FDA Announces Tool To Make Searching For Adverse Drug Events Easier

Federal drug regulators have made changes to the adverse event reporting system, which are designed to allow the public to more easily search for data on side effects, injuries and deaths linked to medications and biologic products. 

The FDA announced the launch of a “dashboard” for the agency’s Adverse Event Reporting System (FAERS) in a press release on September 28. The new dashboard allows searching by product, patient age, type of injury, or in a specific date range.

“Tools like the FDA Adverse Event Reporting System are critical to the FDA’s ability to help ensure the greatest level of transparency and help patients and providers make safe use of drug and biologic products after they are approved by the FDA,” FDA Commissioner Dr. Scott Gottlieb said in the press release. “The FDA is committed to fully informing patients and providers of adverse events reported with medical products and this enhanced portal now provides patients, doctors and others with easier access to the data they are interested in.”

Both the FDA and outside observers, like the Institute for Safe Medication Practices, use FAERS to look for possible safety concerns regarding drugs, biologics and medical devices. Doctors, patients or the manufacturers themselves are encouraged to submit a report any time they believe an adverse event, such as an injury or death, or product defect, was linked to a particular drug or device.

The system, while considered a good indicator of problems, is not perfect. First, experts estimate only about one in ten adverse events are actually reported. They also often lack crucial information that can help determine the cause of the adverse event. In the announcement, the FDA warns that just because an event was filed associated with a particular product, it does not mean that product caused the event.

“Our focus on safety extends beyond approval,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in the press release. “In fact, our staff spends 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. 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.”