The US Food and Drug Administration (FDA) issued a safety alert today after serious adverse events were reported in at least 43 patients who received intravitreal injections of a drug that contained compounded triamcinolone and moxifloxacin product.
Guardian Pharmacy Services in Dallas, Texas, compounded the product, which was administered to patients at the end of cataract surgery at the PRG Dallas Ambulatory Surgery Center in Dallas by physicians affiliated with the Key Whitman Eye Center, and at the Park Central Surgical Center in Dallas by physicians affiliated with Tylock-George Eye Care.
The FDA received reports of the adverse events on April 5 and June 1, 2017.
The steroid-anti-infective combination was administered into the vitreous of the eye after cataract surgery to prevent postoperative ocular inflammation and endophthalmitis; the expectation was that the patients would not need to use postoperative eye drops.
During several months postoperatively, patients developed a variety of symptoms including vision impairment, poor night vision, loss of color perception, photophobia, glare, halos, flashing lights, ocular discomfort, pain, loss of balance, headaches, and/or nausea. Some symptoms did not occur until a month or longer after surgery.
Among the Park Central patients, physicians found the patients experienced decreased visual function that involved both visual acuity and visual fields. Initial optical coherence tomography testing revealed macular edema, which was followed by retinal degeneration in some patients.
Some patients experienced symptom improvement during the 5 months postoperatively; however, a number of patients continue to experience "a significant reduction in best-corrected visual acuity and visual fields," the FDA writes in the safety alert.
The FDA notes that it does not review compounded drugs for safety, effectiveness, or quality.
The FDA recommends that healthcare professionals and patients using these products report adverse events or side effects to the FDA's MedWatch Safety Information and Adverse Event Reporting Program by completing and submitting the report report online. The form can also be downloaded or requested by calling 1-800-332-1088. Completed forms can be returned to the address on the pre-addressed form, or submitted by fax to 1-800-FDA-0178.
Cite this: FDA Warns About Triamcinolone and Moxifloxacin Combo for Eye - Medscape - Jul 28, 2017.