Maximize Patient Safety Through the FDA’s MedWatch Program

MedWatch is a U.S. Food and Drug Administration (FDA) program for collecting reports on safety issues with drugs, biologics, medical devices, dietary supplements and cosmetics. As a first point of contact for many patients, you are uniquely positioned to observe and act on emerging safety concerns.

Program Benefits

The MedWatch program has two main purposes – to alert providers about product recalls, safety labeling changes and new risks, and to allow providers to report adverse events or quality concerns directly to the FDA. While staying up-to-date, you build patient trust and open a communication outlet to act on patient–reported adverse events. The data collected from MedWatch helps:

• Promote early awareness about medication recalls, safety labeling changes and newly identified relevant adverse events.
• Provide a reliable resource to support patient counseling.
• Support clinical decision-making by integrating real-world safety data.
• Empower you and your patients to act on patient-reported adverse events and contribute to national pharmacovigilance, identifying trends that may lead to FDA actions such as black box warnings, Risk Evaluation and Mitigation Strategies, or product withdrawals.
• Simplify safety monitoring and strengthen collaboration among health care providers in reporting and responding to drug safety concerns.

Resources

• Sign up for alerts by visiting the MedWatch: The FDA Safety Information and Adverse Event Reporting Program page.

• Submit reports via the MedWatch Online Voluntary Reporting Form for unusual side effects, suspected medication errors, product defects, packaging concerns, and patient complaints about unexpected adverse reactions.