The FDA issued an alert over Dallas-based Guardian Pharmacy Service's compounded triamcinolone and moxifloxacin product for intravitreal injection after the FDA received 43 adverse event reports.
Here's what you should know:
1. The reports came from 43 cataract surgery patients who had procedures performed at Dallas-based PRG Dallas Ambulatory Surgery Center.
2. The product was injected into the eye to provide postoperative prophylaxis for ocular inflammation and endophthalmitis as an eye drop alternative.
Over the course of several months patients developed:
- Vision impairments
- Poor night vision
- Loss of color perception
- Photophobia
- Glare
- Halos
- Flashing Lights
- Ocular discomfort
- Pain
- Loss of balance
- Headaches
- Nausea
Some of the symptoms took at least a month to develop.
3. The injections were administered by physicians associated with the Key Whitman Eye Center, the Park Central Surgical Center and Tylock-George Eye Care, all in Dallas.
4. Some of the symptoms improved at the five-month follow-up, but for many patients the symptoms remain.
5. The FDA has not reviewed compounded drugs for safety, effectiveness or quality. The FDA encourages physicians to report adverse events associated with compound drugs.
Note: Guardian Pharmacy Services in Dallas is not affiliated with the national long-term care company, Guardian Pharmacy Services in Atlanta.