L
ast month, the FDA issued an alert
about potential risks associated with
the intraocular use of compounded
moxifloxacin. The FDA had received
reports of toxic anterior segment syn-
drome (TASS) following injections of compounded
drugs containing bulk moxifloxacin or repackaged
and diluted FDA-approved moxifloxacin medica-
tions. A search of the FDA's Adverse Event
Reporting System database identified 29 cases of
TASS associated with drugs containing moxifloxacin.
Among the reports, 16 involved drugs compounded
with bulk moxifloxacin; 10 were associated with
repackaged Moxeza, a preservative-containing form
of moxifloxacin; the remaining incidents involved
unspecified (repackaged and/or diluted) forms of
Vigamox and Moxeza. Nineteen cases involved
cataract surgery; the others did not specify the type
of eye surgery in which the drugs were used.
The FDA released the alert to inform providers
that it's considering placing bulk moxifloxacin on
the list of medications that should not be com-
pounded for ophthalmic use. Many ophthalmic sur-
geons administer moxifloxacin during cataract sur-
gery to reduce the risk of post-op endophthalmitis,
which the FDA says is estimated to occur in .012%
to 1.3% of cases.
There is no FDA-approved moxifloxacin product,
but approximately half of ophthalmic surgeons
administer intracameral moxifloxacin at the time of
cataract surgery, according to Eric Donnenfeld, MD,
a cataract specialist at Ophthalmic Consultants of
Long Island in Garden City, N.Y. "Approximately
four million cataract cases are performed each year,
so about 2 million patients are administered intra-
cameral moxifloxacin annually," he says. "With that
perspective, twenty-nine cases of TASS is a very
low number."
S E P T E M B E R 2 0 2 0 • O U T P A T I E N T S U R G E R Y . N E T • 6 5
Dan Cook | Editor-in-Chief
FDA Issues Caution Over Moxifloxacin Eye Injections
Compounded forms of the drug have been
associated with toxic anterior segment syndrome.
PREVENTATIVE MEASURE Many surgeons inject moxifloxacin at the time of cataract surgery to reduce the risk of post-op endophthalmitis.
Pamela
Bevelhymer,
RN,
BSN,
CNOR
