FDA drug prescribing warnings: is the black box half empty or half full?
OBJECTIVE
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.


METHODS
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.


RESULTS
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).


CONCLUSIONS
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.
Wagner
Anita K
AK
Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care, Boston, MA 02215, USA. awagner@hms.harvard.edu
Chan
K Arnold
KA
Dashevsky
Inna
I
Raebel
Marsha A
MA
Andrade
Susan E
SE
Lafata
Jennifer Elston
JE
Davis
Robert L
RL
Gurwitz
Jerry H
JH
Soumerai
Stephen B
SB
Platt
Richard
R
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000553:Ambulatory Care; D002648:Child; D002675:Child, Preschool; D004348:Drug Labeling; D004363:Drug Utilization; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D019983:Guideline Adherence; D006279:Health Maintenance Organizations; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008875:Middle Aged; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D014481:United States; D014486:United States Food and Drug Administration