Sunday, March 27, 2011

The Number of Adverse Event Reports filed into the FDA's AERS / MedWatch Program Rose 45% Quarter over Quarter


The most recent release of Adverse Event Data from FDA's AERS / MedWatch database[1][2] shows the biggest jump in total number of reports submitted ever (if you count by absolute number of reports submitted). It's also one of the biggest percent increases (44.8%) in Adverse Event submissions since the AERS program began. I wish I knew what caused the jump. It's safe to assume that it was unrelated to the Supreme Court's recent ruling [pdf] about Adverse Event reporting related to Zicam as the jump we see in AERS reports took place from July to September of 2010, even before the case was argued before SCOTUS.