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West Hartford, CT, June 6, 2011 – The following statement about the availability of pentobarbital, a critically important drug in the treatment of dangerous, non-stop seizures, is issued in response to media inquiries concerning the American Epilepsy Society’s perspective on halting the manufacture or limiting access to this medication.

American Epilepsy Society Position in Support of Continuing Availability of Pentobarbital in the Critical Care Management of Refractory Status Epilepticus

The American Epilepsy Society expresses great concern over the possible discontinuation in manufacturing or limited distribution of pentobarbital injection. There are several legitimate uses of pentobarbital in the context of treating epilepsy. These uses include the critical care management of refractory status epilepticus (non-stop seizures) and control of increased intracranial pressure in individuals who have experienced traumatic brain injury or other neurological event. Both of these conditions are life threatening and pentobarbital is a widely recognized standard treatment. The limited distribution or discontinuation in manufacture of pentobarbital would greatly limit the treatment options for many patients who face life-threatening situations related to seizures and epilepsy.

Status epilepticus is not a rare condition. Research indicates there are approximately 123,000 cases per year in the U.S., and up to 20% of patients with convulsive status epilepticus may die if not given prompt and aggressive treatment.1 Refractory status epilepticus poses the greatest danger. Medical experts recommend treatment with a general anesthetic when all other drugs fail,2,3,4 and the infusion of pentobarbital is considered the gold standard in the management of these prolonged cases.3

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 seizures. The American Epilepsy Society is committed to the promotion of optimal care, including access to all therapeutic options in the management of seizures. Pentobarbital must remain on the market and available to physicians without geographic limitation for the critical care management of refractory status epilepticus and treatment of other neurological events for which it may be indicated.

References:

1. DeLorenzo RJ, Hauser WA, Towne AR, et al. A prospective, population–based epidemiologic study of status epilepticus in Richmond, Virginia. Neurology 1996; 46:1029-1035.

2. Arif H, Hirsch LJ.; Treatment of Status Epilepticus; Semin Neurol, 2008 Jul: 28(3):342-54. Epub 2008 Jul 24.

3. Shearer P. Riviello J.; Generalized convulsive status epilepticus in adults and children: treatment guidelines and protocols; Emergency Medicine Clinics of North America; 2011 Feb;29(1);51-54

4. H. Meierkord,P. Boon, B. Engelsen, K. Locke, S. Shorvon, P. Tinuper, M. Holtkamp; EFNS guideline on the management of status epilepticus in adults ; European Journal of Neurology, 17:348-355, dol:10.1111/j.1468-1331.2009.02917.x