Suicide warning to be placed on mood stabilizers

Discussion in 'General Parenting' started by Sara PA, Jun 6, 2008.

  1. Sara PA

    Sara PA New Member

    The warning is going to be placed on 11 anticonvulsants including all three of the anticonvulsants used as mood stabilizers -- Lamictal, Tegretol/Trileptal and Depakote as well as Topamax. (ETA: Unlike what is on antidepressants, this is not going to be a black box warning.)

    Epilepsy Drugs to Get Suicide Warnings, FDA Confirms

    Date Published: Friday, June 6th, 2008

    US regulators are very close to finalizing new suicide warnings for 11 epilepsy drugs, The Wall Street Journal reported today. This past January, the Food & Drug Administration (FDA) issued an Early Communication announcing a safety review of the epilepsy drugs after a study showed they increased patients' risk of suicidal thoughts and behavior.

    The 11 epilepsy drugs slated for a new suicide warning 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)

    In addition to treating epilepsy, the anti-seizure medications are used for a variety of other illnesses, including migraines, certain nerve-pain disorders, and psychiatric diseases such as bipolar disorder that themselves carry a risk of suicide.

    The FDA began investigating if epilepsy drugs posed any suicide risk in 2005. In doing so, the FDA analyzed almost 200 studies of 11 anti-seizure drugs, some that have been on the market for decades. The studies tracked almost 28,000 people given epilepsy medications and another 16,000 given dummy pills.

    According to the FDA, 0.43 percent of drug-treated patients experienced suicidal thoughts or behavior, compared with 0.22 percent of placebo-takers. The higher risk of suicidal thoughts and behaviors was observed at one week after starting a drug and continued to at least 24 weeks. The results were generally consistent among all the different drug products studied and were seen in all demographic subgroups. Overall, four people in the drug-treated groups committed suicide, and none in the placebo groups. For every 1,000 patients, about two more patients taking epilepsy drugs experienced suicidal thoughts than those who took placebo.

    In an interview with The Wall Street Journal, Russell Katz, director the FDA's neuropharmacological drug division confirmed the suicide warnings are coming. 'We are working on the labeling changes that we want to get to the companies,' he said. An FDA advisory panel is slated to take up the issue of epilepsy drugs and suicide on July 10, but the Journal speculated the new warnings could come even sooner than that.

    At least one drug maker, Pfizer Inc., is less than pleased at this development. Pfizer disputed the FDA's analysis in a forum this week sponsored by the Epilepsy Study Consortium in New York. Pfizer especially disputes the inclusion of Lyrica - one of the company's biggest growth drivers -on the FDA's warning list. Pfizer said that Lyrica accounted for only 6.3% of the total 142 suicidal events cited by the FDA analysis. But the FDA is sticking to its guns, and the new suicide warning will apply to all 11 epilepsy drugs.

    Most other epilepsy drug makers are resigned to the label changes, according to the Journal. GlaxoSmithKline, the maker of Lamictal, approached the FDA this year to volunteer changes regarding possible suicidal-behavior risks. Other drug makers may have chosen not to challenge the FDA on suicide warnings because their medications are no longer as lucrative as they once were, as patents on many epilepsy drugs have, or are close to, expiring.
     
  2. susiestar

    susiestar Roll With It

    Thanks for letting me know. I will have to keep on top of things with Jess, esp as we are getting ready to tweak her medications.
     
  3. gcvmom

    gcvmom Here we go again!

    I'd be curious to know the breakdown of diagnoses for the people who participated in the study. How many were mood disordered, how many were epileptic, how many were migraines, etc.
     
  4. TerryJ2

    TerryJ2 Well-Known Member

    Good. I'm glad some progress is being made.
    I have an elderly cousin who is on a combination of things, including two on the list. Serious stuff.
     
  5. crazymama30

    crazymama30 Active Member

    I agree gcvmom, I would be interested in knowing that also.
     
  6. flutterbee

    flutterbee Guest

    This is from MSNBC, published in January:

    http://ori.msnbc.msn.com/id/22936892/
     
  7. Sara PA

    Sara PA New Member

    I have long read that people with controlled seizures are at greater risk for depression (which may explain why ECT is a treatment for depression) than people with uncontrolled seizures. Admittedly suicidality and depression are two different things, but I wonder if that is a factor in the higher rate for people with epilepsy.
     
  8. slsh

    slsh member since 1999

    Very very interesting. I wonder what the physiology is that makes folks with controlled seizures at greater risk?

    All 3 of Boo's epilepsy medications are on this list - joy oh joy. Fortunately, he seems to be the most even-keeled person in the family mood-wise, LOL.

    Really seems like a catch-22 in some ways - when we tried to start weaning him off Carbatrol earlier this year, the neuro warned us about his mood possibly taking a dive. Yet he's at increased risk to be suicidal *on* the medication too? Yuck.
     
  9. Sara PA

    Sara PA New Member

    I have to say that I was suicidal from time to time before I took anticonvulsants (I took Dilantin and Tegretol) and never after I started taking them. I did have a major depressive episode after being on Dilantin and my seizure were controlled for about five years. I had no depressive episodes while taking Tegretol. However, I called my son who took Lamictal and told him about this and he wasn't surprised in the least. Thinking about it, it was after he quit the Lamictal that I became less fearful about him killing himself. We assumed he was just continuing to heal from the damage done by the Celexa; maybe the Lamictal was part of the problem. Once off Lamictal, any suicidal talk was related to how unhappy and miserable his life -- or lack of a life -- had become, that I-hate-my-life talk, different from what he expressed before.
     
  10. crazymama30

    crazymama30 Active Member

    With my son he is way more depressed without his Lamictal. With the mood disorders, doesn't that mean that someone with that diagnosis is statistically more likely to commit suicide? It doesn't explain why people with seizures who are treated with those medications are more likely to committ suicide, but I just thought of it and it made me think.
     
  11. Sara PA

    Sara PA New Member

    Depression and suiciality really aren't as connected as most people think. They are related and often found in the same person but the genetic material that controls depression isn't the same stuff that controls suicidality. Not everyone who has suicidal ideation is depressed, particularly those whose suicidal ideation is the result of an adverse reaction to a medication. Suicide can be an impulsive, compulsive act, unrelated to depression.

    Drugs are tested using double blind studies, both on patients with the disorder being treated and on "healthy" patients. That protocol controls for the diagnosis being the cause of the reaction rather than the drug.

    From the article "Overall, four people in the drug-treated groups committed suicide, and none in the placebo groups. For every 1,000 patients, about two more patients taking epilepsy drugs experienced suicidal thoughts than those who took placebo." If it were indeed the disorder and not the drug, one would expect that the suicidal ideation and acts among the placebo group would be the same as the group taking the drugs. When that's not the case, the drug is suspect. Just like outperforming the placebo indicates the drug is effective, a higher number of adverse reactions than the placebo indicates the drug is at fault.
     
  12. crazymama30

    crazymama30 Active Member

    Sara, I was speaking more towards bipolar, not necessarily just depression. I am sure that for some people the drug would increase their chance of committing suicide.
     
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