|Source||U.S. Food and Drug Administration|
|File Size||1-2 GB per year|
|Dates Covered||1998-First two quarters of 2012 (contact NICAR for archived files from 1969-1997)|
|Buy this database||Click here to purchase and download this database|
The FDA relies on the Adverse Event Reporting system to flag safety issues and identify pharmaceuticals or therapeutic biological products (such as blood products), for further epidemiological study. It may ultimately prompt regulatory responses such as drug labeling changes, letters to health care professionals, or market withdrawals.
The agency requires product manufacturers and distributors to report adverse events regularly in accordance with 21 CFR 310.305 and 314.80. Mandatory reports for drugs in clinical trials and newly marketed drugs are submitted in various forms: 15-day alerts, quarterly or annual updates. The MedWatch program also collects voluntary reports from health care professionals and consumers. Adverse drug experiences include any serious and unexpected consequences of human drug use in a medical practice - such as failure of "expected pharmacological action," as well as accidental or intentional overdoses or abuse.
AERS replaced the Spontaneous Reporting System in October 1997. The FDA estimates that 118 reports for 1997-98 are included in the old SRS data. The AERS collection begins with the fourth quarter of 1997 and is complete through December 2006. Emphasis on reporting and efficiency of collecting reports have fluctuated, as seen by the relatively small number of records for the earlier years in this dataset and the incomplete entries throughout.
The AERS format attempts to improve and standardize the same basic information fields collected in SRS. The most notable difference between the two sets is a Comments table containing detailed memo fields; it only exists for SRS data 1993-1998.
Record layouts and samples of this database
|Data sample (demo07.xls)||33.2 KB|
|Record layout (Layout.xls)||22.5 KB|
|Main documentation (READFIRST.txt)||17.1 KB|
Drug data: Key data sources on prescription drug sales and marketing
Adams lists sources of pharmaceutical data that include the National Ambulatory Medical Care Survey as well as data from the FDA. The background, data description and pitfalls are described for each dataset.
Probing the Pharmaceutical Industry
Tips on how to find websites dealing with pharmaceuticals.
Internet Resources and Public Records
Provides a listing of websites for information about drug trials; lists sites to help track money, survivors and doctors; Includes reference points to use in accountability; Lists other databases available on the FDA website that are helpful
A CBS News investigation into the FDA reveals that the organization has approved a number of drugs despite objections from its own scientists. Among the questionably approved drugs was Rezulin, a diabetes drug, and Relenza, a flu drug. "The series exposed a serious rift between FDA rank-and-file scientists who felt their concerns were being ignored, and FDA executives who repeatedly sided with pharmaceutical companies over issues of safety regarding controversial drugs."