FDA uses the Sentinel System to conduct active surveillance of the products it regulates. It does this to track the safety and performance of medical products. FDA conducts safety assessments in ARIA for the following purposes, as described in Section 505(o)(3)(B):
- Assess a known serious risk related to the use of the drug
- Assess signals of serious risk related to the use of the drug
- Identify an unexpected serious risk
After finishing the analysis, FDA posts results and details in Completed ARIA Assessments & Impact. The data from Sentinel complements other types of evidence such as adverse event reports, observational studies, and clinical trials.
The appearance of a drug on this page does not mean that FDA has concluded that the drug has the listed risk. Rather, these drugs have a potential safety issue requiring further study. It also does not mean that FDA has identified a causal relationship between the drug and the listed risk, nor is FDA suggesting that healthcare providers should not prescribe the drug. Patients taking these drugs who have questions should contact their healthcare provider.
Want to learn more about the drugs that are being evaluated in Sentinel? Find details and resources in the links below.