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The U.S. Food and Drug Administration issued a healthcare provider alert for 11 antiepileptic medications because of the potential increased risk of suicidal behavior or ideation. Previous warnings have already raised awareness of the potential risks; however, now the FDA is formally requiring all medications in this class carry specific warnings on their labeling. Healthcare providers are being alerted to the heightened risk so they may evaluate prescribing practices and carefully warn patients and their caregivers to be alert for warning signs.

Drugs requiring close monitoring include carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol XR), felbamate (Felbatol), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), oxcarbazepine (Trileptal), pregabalin (Lyrica), tiagabine (Gabitril), topiramate (Topamax), valproate (Depakote, Depakote ER, Depakene, Depacon), and zonisamide (Zonegran). The FDA will soon post informational handouts that can be given to patients to alert them to the risks and need for additional monitoring.

The most recent research reviewed by the FDA, which included placebo-controlled clinical trials of antiepileptic drugs used to treat epilepsy, psychiatric disorders, and other conditions (including neuropathy and fibromyalgia), suggested an increase in worsening depression and suicidal thoughts when antidepressants were prescribed. In the FDA’s analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving 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.

Healthcare professionals and caregivers should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression. Monitoring is also advised when dosage adjustments are made.

Patient and caregiver teaching: Stress close observation of patients receiving antiepileptic drugs. Behavioral symptoms to watch for include anxiety, irritability, agitation, impulsivity, hostility, and panic attacks. Physical signs for concern can include insomnia and extreme restlessness. In patients being treated (off label) with antiepileptic drugs for bipolar disorder, manic episodes may be especially profound, providing unbounded energy to carry out suicidal ideation. Patients should be advised to immediately seek medical attention for any signs or symptoms suggesting suicidal behavior or ideation. Also, be sure to warn patients not to stop antiepileptic medications without talking with their healthcare provider.

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Drug News is compiled by Susanne J. Pavlovich-Danis, RN, MSN, ARNP-C, CDE, CRRN, who maintains a private practice in Plantation, Fla., and is professor and area chair for nursing at the University of Phoenix, Fort Lauderdale.