Antiepileptic Drugs Side Effects

Patients who take antiepileptic drugs for epilepsy, bipolar disorder or migraine headaches should be aware of an increased risk of suicidal thoughts and behavior, according to a new alert from the U.S. Food and Drug Administration (FDA).

Antiepileptic drugs specifically covered by a Jan. 31 FDA alert 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)

According to an FDA analysis, patients taking those drugs had nearly twice the risk of suicidal thoughts and behaviors when compared with patients who took a placebo.

“This risk corresponds to an estimated 2.1 per 1,000 more patients in the drug treatment groups who experienced suicidality than in the placebo groups,” an FDA release stated.

The FDA requested data from antiepileptic drug makers in March 2005. A preliminary analysis appeared to point to an increased risk of suicidality among patients taking those drugs.

The FDA reviewed data from 199 placebo-controlled studies of 11 drugs. The agency’s analysis looked at 27,863 patients in drug treatment groups and 16,029 patients in placebo groups.

Among the findings:

• Among patients who were taking antiepileptic drugs, there were four suicides. In contrast, there were none among patients who took placebos.
• There were 105 reports of suicidal thoughts or behaviors in the drug-treated patients, compared to 35 reports in placebo-treated patients.
• The elevated risk of suicidal thoughts and behaviors began one week after patients started taking a drug and continued to at least 24 weeks.
• The results were generally consistent among all the different drug products studied and in all demographic subgroups.

All medications in the antiepileptic class – including those that were not studied – likely share the increased risk of suicidality, the FDA said.

Patients who are currently taking antiepileptic medicines should not make any changes without first talking to their healthcare provider, the FDA said. The agency asked healthcare providers to notify patients and others of the potential for increased suicidal ideation.

The FDA is expected to have manufacturers of antiepileptic drugs include this new risk information in their product labeling.

If you, or a loved one, have been prescribed any of these antiepileptic drugs and suffered from any of the serious side effects discussed in the FDA alert, you should consider consulting with a law firm that can investigate your potential claim. Only a skilled prescription litigation attorney has the experience and resources to thoroughly investigate and validate your case.

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