Assessments - Information for Patients and Consumers
- The information contained on this website is provided as part of FDA's commitment to place knowledge acquired from the Sentinel System in the public domain as soon as possible.
- Much of the content on this site is technical and intended for use by scientists in various areas of expertise.
- The fact that FDA requests and receives data on a particular product through Sentinel does not necessarily mean there is a safety issue with the product.
- FDA may access the data available through Sentinel for a variety of reasons beyond assessing potential safety risks for a specific product. Some examples include determining a rate or count of an identified health outcome of interest, examining medical product use, or seeking to better understand the capabilities of the Sentinel System.
- When evaluating a potential safety issue, FDA scientists consider the data obtained through Sentinel with information from various other data sources, such as adverse event reports, published study results, and clinical trials, to help make the most informed decisions possible.
- FDA communicates its interpretation of Sentinel activities through existing channels, such as FDA's press announcements, MedWatch Alerts , and Drug Safety Communications, rather than on this website.
- Information from this site should not affect your use of a medical product in any way. Patients who have questions about the use of a medical product should contact their health care professional.
Assessments - Information for Industry
The information contained on this website is provided as part of FDA's commitment to place knowledge acquired from Sentinel in the public domain as soon as possible. To most effectively interpret results from observational studies, it is important to consider not only the studies that supported a hypothesis, but also the studies that did not. The website serves as a public data repository that archives all the activities of Sentinel and provides important context to those seeking to understand the significance of any specific activity. This information is being provided to the public in the interest of transparency and for purposes of demonstrating the extent of use and the various ways FDA is utilizing the Sentinel System. While the data posted here may contribute to important overall conclusions, FDA relies on other mechanisms for communicating such conclusions to the public.
When reviewing this information please be aware that there are times when FDA may access the data available through Sentinel for a variety of reasons beyond seeking direct access to information that can help assess potential safety risks for a specific product. Some examples include determining a rate or count of an identified health outcome of interest, examining medical product use, exploring the feasibility of future, more detailed analyses within Sentinel, and seeking to better understand the capabilities of the Sentinel System.
Data obtained through Mini-Sentinel are intended to complement other types of data and information compiled by FDA scientists, such as adverse event reports, published study results, and clinical trials, which can be combined with Mini-Sentinel data and used by FDA to inform regulatory decisions regarding medical product safety. However, data obtained from the Min-Sentinel System are not necessarily used by FDA to take regulatory actions or to make safety decisions. Any public health actions taken by FDA regarding products involved in Mini-Sentinel queries and protocols are communicated through existing channels.
FDA also wants to emphasize that the fact that the Agency may access data and report findings from the Mini-Sentinel System for a number of reasons. Such activity does not necessarily lead to an Agency recommendation regarding the use of the drug. Patients who have questions about the use of an identified medical product should contact their health care professional.
The information provided on this website is intended to inform the public about the Mini-Sentinel pilot. Responsibility for the content of this website lies with the Mini-Sentinel Coordinating Center (MSCC).
This website has links to many others. You should be aware that:
- The MSCC cannot attest to the accuracy of information provided by external links.
- Linking to an external site does not constitute an endorsement by the MSCC, or any of its employees, of the sponsors of that website or the information and products presented on that site.