The U.S. Food and Drug Administration (FDA) is requiring warnings on a laundry list of antiepileptic medications that say that use of the drugs increases the risk of suicidal thoughts and behaviors.
Physicians prescribe the medications of concern for more than seizure disorders, including for things like bipolar disorder and migraine headaches.
The companies that manufacture the medications have 30 days to submit new labeling or to let the FDA know why they believe the changes are unnecessary. The FDA can implement enforcement action with any company that fails to comply. In addition, manufactures of each drug will need to create a Medication Guide for patients with information about the risks of suicidal thoughts and behaviors that the FDA approves. They will also have to submit a Risk Evaluation and Mitigation Strategy to the FDA.
The agency reviewed 199 clinical trials of 11 antiepileptic drugs and found a risk of suicidal behavior and thoughts of patients on antiepileptic drugs to be about double that of those on a placebo medication, which results in an absolute risk of about one additional case of suicide for every 500 individuals taking the medications. Four of the patients who received an antiepileptic drug committed suicide, but none in the placebo group did, although no broad conclusions were drawn based on this.
Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research said that all patients on these medications need monitoring for signs of new or worsening depression, suicidal thoughts or behavior, and mood or behavior changes.
Despite the warnings, FDA says that patients should not discontinue the medications abruptly and should work with their physicians to weigh the risks and benefits of their individual treatment plan.