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injections at the end of cataract surgery. The patients developed vari-
ous symptoms, including vision impairment, poor night vision, loss of
color perception, light sensitivity, glare, halos, flashing lights, ocular
discomfort, pain, loss of balance, headaches and nausea, according
to an FDA alert. In some cases, symptoms didn't appear until more
than a month after surgery.
When the outbreak was first discovered in April, cataract surgeon
Jeffrey Whitman, MD, whose patients at 2 Dallas surgical centers
were among those who suffered vision complications, told the Dallas
Mercury News, "It's devastating in many ways. I've been practicing for
31 years to help people see better, and I feel a little bit hopeless. I'm
more angry at the compounding pharmacy for making something that
injured our patients." Dr. Whitman declined to comment for this story.
At the time of the outbreak, Jack Munn, RPh, owner and president
of Guardian Pharmacy Services, which compounded the intravitreal
injections, told the Dallas Mercury News that Guardian was evaluat-
ing the triamcinolone-moxifloxacin compound. In a statement to
Outpatient Surgery, Guardian Pharmacy Services says it "is commit-
ted to the quality and safety of all of its compounded products and
has a rigorous quality assurance program in place. The health and
well-being of our patients is our foremost concern. While the pharma-
cy has been named as a defendant in one matter regarding compound-
ed triamcinolone-moxifloxacin, no connection has been established
between any Guardian product and the unfortunate adverse event
alleged in the lawsuit."
The incidents at the Dallas surgery centers likely won't be the last
time compounded drugs will be called into question. Of the estimated
4,500 U.S. outsourcing pharmacies, only 73 are currently registered
with the FDA, says Roy Sturgeon, PhD, a senior advisor at Lachman
Consultant Services, a pharmaceutical consulting firm based in
