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How To Search the FDA’s Adverse Event Databases

By Burg Simpson

November 21, 2019   Ohio Dangerous Drugs and Medical Devices

It is a sad fact that every day individuals suffer injuries while using products regulated by the FDA. When such injuries occur, consumers and medical providers can report these events to the FDA. Such reporting is important to allow FDA to analyze the safety of the products it regulates. Not many people know that the databases that hold these reports are publicly accessible and searchable. This allows ordinary consumers to look up the products they are taking to see if any adverse experiences have been reported.

Reports of injuries, sometimes called adverse event reports, are maintained in several FDA databases. They are organized by product type: drugs and human biologics, medical devices, vaccines, cosmetics, dietary supplements, and food. Below is a description of each database and some on how best to search them.


FDA Databases

Drugs & Human Biologics

The FAERS database contains adverse event reports related to drugs and biologic products (e.g., gene therapy, blood, human tissue). These reports have been submitted by the pharmaceutical industry, healthcare providers, and consumers.

Public access is available through:

–  Searchable web-based tool called the FDA Public Dashboard

–  Export and download raw data.

When searching for a specific drug on the Public Dashboard, remember that drugs have a generic name and can have multiple brand names. It can be helpful to include the drug’s generic name and other brand names in your initial search. This specific database will limit you to five drug names.


Medical Devices

The MAUDE database contains adverse event reports related to medical devices submitted by device manufacturers, healthcare providers, and consumers.

Public access is available through:

–   Searchable web-based tool

–   Export and download data sets

When using the web-based tool, it is important to be careful in your searches. Many devices have similar names. Device manufacturers also produce different versions of the same device. It is important to search for the specific device that you have. If you do not recall the specific name of your medical device, it should be in your medical records. For information on how to request your own medical records, see our previous post here.


Vaccines

The VAERS database contains adverse event reports on vaccine-related injuries submitted by healthcare providers and consumers. This database is maintained by the Center for Disease Control (CDC) and the FDA.

Public access is available through both agencies:

–  Searchable web-based tool from the CDC Wonder Database

–  Export and download of data sets through the FDA VAERS Data system.


Cosmetics, Dietary Supplements & Food

The CAERS database contains adverse event reports and product complaints related to food, dietary supplements, and cosmetics. This database can be reviewed by downloading raw data sets. A searchable, web-based tool for this database is not currently available.

These FDA databases can be useful tools in finding adverse events with drugs, medical devices, vaccines, food, cosmetics, and dietary supplements. It should be noted that there are limitations to this data. Reports in these databases are not necessarily reviewed by medical professionals. Additionally, the existence of a report does not establish a cause-and-effect relationship.

If you suspect that you or your loved one has been harmed by any of the consumer products mentioned above, contact one of Burg Simpson’s experienced product liability attorneys in Cincinnati today. Our award-winning lawyers have spent years holding manufacturers liable for the harm they have cause and can help you too. Call (513) 852-5600 or fill out our contact form for a FREE no-obligation consultation today.

 

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