FDA Labeling Position
Statement from the American Epilepsy Society
In response to the December 16, 2008, FDA announcement about suicide warnings that will now be required on all antiepileptic drugs. Epileptic seizures are serious, potentially life-threatening events. The American Epilepsy Society urges patients with epilepsy to continue to take their seizure medications as prescribed. Any patient experiencing symptoms of depression or suicidal thoughts should inform their physician as soon as possible.
On December 16, 2008, the FDA announced its decision to require warnings concerning suicidal thoughts or behavior in the prescribing information for antiepileptic drugs. The FDA has raised an important issue. However, the American Epilepsy Society has questions about the methods used in the FDA analysis, and concerns about generalizing the findings to all seizure medications, not just those studied in the FDA's analysis. We believe that further study is needed to evaluate the FDA's conclusions and, if confirmed, to identify which patients might be at particular risk.
Furthermore, patients with epilepsy and their families need to put the FDA's findings in perspective. As the FDA mentions in its announcement, "This difference was about one additional case of suicidal thoughts or behavior for every 500 patients treated with antiepileptic drugs or placebo". This risk must be assessed against the potential dangers of leaving a person with epilepsy untreated.
Epilepsy can be a very serious condition if untreated and seizure medicines can be life saving. As with any medical condition, the risks and benefits of starting or continuing seizure medicines should guide physicians when recommending treatment for epilepsy.
Physicians have known for some time that certain seizure medicines can worsen mood, particularly in patients with pre-existing mood disorders or a family history of mood disorders. Patients on seizure medicines should be periodically evaluated for side effects, including possible effects on mood. But we also know that many patients with epilepsy also have depression, and the reasons for depression are multiple. Therefore, physicians should identify the possible causes of depression in a patient with epilepsy and not automatically assume it is a side effect of seizure medicine.
The American Epilepsy Society is dedicated to the prevention, treatment and cure of epilepsy. The Society’s primary concern in the treatment of epilepsy is the safety and well being of patients who have the disorder. The American Epilepsy Society is committed to working with physicians so that people with epilepsy receive optimal care and that physicians have the information they need to discuss all of the risks of treatment with their patients.# # #
West Hartford, CT
December 19, 2008