Page 13 - Public Citizen News November-December 2013

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November/December 2013
13
Public Citizen News
FDA Adds
Black Box
Warning to
Tigecycline
By Barbara Holzer
After sitting for two years on a
Public Citizen petition calling for
the addition of a black box warn-
ing to the label of the risky anti-
biotic tigecycline, the Food and
Drug Administration (FDA) final-
ly agreed with the organization’s
Health Research Group. On Sept.
27, the agency announced that
this antibiotic — approved for
use intravenously to treat a wide
range of serious infections and
sold by Pfizer under the brand
name Tygacil — would now have
to carry a black box warning,
the strongest measure the FDA
can take short of banning a drug
altogether.
“It’s troubling that the agency
took so long to require the crucial
black box warning for this antibi-
otic, particularly since it already
had discovered the 30 percent
increased mortality risk of tige-
cycline relative to that seen with
other antibiotics,” said Dr. Mi-
chael Carome, director of Public
Citizen’s Health Research Group.
“That critical information was
needlessly downplayed for three
years, along with the fact that the
FDA knew the drug had a higher
rate of failure compared to other
antibiotics when it came to the
business of actually curing seri-
ous infections. Since most infec-
tions for which tigecycline is ap-
proved can be treated with other
antibiotics, tigecycline should be
used only as a last resort.”
While Public Citizen welcomed
the news for this antibiotic, the
FDA failed to include one of the
warnings that the organization
had asked for in its 2011 petition.
“We had also called on the FDA
to include a statement within the
black box warning advising that
tigecycline should be used only
in combination with one or more
bactericidal antibiotics, which
directly kill bacteria, rather
than just interfere with bacteria
growth as is the case with bacte-
riostatic antibiotics like tigecy-
cline,” Carome said.
The FDA approved tigecycline
in 2005, but only for the treat-
ment of complicated skin infec-
tions and intra-abdominal infec-
tions such as peritonitis.
In 2009, the approval was ex-
panded to include community-
acquired pneumonia. For any of
these infections, the new FDA-re-
quired black box warning speci-
fies that tigecycline should be re-
served for use in situations when
alternative treatments are not
suitable.
The agency had become aware
that therewas an increased risk of
death with tigecycline relative to
other antibiotics by 2010. Rather
than respond to the new informa-
tion about life-threatening risks
with the kind of urgency only a
black box warning can command,
the FDA chose to take a halfway
measure.
It alerted health care profes-
sionals to the danger and asked
Pfizer to modify tigecycline’s la-
bel to include data about the in-
creased mortality risk.
Even when clinical evidence
points to significantly higher
risks between similar drugs,
manufacturers of the higher-
risk drugs can still profit. In this
case, tigecycline — the higher-
risk, lower-success-rate antibiot-
ic — generated sales for Pfizer of
$334 million in 2012, two years
after the FDA announced that
it was less safe than other
antibiotics.
“Had the FDA required a black
box warning for tigecycline soon-
er, fewer patients may have been
treated with this drug, and lives
might have been saved,” Carome
said. “The prominent warning
hopefully will prompt health care
professionals to consider safer
pharmaceutical options in the
future.”
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