FDA Warns of Adverse Events for Intravitreal Injection Drug

Last week, the FDA announced multiple adverse event reports associated with intravitreal injections of a combination drug including triamcinolone and moxifloxacin. The drug in question was compounded by Guardian Pharmacy Services in Dallas, TX, according to a press release.

The FDA received at least 43 reports between April 5, 2017, and June 1, 2017, regarding the compounded product. All patients were administered the drug at the end of cataract surgery conducted at the PRG Dallas Ambulatory Surgery Center and the Park Central Surgical Center.

The agency reported that the drug was injected into the vitreous of the eye at the end of the surgery as a prophylactic treatment. The intention of the injection was to prevent ocular inflammation and endophthalmitis, with the expectation that the patient did not use eye drops after the surgery, according to the release.

Patients reported 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, according to the FDA. The reports indicated that many symptoms did not occur until at least 1 month after the surgery.

Upon follow-ups of patients treated at Park Central, physicians noted diminished function regarding visual acuity and visual fields among patients treated with the drug, according to the FDA.

Optical coherence tomography testing showed macular edema, which was the precursor to retinal degeneration in some patients, according to the release.

Although some symptoms improved in certain patients over 5-month post-operation, many patients experienced a significant reduction in visual acuity and visual fields, according to the FDA.

While compounded drugs can be important for some patients, the FDA warns that they have not been reviewed by the agency and may put individuals at risk.

The FDA encourages healthcare providers and patients to report adverse events and product quality problems observed with compounded drugs to MedWatch Adverse Event Reporting program, the press release concluded.

The Guardian Pharmacy Services in Dallas is not affiliated with the national long-term care Guardian Pharmacy Services headquartered in Atlanta, GA.