FDA Offers Better Access to Adverse Drug Reports

The new dashboard allows users to search for and organize data by criteria such as drug/biological product, age of the patient, type of adverse event, year the adverse event occurred, or within a specific timeframe.

The U.S. Food and Drug Administration this week launched a user-friendly search tool that improves access to data on adverse events associated with drugs and biologic products through its Adverse Event Reporting System (FAERS). The tool is designed to make it easier for consumers, providers, and researchers to access the information.

"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," said FDA Commissioner Dr. Scott Gottlieb. "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."

The new dashboard allows users to search for and organize data by criteria such as drug/biological product, age of the patient, type of adverse event, year the adverse event occurred, or within a specific timeframe.

FDA uses FAERS for surveillance, such as looking for new safety concerns that might be related to a marketed product, evaluating a manufacturer's compliance with reporting regulations, and responding to outside requests for information. The reports in FAERS are evaluated by clinical reviewers in FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research to monitor the safety of products after they are marketed. If a potential safety concern is identified in FAERS, further evaluation is performed.

"Our focus on safety extends beyond approval," said Dr. Janet Woodcock, director of FDA's Center for Drug Evaluation and Research. "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."

The agency also encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of drug and biologic products to its MedWatch Adverse Event Reporting program.

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