No conflict of interest was declared.
FDA drug prescribing warnings: is the black box half empty or half full?†
Version of Record online: 18 NOV 2005
Copyright © 2005 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 15, Issue 6, pages 369–386, June 2006
How to Cite
Wagner, A. K., Chan, K. A., Dashevsky, I., Raebel, M. A., Andrade, S. E., Lafata, J. E., Davis, R. L., Gurwitz, J. H., Soumerai, S. B. and Platt, R. (2006), FDA drug prescribing warnings: is the black box half empty or half full?. Pharmacoepidem. Drug Safe., 15: 369–386. doi: 10.1002/pds.1193
- Issue online: 1 JUN 2006
- Version of Record online: 18 NOV 2005
- Manuscript Accepted: 6 JUN 2005
- Manuscript Revised: 5 JUN 2005
- Manuscript Received: 15 FEB 2005
- The Agency for Healthcare Research and Quality (AHRQ). Grant Number: cooperative agreement U18 HS 11832
- black box warnings;
- drug labeling;
- Food and Drug Administration;
- prescribing safety;
- regulatory actions;
- risk communication
Black box warnings (BBWs) are the Food and Drug Administration's (FDA) strongest labeling requirements for high-risk medicines. It is unknown how frequently physicians prescribe BBW drugs and whether they do so in compliance with the warnings. The purpose of the present study was to assess the frequency of use of BBW medications in ambulatory care and prescribing compliance with BBW recommendations.
This retrospective study used automated claims data of 929 958 enrollees in 10 geographically diverse health plans in the United States to estimate frequency of use in ambulatory care of 216 BBW drugs/drug groups between 1/1/99 and 31/6/01. We assessed dispensing compliance with the BBW requirements for selected drugs.
During a 30-month period, more than 40% of enrollees received at least one medication that carried a BBW that could potentially apply to them. We found few instances of prescribing during pregnancy of BBW drugs absolutely contra-indicated in pregnancy. There was almost no co-prescribing of contra-indicated drugs with the two QT-interval-prolonging BBW drugs evaluated. Most non-compliance occurred with recommendations for baseline laboratory monitoring (49.6% of all therapy initiations that should have been accompanied by baseline laboratory monitoring were not).
Many individuals receive drugs considered to carry the potential for serious risk. For some of these drugs, use is largely consistent with their BBW, while for others it is not. Since it will not be possible to avoid certain drug- associated risks, it will be important to develop effective methods to use BBWs and other methods to minimize risks. Copyright © 2005 John Wiley & Sons, Ltd.