subject: FDA Advisory Members Agree Antiepileptics Pose Suicidality Risk [print this page] FDA Advisory Members Agree Antiepileptics Pose Suicidality Risk
Early this month a panel of members from the FDA met to discuss the reports that antiepileptic drugs (AEDs) could potentially increase the risk of suicidality (suicidal ideation and behavior). The FDA requested all antiepileptic drug manufacturers give them data from their trials (a total of 199 trials) after one manufacturer reported an increased risk.
After reviewing the information the panel unanimously agreed that of the 11 drugs in question ALL posed the risk of increased suicidality. Interestingly they voted strongly against a black box warning (the strongest FDA warning) based on the concerns of a "hysteric reaction" where patients would overreact and would lead to a shift in prescribing drugs that were not "as well studied." Instead they voted in favor of providing a patient medication guide which would be included with all prescriptions for the 11 drugs in questions.
The antiepileptic drugs in question included:
Carbamazepine: Carbatrol from Shire Pharmaceuticals, Equetro fromm Validus Pharmaceuticals and Tegretol from Novartis Pharmaceuticals
Felbamate: Felbatol from Meda Pharmaceuticals
Gabapentin: Neurontin from Pfizer
Lamotrigine: Lamictal from GlaxoSmithKline
Levetiracetam: Keppra from UCB
Oxcarbazepine: Trileptal from Novartis Pharmaceuticals
Pregabalin: Lyrica from Pfizer
Tiagabine: Gabitril from Cephalon
Topiramate: Topamax from Ortho-McNeil-Janssen Pharmaceuitcals
Valproate: Depakote from Abbot Laboratoreis
Zonisamide: Zonegran from Dainippon
Seizures (epilepsy) is a dangerous disorder and can lead to many cognitive and behavior disorders. It is important that we find the appropriate treatment for our children who suffer with this challenge. I have many patients who suffer from seizures and this report from the FDA raised quite a stir among the office. To know that a young child is on a medication that could potentially increase suidicidality is a tough thing to swallow, but these medications are vital to keeping seizure disorders under control.
We have found that there are many identifiable causes of seizures that can be corrected, or at least minimized. Some common causes I run into are food allergies, transient hypoglycemia and immunodeficiency syndromes (if interested please ask me for studies that prove the associations). Once these are identified and corrected, we can see seizure activity diminish.
There are also many natural and nutritional supplements that can decrease seizure activity and thus lead to a lowering of medication. These include Vitamin B6, Magnesium, Taurine, Carnitine, Omega-3 oils and others. One of the mainstays in our office is Omega-3 oils and I believe every child with a seizure disorder should be on Omega-3 oils. Two of my favorites is Eskimo Kids Tutti-Fruiti by Integrative Therapeutics and Super EFA by Seroyal/Genestra. You can learn more about these products at our online store.
If you choose to try some of these products, don't forget to discuss it with your HealthCare Provider.
References:
FDA Advisory Members Agree Antiepileptics Pose Suicidality Risk, Nix Need for Black-Box Warning. July 2008 Medscape
