User-Friendly Adverse Events Reporting System Now Available

The U.S. Food and Drug Administration (FDA) launched the FDA Adverse Event Reporting System (FAERS): Public Dashboard, a user-friendly search tool that improves access to data on adverse events (AEs) associated with drug and biologic products.

The new dashboard allows users to search for and organize data by criteria such as drug/biologic product, patient age, type of AE, and year AE occurred. In addition to easing consumer access to the data, the FDA said it hopes the increased transparency will spur the submission of more detailed and complete reports from consumers, health-care professionals, and others.

“[We] spend a lot of time looking at FAERS reports received regarding approved drug and biologic products, and these reports can be very valuable components of our safety assessments,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “By giving people a better understanding of these data, and the associated limitations, we hope the new interface will encourage people to submit more complete reports.”

Source: U.S. Food and Drug Administration press release, September 28, 2017.