FDA Alert for Antiepileptic Drugs (Also Used for Fibromyalgia, Migraines, Neuropathic Pain, etc.)

Karen Lee Richards Health Guide
  • The FDA has analyzed reports of suicidal behavior or ideation from placebo-controlled clinical studies of eleven drugs used to treat epilepsy, psychiatric disorders, and a number of other conditions such as fibromyalgia, Migraines, and neuropathic pain. What they found was that patients receiving these drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving a 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 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.
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    The drugs included in the analyses 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)
    • Zonisamide (marketed as Zonegran)

    Since the results were generally consistent among the 11 drugs tested, the FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and they anticipate that the class labeling changes will be applied broadly.


    If you are taking any of these drugs and begin to have symptoms of depression or notice an increase in depression, or begin to have suicidal thoughts, contact your doctor right away.


    For more information about this study, read MyMigraineConnection Expert Teri Robert's article: Risk of Suicidal Thoughts Linked to Anticonvulsant Medications  


    Click here to read the complete 2008 MedWatch Safety Summary including a link to the Healthcare Professional Sheet.

Published On: January 31, 2008