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FDA announces improvements to Adverse Event Reporting System




The US Food and Drug Administration (FDA) has announced improvements to its Adverse Event Reporting System (FAERS). The system is a database of reported medication issues, including product quality complaints leading to adverse events, medication error reports and other adverse event reports. 

A new online dashboard has been unveiled by the FDA. It claims this will make the FAERS database more easily accessible for patients and healthcare professionals. An updated system is an important tool in helping "inform the agency of possible problems associated with a product," according to FDA Commissioner Scott Gottlieb, MD.

He explained the database is a useful surveillance tool for the FDA, making it easier to identify safety concerns related to products already available on the market. However, he noted there are still limitations to the data. "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," Gottlieb stated. 

Another limitation of the data is that information in the reports have not been verified, so submission does not necessarily mean the symptoms or issues experienced are caused by the medication in question. Furthermore, the data does not provide accurate information about the frequency with which adverse events are experiences and whether patients experience recurrent reactions. Data from FAERS is not, in itself, an indicator of the safety profile of a drug or biologic. Patients with concerns about their medication and adverse effects were advised to discuss the issues with their healthcare professional.

On October 12th, the FAERS had logged over 14 million reports, with more than eight million of these classed as serious reports (excluding deaths). Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research commented: "By giving people a better understanding of these data, and the associated limitations, we hope the new interface will encourage people to submit more complete reports."

Adverse Event Reports can be submitted electronically or by printing a form and faxing it to fax at 1-800-FDA-0178. Reports are accepted from both patients and healthcare professionals and can be filled in online here.