Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly.
The FDA offers the information for patients taking these medications and their family members and caregivers:
- Taking antiepileptic medicines may increase the risk of having suicidal thoughts or actions;
- Do not make any changes to the medication regimen without first talking with the responsible healthcare professional;
- Pay close attention to any day-to-day changes in mood, behavior and actions. These changes can happen very quickly so it is important to be mindful of any sudden differences.
- Be aware of common warning signs that might be a signal for risk of suicide. Some of these are:
- Talking or thinking about wanting to hurt yourself or end your life
- Withdrawing from friends and family
- Becoming depressed or having your depression get worse
- Becoming preoccupied with death and dying
- Giving away prized possessions
If you notice any of these issues, contact your doctor immediately.
Johnson & Johnson, the manufacturer of Topamax stated that there is already information about suicide attempts in the Topamax labeling. Pfizer has issued a statement saying based on a review of clinical trials and post-marketing reports, they haven't identified any evidence of increased risk of suicide-related events in Lyrica or Neurontin. GlaxoSmithKline, the manufacturer of Lamictal, reported that they would work with the FDA to update the labeling of Lamictal.
The FDA will be working with manufacturers of these medications to revise labeling to include appropriate warnings about suicidal thoughts or ideation.
Adverse reactions to neuronal stabilizing agents or other medications should be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Online: www.fda.gov/medwatch/report.htm
- Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm.
- Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
- Fax: 1-800-FDA-0178
