am worried that it caused his death.
Rebecca
I have been taking Trileptal constantly (450 mg a day) to treat Bipolar I since 2003. It worked very well for the first four years or so, but around January of 2007 I started having uncontrollable panic attacks and anxiety. This worsened over time, and although I lowered my dosage to 300 mg a day, now I have suicidal thoughts all the time. I have been very depressed, and although normally I am a social creature I do not leave my house. When I eat, I become very ill most of the time. Every time I inquire about ceasing the Trileptal usage my psychiatrists tell me this is just a “natural” desire for Bipolars to think they no longer need medicine and talk me out of stopping the drugs. I stay with my parents sometimes because I’m scared of what I am like sometimes.
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