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FDA receives reports of serious adverse events after triamcinolone, moxifloxacin compound injections
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The FDA is warning clinicians about serious adverse events reported after intravitreal injections of triamcinolone and moxifloxacin compounded by Guardian Pharmacy Services in Dallas.
At least 43 patients at two Dallas surgery centers experienced serious adverse effects after receiving the injection following cataract surgery. The FDA received the adverse event reports on April 5 and June 1.
Symptoms over several months included vision impairment, poor night vision, loss of color perception, photophobia, glare, halos, flashing lights, ocular discomfort, pain, loss of balance, headaches and nausea, the FDA said in a release. Some symptoms did not present until 1 month after surgery.
Follow-up examinations showed patients had diminished visual function involving visual acuity and visual fields. Macular edema was seen on OCT, followed in some cases by retinal degeneration.
“While the symptoms reportedly improved in some patients over the 5-month postoperative period, a number of patients remain with a significant reduction in best corrected visual acuity and visual fields,” the release said.
Clinicians and patients are asked to report any adverse events related to these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report.
Perspective
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John Berdahl, MD
Physicians are and have always been the primary interface for patients in the medical system. The responsibilities of physicians are evident in the oath that we took to put the patient’s needs in front of our own and to do no harm. The increasing challenge of this oath is how the individual patient interacts with our responsibility to society in general — to societal medicine as a whole.
This challenge comes into acute relief in the setting of compounded medications. Recently, a retinal toxicity outbreak that appears to be due to a local compounding pharmacy may have led to dozens of patients losing significant vision. I understand why doctors want to use compounded intraocular medications. First, the data, particularly out of Europe and some from the United States, indicated that intraocular antibiotics are the most effective way to decrease the devastating complication of endophthalmitis. Secondly, there is no FDA-approved medication for endophthalmitis prophylaxis, either topical or intraocular. Lastly, the cost of both generic and branded eye drops has gone up extensively.
When combining all of these factors, it is rational to use a low-cost compounded intraocular antibiotic and/or inflammatory medication to help prevent endophthalmitis and decrease costs to the patient and the system. In fact, if it were my eye, it is what I would want.
However, local compounding pharmacies need to ensure that the products we are getting are safe for intraocular use. Without safety first, one isolated event can have enormous consequences not only for the individual patients who experience vision loss, but also for our profession and society as we try to deliver better care in a more cost-effective way.
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