FDA enhances the access to reports of adverse drug reactions
Food and Drug Administration (FDA) has recently started a new search tool called the FDA’s Adverse Event Reporting System (FAERS) which insures a free access to information on adverse events associated with using medicines and biologic products.
FDA Commissioner Scott Gottlieb, M.D claimed: «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 the 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.»
This brand-new search tool allows users to filter the data not only by the name of the drug (biological product) but also by patient’s age, sort of adverse event, year the adverse event happened (or a user can custom date range himself). FDA believes that making the process of reporting adverse events easier for consumers will help to improve transparency of drugs safety information and get more detailed reports.
Another application of FAERS is using it for pharmacovigilance purposes, for monitoring any new safety concerns that may be associated with approved products and assessing drugs’ manufacturer’s compliance with existing regulations. All reports submitted in FAERS are reviewed by clinical experts in the FDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research.
The FDA strongly recommends doctors and patients to report all adverse events or quality issues they faced while using a drug and biologic products.