In a recent issue of the British Medical Journal, two journalists criticized the US Federal Drug Administration on it's lax oversight of safety of approved medical devices. The example cited by the article was the high rate of sudden unexpected deaths in epilepsy that have occurred since the approval of the vagus nerve stimulator. The conclusions outlined by the authors may be misleading in that interpreting SUDEP rates post approval of a device is difficult at best given that there is a small but real risk of SUDEP in patients with uncontrolled epilepsy. We at the Epilepsy Therapy Project agree with our colleagues at the American Epilepsy Society in their statement issued today that clearly more research and public awareness is needed on SUDEP. For more information, please see the link below and the statement from the American Epilepsy Society.

• http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/23119

The American Epilepsy Society issued the following statement:

Concerning SUDEP and Vagus Nerve Stimulation (VNS) Therapy

A recent article in the British Medical Journal questioned the FDA's ability to monitor for serious adverse events related to the use of medical devices. The BMJ article used the Vagus Nerve Stumulator (VNS), a device used to treat medication-resistant seizures, as an example.

The article highlighted the fact that, at the time of FDA approval of the VNS, safety questions arose related to the occurrence of sudden unexpected death (also known as Sudden Unexpected Death in Epilepsy, or SUDEP). The clinical trials used to approve the VNS compared high dose vs. low dose stimulation, so there was no comparison group who did not receive the device.

It is known that patients with epilepsy have a slightly increased risk of sudden death compared to the general population, although this risk is small. Thus, interpreting the rates of SUDEP in patients who have received the device after its approval is difficult. More research is necessary to understand SUDEP and other causes of death, and more research is necessary to understand long term effects of vagus nerve stimulation, as suggested by this article.

Cyberonics Confirms Safety and Efficacy of VNS Therapy