2.3 million ADE Case Reports Involving Approximately 6000 Prescription Drugs

In a recent edition of the Archives of Internal Medicine (Arch Intern Med.2005;165:1363-1369) two researchers from the FDA’s Office of Drug Safety analyzed all reports of known and suspected adverse drug reactions submitted to the FDA’s Adverse Event Reporting System database during the period 1969 — when this adverse drug event (ADE) database was established by the FDA — through December 2002.  Their stated purpose in so doing was to find all market withdrawals, or drug recalls, as well as restricted drug distribution programs for prescription drugs approved for use in the U.S., and then determine how many of these recalls or restrictions were based on drug-safety concerns.

These FDA researchers found about 2.3 million ADE case reports involving approximately 6000 prescription drugs were made to the FDA’s Adverse Event Reporting System database during this 33-year period (1969 through 2002).

In more detail, Diane K. Wysowski, PhD, and Lynette Swartz, MEd, MBA, the two FDA researchers who wrote this recent medical journal article, reported the following findings:

During this period, numerous drug reactions have been identified and added to the product labeling as boxed warnings, warnings, precautions, contraindications, and adverse reactions. More than 75 drugs/drug products have been removed from the market due to safety problems. In addition, 11 drugs have special requirements for prescriptions or have restricted distribution programs. Drugs withdrawn or restricted represent a small proportion (about 1%) of marketed drugs.

Significantly, in this medical journal article, these FDA researchers encouraged health care professionals — especially doctors and pharmacists — as well as patients and their families to to report to the FDA directly, and/or to the respective drug manufacturer, all known and suspected serious adverse drug reactions, or ADE’s.  This point is emphasized by the researchers because, as they point out, the Adverse Event Reporting System is the FDA’s primary surveillance database used for the identification of emerging drug-safety issues.

(Posted by: Tom Lamb)