The United States Food and Drug Administration (FDA) has evaluated the risk of suicide associated with antiepileptic drugs. The FDA examined 11 antiepileptic drugs, among nearly 28,000 patients, and found that patients taking an antiepileptic drug have an increased risk for suicidal behavior or ideation, compared to 16,000 patients receiving a placebo.

The FDA’s assessment consisted of reviewing 199 placebo-controlled trials evaluating the safety and efficacy of various antiepileptic drugs (also known as anticonvulsants). The following drugs were included in the review: carbamazepine (Carbatrol, Tegretol), felbamate (Felbatol), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), oxcarbazepine (Trileptal), pregabalin (Lyrica), tiagabine (Gabitril), topiramate (Topamax), valproate (Depakote, Depakene, Depacon), and zonisamide (Zonegran). Although only these drugs were included in the review, experts suggest that all anticonvulsant drugs carry the same risk. Antiepileptic drugs are not just used to treat epilepsy. They can be used to treat psychiatric disorders, including bipolar disorder, depression, and anxiety, as well as migraines and neuropathic pain.

Overall, the risk of suicide is double for patients receiving an antiepileptic drug, compared to patients receiving a placebo. Approximately 2 patients per 1000 exhibited suicidal thoughts or behaviors when treated with an antiepileptic drug. A total of 4 patients completed suicide among the treatment groups, while no suicides occurred in the placebo groups. The risk for suicidal thoughts and behaviors was higher in patients with epilepsy, versus psychiatric or other conditions, in the FDA’s evaluation.

All of the drugs evaluated in the study appear to have a similar risk of suicidal thoughts and behaviors. The risk was also consistent across all major demographic groups studied. Only patients aged 5 years or older were included in this analysis, with an average age of 42 years. Slightly more than half of the patients were female and more than three-quarters were white. The only subgroup of patients that showed a slightly higher risk of suicidal behavior was non-North American patients, versus patients who resided in North America. 61% of patients evaluated were from North American locations.

The increased risk of suicide was seen as early as one week after starting treatment with an antiepileptic drug, and continued for at least 24 weeks. (Most of the trials included in the review did not extend past 24 weeks, so suicidal thoughts and behaviors after this time cannot be accurately assessed.)

Healthcare professionals are advised to use this information when prescribing antiepileptic drugs for any patients. The risks associated with the drugs should be balanced with the benefit obtained from the treatment.

Patients and families must also be aware of the risks associated with antiepileptic drugs and monitor patients for emerging or worsening depression, anxiety, hostility, or mania. Patients should not stop taking an antiepileptic drug without first discussing it with their healthcare providers.

The FDA is currently working with manufacturers of antiepileptic drugs to require additional safety information and warnings in the each of the drug’s labeling.

Reference

FDA. Statistical Review and Evaluation: Antiepileptic Drugs and Suicidality. 2008.

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