Antiemetic Drugs During Pregnancy: What Can We Learn From Spontaneous Reporting System Database Analyses? —Reply

In Reply Recognizing that preapproval randomized clinical trials typically exclude pregnant individuals and that the evidence on pregnancy safety required for drug labels must come from postapproval studies, Mazhar et al make the case for spontaneous reporting system databases, such as the US Food and Drug Administration Adverse Event Reporting System, as a highly valuable source of information about a drug ’s safety and efficacy profile, particularly in frail populations.
Source: JAMA Pediatrics - Category: Pediatrics Source Type: research