Improved Access to Adverse Drug Event Reports

Searching for information on adverse drug reactions has never been easier.

The US Food and Drug Administration (FDA) has launched a new search tool that makes accessing data on adverse events easier. This new tool utilizes the FDA’s Adverse Event Reporting System (FAERS). The tool was designed to make it easy for consumers, health care providers and researchers to access this important information.

The tool allows users to search for and organize data by drug or biological product, age of the patient, type of adverse event and the year the adverse event occurred. Users can even search within a specific time frame.

"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," said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a press release.

The FDA uses FAERS to look for new safety concerns that might be related to a marketed product.

The agency noted that there may be some limitations to these data. Just because the FAERS contains reports on adverse drug events does not mean the drug or biologic product caused the adverse event. In addition, the data on its own does not indicate the safety profile of the drug or biologic product.

The FDA recommended that patients speak with their health care providers if they have any concerns about the medications they take.

To report adverse drug events, complete and submit an online report to the FDA's MedWatch Adverse Event Reporting program or download and fax the completed form to 1-800-FDA-0178.

Written By Anyssa Garza, PharmD, BCMAS