What are adverse drug events?

Drug Policy Question of the Week – 6-5-11

As answered by Mary Jane Borden, Editor of Drug War Facts for the Drug Truth Network on 6-5-11. http://www.drugtruth.net/cms/node/3413

Question of the Week: What are adverse drug events?

An article in the Connecticut Law Review defines the U.S. Food and Drug Administration (FDA) as the agency that

“regulates both the safety and effectiveness of prescription pharmaceuticals and certain medical devices. In addition to ensuring that prescription drugs are safe and effective before they are sold in interstate commerce, the FDA approves all information a manufacturer plans to provide physicians on a drug’s recommended use, contraindications, risks, and side-effects.”

The FDA’s Center for Drug Evaluation and Research (CDER) is the regulatory body that oversees over-the-counter and prescription drugs, and biological therapeutics. This agency has produced several trendable reports, including a data briefing covering 1996 to 2006.

This paper overviews the CDER’s Adverse Event Reporting System that compiles

“voluntary adverse drug reaction reports from [healthcare practitioners] and required reports from manufacturers … this system forms “the basis of “signals” that there may be a potential for serious and unrecognized drug-associated events [or reactions].”

Drug reaction numbers from this FDA system are now displayed in two Drug War Facts Tables, one called “Prescription Drug Product Approvals, Recalls and Adverse Event Reports” and the other named “AERS Patient Outcomes by Year,” both sourced directly from the FDA.

Both of these tables reflect troubling statistics. The former table shows that Adverse Drug Event reports to the FDA concerning prescription drugs soared by almost +75% for the six years (2002-2007) compared to the prior six years (1996-2001). Further, and perhaps more disturbing, adverse reaction outcome “deaths” totaling over 370,000 and “serious outcomes” eclipsing 2,300,000 occurred during the ten years from 2000 to 2009 for the prescription drugs tracked by this FDA system.

These facts and others like them can be found in the Regulation of Prescription Drugs section of the United States chapter of Drug War Facts at www.drugwarfacts.org.