The FDA is trying harder to keep us safe from adverse events from new medications. As this article from MedAdNews points out:
Calls for evidence-based medicine have led physicians and consumers to re-examine the risks versus benefits of existing medications. Many medications have been scientifically tested among a predominantly adult Caucasian population, with less evidence for medication safety and efficacy among specific ethnic/racial groups, women, and pediatric patients.
Complete article from MedAdNews.