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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a case study, an 11-month-old boy and a 14-month-old girl were described, who died of acute intoxication following an accidental exposure to fentanyl [not all routes stated; dosages and time to reactions onsets not stated].
Case 1: An 11-month-old boy was found unresponsive without suspicion of drug use or foul play. Interviews of the witness suggested a potentially unsafe sleeping situation on the nearby adult mattress. Autopsy findings revealed no evidence of pre-existing natural disease, congenital anomaly or remote injuries. A facial abrasion along with pulmonary congestion was noted. Sudden unexplained infant death syndrome potentially associated with an unsafe sleeping situation was suspected. Biological specimens and gastric contents were collected for toxicology...
- DeRienz RT, et al. Child Fatalities Due to Heroin/Fentanyl Exposure: What the Case History Missed. Journal of Analytical Toxicology 42: 581-585, No. 8, Oct 2018. Available from: URL: http://doi.org/10.1093/jat/bky052 - USA