CDER Reports 14 Percent Increase in Adverse Event Reports for 2004

March 21, 2005

The number of adverse event reports submitted to the FDA's Center for Drug Evaluation and Research (CDER) increased nearly 14 percent in 2004, according to a preliminary estimate from the agency.

The center received approximately 422,500 adverse event reports last year, compared to roughly 370,900 in 2003, an FDA spokeswoman said. The 2004 number is a preliminary estimate, but the agency doesn't expect the number to change when it releases its final report within the next few months. Last year, CDER released its final adverse event figures in late May.

The 2004 increase represented the fourth consecutive year in which the number of adverse event reports submitted to CDER has risen. Over the last decade, drug-related adverse event reports have nearly tripled, growing from approximately 156,000 in 1995 to nearly 425,000 in 2004.

To view the FDA's latest adverse event data, go to http://www.fda.gov/cder/aers/extract.htm (http://www.fda.gov/cder/aers/extract.htm).