'Black Box' Drug Warning Labels Applied Inconsistently: Study 02/04/11
FRIDAY, Feb. 4 (HealthDay News) -- Safety labels that outline
concerns about medications, known as "black box warnings," are not
always consistent within drug categories, a new study suggests.
These warnings should be rendered uniform for all medications
within a single class of drugs, according to a team of researchers
from Greece and the United States. The team also advised that
supplemental warnings (for example, following a drug withdrawal)
should be added in a reasonable timeframe.
The research team published their report Feb. 2 in the
Journal of General Internal Medicine.
"Our findings imply that the process of black box warning acquisition requires transparent and systematic rules, as well as clear justification for the presence of, or lack of evidence for, specific major risks for individual drugs," the research team led by Orestis Panagiotou from the University of Ioannina's School of Medicine in Greece, said in a journal news release.
The authors pointed out that black box warnings are the
strongest tool the U.S Food and Drug Administration has to issue
consumer safety warnings and outline drug risks. Most warnings are
issued per class of drugs, rather than for an individual drug,
because concerning side effects usually apply broadly to a type of
drug rather than to a single medication.
Therefore, the team focused on analyzing black box warning
labels placed on drugs that all fell within the same drug
The investigators examined 20 different drug classes that in
total covered 176 medications, all chosen from data included in the
USA's "Top 200 Drugs for 2008 by Sales" report.
Half of the 20 drug classes had at least a single black box
warning issued; the other half had no such warnings.
Black box warning inconsistencies were found in nine drug
classes, with 15 specific warnings not uniformly evident on the
labeling of all drugs that fell within each specific class.
In two-thirds of these (10 of the 15), the information was, in
fact, noted on the labels in a different place, as either a simple
warning or plain text. The rest did not include the warnings
anywhere on the label.
What's more, specific drugs subject to a withdrawal from the
market were not typically outfitted with a black box warning prior
to a withdrawal, the team found. And drugs similar to the withdrawn
medication were frequently not labeled with a relevant black box
warning referencing the concerns that led to the withdrawal in
A significant time lag in the posting of black box warnings was
also commonly observed (ranging from two months to 14 years) for
drugs that fell into classes in which similar drugs were subject to
The authors suggested that if a drug is in the same class as
another drug that requires a black box warning, but the warning
not apply to that particular medication, the warning label
should specifically explain why this is the case to ease consumer
For more information on black box warnings, visit the
U.S. Agency for Healthcare Research and
Copyright © 2011
. All rights reserved.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.