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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.
* To whom correspondence should be addressed. E-mail: jpellock{at}hsc.vcu.edu.
Abstract-- 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.
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