FDA: Safety Alert for triamicinolone, moxifloxacin intravitreal injection by Guardian Pharmacy Services

Editor's Note

The Food and Drug Administration on July 28 issued a Safety Alert for compounded triamicinolone and moxifloxacin for intravitreal injection by Guardian Pharmacy Services (Dallas, Texas). [The Guardian Pharmacy Services in Dallas is not affiliated with the national long-term care Guardian Pharmacy Services, LLC headquartered in Atlanta.]

The FDA has received adverse event reports on at least 43 patient who were administered this product at the end of cataract surgery procedures at the PRG Dallas Ambulatory Surgery Center.

Over the course of several months, patients developed symptoms such as, vision impairment, poor night vision, loss of color perception, photophobia, glare, halos, flashing lights, ocular discomfort, pain, loss of balance, headaches, and nausea. Many of the symptoms were not exhibited until at least 1 month postoperatively.

Posted 07/28/2017] AUDIENCE: Ophthalmology, Pharmacy, Patient ISSUE: FDA received adverse event reports on April 5 and June 1, 2017, concerning at least 43 patients who were administered intravitreal (eye) injections of a drug containing triamcinolone (steroid) and moxifloxacin (anti-infective) compounded by Guardian Pharmacy Services in Dallas, Texas.