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From the Departments of Neurology, Pediatrics, Pharmacy, and Pharmaceutics (Dr. Pellock), Virginia Commonwealth University, Medical College of Virginia, Richmond; and Departments of Neurology, Pediatrics, and the Comprehensive Epilepsy Management Center (Dr. Shinnar), Montefiore Medical Center and the Albert Einstein College of Medicine, Bronx, NY.
Address correspondence and reprint requests to Dr. John M. Pellock, Division of Child Neurology, Virginia Commonwealth University, PO Box 980211, Childrens Pavilion, First Floor, Richmond, VA 23298-0211; e-mail: jpellock{at}hsc.vcu.edu
The authors reviewed respiratory adverse events and deaths spontaneously reported to Xcel Pharmaceuticals associated with diazepam rectal gel. Over 2 million doses have been prescribed. The authors identified nine respiratory adverse events and three deaths. The respiratory events associated with prolonged seizures had a good outcome. The deaths occurred in the context of a prolonged seizure and respiratory depression was not the main symptom. When used as recommended, diazepam rectal gel has a low rate of serious morbidity or mortality.
Funded by Xcel Pharmaceuticals.
Drs. Pellock and Shinnar are consultants to Xcel Pharmaceuticals, the manufacturer of Diastat, and received personal compensation to review the adverse events of rectal diazepam gel registered through MedWatch, analyze the data, and prepare the manuscript. Drs. Pellock and Shinnar have received grants and honoraria in excess of $10,000 from Xcel Pharmaceuticals.
Received June 28, 2004. Accepted in final form January 27, 2005.
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