The Food and Drug Administration (FDA) has completed a review of clinical trial data on antiepilepsy drugs (antiepileptics) that was conducted to determine whether they pose the risk of suicidal thought and behavior (suicidality). Antiepileptics are used not only to treat and prevent seizure in epilepsy, but also to treat psychiatric disorders, migraine headache, and other conditions. The agency reviewed 199 clinical trials of 11 antiepileptics and determined that patients who took an antiepileptic either alone or as part of combination therapy had almost twice the risk of suicidal thought or behavior compared with those who did not, a difference representing one in every 530 patients treated. The greater risk was observed as soon as one week after initiating treatment and persisted throughout. As a result of the findings the FDA will require manufacturers of all antiepileptics to include in the product labeling a warning and information for patients concerning the risk of suicidality posed by the medications. They will also be required to create a medication guide that will accompany each filled prescription to inform patients of the risk of suicidality and its signs and symptoms.
Nurses should teach patients about this risk and advise them and their families or caregivers that if sudden changes in the patients' mood or behavior occur, they should not stop using the medication, which could induce seizure, but instead immediately contact the prescriber. Nurses, other health care practitioners, family members, and caregivers should report instances of suicidality possibly induced by antiepileptics to the FDA MedWatch program at http://www.fda.gov/medwatch.
Antiepileptics to Have Revised Labeling Warning of the Risk of Suicidality
Carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol-XR)
Clonazepam (Klonopin)
Clorazepate (Tranxene)
Divalproex sodium (Depakote, Depakote ER)
Ethosuximide (Zarontin)
Ethotoin (Peganone)
Felbamate (Felbatol)
Gabapentin (Neurontin)
Lacosamide (Vimpat)
Lamotrigine (Lamictal)
Levetiracetam (Keppra)
Mephenytoin (Mesantoin)
Methsuximide (Celontin)
Oxcarbazepine (Trileptal)
Phenytoin (Dilantin, Phenytek)
Pregabalin (Lyrica)
Primidone (Mysoline)
Rufinamide (Banzel)
Tiagabine (Gabitril)
Topiramate (Topamax)
Trimethadione (Tridione)
Valproic acid (Depakene, Stavzor)
Zonisamide (Zonegran)
FDA requires warnings about risk of suicidal thoughts and behavior for antiepileptic medications [press release]. FDA News 2008 Dec 16. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01927.html; Center for Drug Evaluation and Research. FDA public health advisory: suicidal thoughts and behavior antiepileptic drugs. 2008 Dec 16. http://www.fda.gov/cder/drug/advisory/antiepileptics.htm.