Potential Safety Signals and Their Significance—Reply

In reply

We commend Dr Woo for highlighting additional processes used by the US Food and Drug Administration (FDA) to monitor and disseminate postmarketing drug safety information in accordance with the Food and Drug Administration Amendments Act. Also, we commend the commentaries of Wolf¹ and Dal Pan and Temple.² They highlight the importance of our study³ along with the importance of potential signals of serious risks identified through the Adverse Event Reporting System (AERS). We echo the concerns of Dal Pan and Temple,² as there may be no easy solution for identified potential safety signals since evidence of a true signal is limited. Despite the limited evidence of a true signal, we firmly believe that health care professionals and the public should continue to monitor these reports from the FDA and choose alternative therapies when applicable if serious potential risks are present. Overall, we are in support of the comments by Wolf.¹