The FDA said this week it launched a new search tool for its adverse event reporting system dashboard to allow users to access reports of adverse drug reactions.
FDA Commissioner Dr. Scott Gottlieb said the changes are intended to “better inform patients and health care professionals of adverse events reported with drug and biologic products.”
“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,” Gottlieb said in an FDA release.
The agency said that while the FAERS database is a valuable tool, it is only one of many data sets that it uses to assess possible problems associated with products.
Late last week, the FDA warned physicians about the risk for a dangerous type of leak with endovascular stent grafts used to wall off aneurysms in the abdominal aorta.