FDA Launches New Adverse Event Look-Up Tool

WHY IT MATTERS

Patients with rare diseases can now directly search for safety reports on their specific medications and medical devices without waiting for their doctor to look it up, helping them make more informed decisions about their treatment.

The FDA created a new online tool called the FDA Adverse Event Monitoring System (AEMS) that makes it easier for people to look up safety reports about medicines and medical devices. This tool brings together information from different FDA databases into one place so patients and doctors can see what side effects or problems have been reported. The FDA says this is an important step toward being more transparent and honest about drug and device safety.

FDA launched a new unified platform for analyzing adverse event reports. This platform — called the FDA Adverse Event Monitoring System (AEMS) — represents a major achievement in the agency’s mission to modernize and provide radical transparency into the safety of regulated products.