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Suicidal Behavior and Ideation and Antiepileptic Drugs
FDA ALERT [1/31/2008, Updated 12/16/2008] - The FDA has completed its analysis of reports of suicidality (suicidal behavior or ideation [thoughts]) from placebo-controlled clinical trials of drugs used to treat epilepsy, psychiatric disorders, and other conditions. Based on the outcome of this review, FDA is requiring, under the authorities granted under the Food and Drug Administration Amendments Act (FDAAA) of 2007, that all manufacturers of drugs in this class include a Warning in their labeling and develop a Medication Guide to be provided to patients prescribed these drugs to inform them of the risks of suicidal thoughts or actions.
The drugs affected by these safety labeling changes are commonly referred to as antiepileptic or anticonvulsant drugs (see the list below). FDA’s pooled analyses of 199 clinical trials of eleven antiepileptic drugs used as mono- and adjunctive therapies showed that patients who were randomized to receive one of the antiepileptic drugs had almost twice the risk of suicidal behavior or ideation (0.43%) compared to patients randomized to receive placebo (0.24%). This increase in the risk of suicidal thoughts or behavior represents the occurrence of approximately one additional case of suicidal thinking or behavior for every 530 patients treated with an antiepileptic drug.
The risk of suicidal thoughts or behavior was generally consistent among the eleven drugs analyzed and was observed in patients who were treated for epilepsy, psychiatric disorders, and other conditions. The relative risk for suicidal thoughts or behavior was higher in the clinical trials for epilepsy compared to trials for psychiatric or other conditions. However, the absolute risk differences were similar in the clinical trials for epilepsy and psychiatric indications.
The increased risk was observed as early as one week after starting antiepileptic drug treatment and throughout the observed duration of treatment. The increased risk of suicidal thoughts or behavior was generally consistent among the eleven drugs with varying mechanisms of action and across a range of indications. This observation suggests that the risk applies to all antiepileptic drugs used for any indication.
All patients who are currently taking or starting on any antiepileptic drug for any indication should be monitored for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.
This information reflects FDA’s current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug products and the emerging safety issue. Nor does it mean that FDA is advising health care professionals to discontinue prescribing these products. FDA intends to update this document when additional information or analyses become available.
- Healthcare Professional Information
- Other Information
- Historical Information
The following is a list of antiepileptic drugs* included in the analyses:
Labeling and approval history from Drugs@FDA.
* Some of these drugs are also available in generic form.
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Date created: January 31, 2008, updated December 19, 2008 |
