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.
Publication types
-
Research Support, Non-U.S. Gov't
MeSH terms
-
Administration, Rectal
-
Adult
-
Anticonvulsants / administration & dosage
-
Anticonvulsants / adverse effects
-
Anticonvulsants / pharmacokinetics
-
Child
-
Child, Preschool
-
Diazepam / administration & dosage*
-
Diazepam / adverse effects*
-
Diazepam / pharmacokinetics
-
Drug Interactions
-
Epilepsy / complications
-
Epilepsy / drug therapy*
-
Epilepsy / physiopathology
-
Gels
-
Humans
-
Infant
-
Middle Aged
-
Mortality
-
Narcotics / adverse effects
-
Respiratory Insufficiency / chemically induced*
-
Respiratory Insufficiency / mortality*
-
Respiratory Insufficiency / physiopathology
-
Retrospective Studies
Substances
-
Anticonvulsants
-
Gels
-
Narcotics
-
Diazepam