Table 3.

Applying FDA criteria to 41 reports in this study

FDA criteria for evaluating postmarketing safety concerns	Applicability to FAERS reports of inappropriate schedule of product administration
Temporal association (i.e., the drug was taken before the adverse event occurred)	Clearly identified to have a temporal association
Coherence with existing information or biological plausibility	The events reported (e.g., CNS depression, respiratory depression, altered mental status) correspond with known GHB effects
Similar effect in drugs of the same class	Other CNS depressants taken in excessive amounts would be expected to cause similar reactions
Dose-response relationship	These events are directly tied to excessive doses of GHB in a specified time period
Consistency of the association (replicability of the results)	41 reports of this similar type have been reported
Specificity of the association	Case narratives are highly specific to the effect of dosing <2.5 h after the first dose and the adverse event(s)

CNS central nervous system, FAERS United States Food and Drug Administration Adverse Event Reporting System, FDA US Food and Drug Administration, GHB γ-hydroxybutyrate