From Wikipedia,
the free encyclopedia
In the
United States, a black box
warning is a type of warning
that appears on
prescription drugs that may
cause serious
adverse effects. It is so
named for the black border that
usually surrounds the text of the
warning.
A black box warning means that
medical studies indicate that the
drug carries a significant risk of
serious or even life-threatening
adverse effects. The U.S.
Food and Drug Administration
(FDA) can require a
pharmaceutical company to
place a black box warning on the
labeling of a
prescription drug, or in
literature describing it. It is
the strongest warning that the FDA
requires.
Black box warnings on drugs
have received increased media
attention in the United States in
2005. Among some of the more
widely covered stories:
- The FDA has required that
black box warnings be placed on
all
antidepressant medications
warning they may result in
increased risk of
suicidal tendencies in
children and
adolescents.
- FDA advisors have
recommended that
Pfizer be required to place
a black box warning on their
NSAID
celecoxib (Celebrex®).
- As of 17 November 2004, the
FDA has required a black box
warning on the
Depo-Provera contraceptive
injection, due to the risk of
significant loss of bone density
with long-term use.
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