Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS) (formerly AERS)
- What is FDA Posting?
- Why is FDA posting this information?
- How was the list generated?
- What information is provided?
- Quarterly Reports
FDA wants to emphasize that the listing of a drug and a potential signal of a serious risk/new safety information on this Web site does not mean that FDA has determined that the drug has the risk. FDA is not suggesting that healthcare providers should not prescribe the drug or that patients taking the drug should stop taking the medication while evaluation of the potential safety issue is being conducted. Patients who have questions about their use of the identified drug should contact their health care provider.
FDA will complete its evaluation of each potential safety issue and may issue additional public communications as appropriate.
see insert). FDA will publish a new list of potential signals of serious risks/new safety information identified each quarter.
A new report will be made available each quarter showing newly identified potential signals of serious risks/new safety information identified from the FAERS database during the previous quarter. Information from previous quarters with updates will remain available on the website until an FDA regulatory action has been taken. FDA actions may include a determination either that a) the drug is not associated with the risk and therefore no regulatory action is required, or b) the drug may be associated with the risk, and one of the following is required: a modification to the product labeling; development of a REMS; marketing suspension or withdrawal; or gathering additional data to characterize the risk.