On September 28, 2017, the FDA released a new search tool that allows patients, doctors, and others to see the adverse events reported for a particular drug or medical device by searching the product name, patient age, adverse event type and date, or timeframe in which an event occurred.
This tool is referred to as the FDA Adverse Events Reporting System (FAERS) Public Dashboard.
Information not provided by this new search tool includes individual case report narratives. However, these narratives may be accessed through a Freedom of Information Act (FOIA) request.
FDA Commissioner Scott Gottlieb, M.D. describes the motivation for creating such a tool in the September 28, 2017 press release:
Tools like the FDA Adverse Event Reporting System are critical to the FDA’s ability to help ensure the greatest level of transparency and help patients and providers make safe use of drug and biologic products after they are approved by the FDA…The FDA is committed to fully informing patients and providers of adverse events reported with medical products and this enhanced portal now provides patients, doctors and others with easier access to the data they are interested in.
The FDA also hopes that this new tool will prompt the submission of more detailed and complete reports of adverse events by fostering a better understanding of the reported data.
While this tool will undoubtedly be helpful for patients who want to learn more information about the drugs they are prescribed, the FDA is careful to provide the following disclaimer:
While the FAERS dashboard now offers stakeholders many more ways of searching for and organizing data on adverse events reported to the FDA for many drug and biologic products, there remain limitations to the data. For example, while FAERS contains reports on adverse events associated with a particular drug or biologic, this does not mean that the drug or biologic caused the adverse event. Importantly, the FAERS data by themselves are not an indicator of the safety profile of the drug or biologic. Patients should still talk to their health care professional if they have any concerns regarding their medications.
Another limitation of the new search tool is the potential for duplicate, incomplete, or inaccurate reports.
Regardless, this new searchable dashboard makes important information more accessible, and will most likely help many patients make more informed decisions when it comes to their healthcare.
From a drug injury law standpoint, this tool also may prove to be a valuable resource for patients who believe that a drug may have caused significant harm to their health, or the health of someone they know–even though the FDA is careful to point out that such reports do not indicate causation.
If you or someone you know has suffered an adverse effect due to a brand-name prescription drug, we encourage you to submit a Drug Injury Law Case Review – it is free, confidential, and there is no obligation.
Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
Drug Injury Watch: Side Effects News & Reports
Drug Injury Law: Medical & Legal Information