Date of Award

9-27-2010

Document Type

Open Access Thesis

Degree Name

Medical Doctor (MD)

First Advisor

Paul Barash, MD

Second Advisor

Loreta Grecu, MD

Abstract

THE FDA BLACK BOX WARNING SYSTEM: THE UTMOST IN DRUG AND PATIENT SAFETY? Andrew Georgi (Sponsored by Paul Barash, MD, and Loreta Grecu, MD). Department of Anesthesiology, Yale University School of Medicine, New Haven, CT. Of the 7856 pharmaceutical products under the purview of the Food and Drug Administration (FDA), over six hundred have a black box warning (BBW). As the FDAs highest level of warning included on drug package inserts, this notation is reserved for those drugs that pose significant risks leading to death or serious injury. However, the types of warnings that warrant this distinction have not been clearly identified and are not always readily justifiable. In addition, great variability exists among the drugs resources charged with transmitting this critical information to healthcare professionals and the public. The objective of this paper is to establish the most comprehensive list of drugs with a BBW, classify their content according to organ systems, and in doing so evaluate the consistency of information presented by these widely-used drug resources. This was accomplished by cross-referencing and analyzing the drug BBW information from four resources: DailyMed, Micromedex, Facts & Comparisons, and BlackBoxRx. Six hundred and thirty-five drug/drug combinations were identified as having a BBW. The most frequently affected organ systems were cardiovascular and pulmonary with 200/635 and 144/635 drug BBWs, respectively. DailyMed was the most comprehensive list with 551/635 drugs, still a shortfall of 13%. The four lists were in complete agreement for 416/635 (65%) of the drugs listed. This highlights the FDAs need to review the black box warning system and determine how best to communicate this drug information accurately and efficiently to the healthcare community.

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