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www.fdanews.com/articles/182891-fda-issues-adverse-event-alert-for-guardian-pharmacys-eye-drugs

FDA Issues Adverse Event Alert for Guardian Pharmacy’s Eye Drugs

August 3, 2017

The FDA received two adverse event alerts affecting at least 43 patients given injections of drugs compounded by Guardian Pharmacy.

The patients were administered the product, a drug containing triamcinolone and moxifloxacin, following a cataract surgery procedure at PRG Dallas Ambulatory Surgery Center. The product was injected into the vitreous of the eye to prevent inflammation. Affected patients later developed symptoms ranging from impaired vision and light sensitivity to headaches and nausea.

Some patients’ symptoms improved over the five months following the operation, but many still have significantly decreased vision, the agency said. The alert notes that the FDA does not review compounded drugs for safety, quality and effectiveness.

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