June 15, 2018
Audience: Patient, Health Professional, Eye Care, Risk Manager
ISSUE: At least 43 patients reported adverse events after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields.
FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared in-house samples of Guardian’s product and found that autoclaving and sonication caused the poloxamer 407 to degrade. The amount of poloxamer 407 in Guardian’s product (12%, g/100 mL) is much greater than the maximum amount of poloxamers in FDA-approved ophthalmic products for topical administration (0.1-0.2%, g/100 mL), and the safety profile of drug products intended for intravitreal injection containing poloxamer 407 is unknown.
BACKGROUND: As part of its investigation into these adverse events, FDA collected and tested samples of Guardian’s product to identify and quantify the substances contained therein. FDA also prepared and tested in-house samples to assess the impact of autoclaving and sonication, which were used by Guardian during its compounding process, on the stability of the drug product. Below is a description of the test results and the agency’s analysis of those results.
RECOMMENDATION: Compounding pharmacies should determine, based on the route of administration and the organ or tissue involved, whether the excipients are safe in the amount that will be present in the administered dose. One way to accomplish this is to use an excipient in an amount where scientific data support its safety, such as data supporting FDA approval of a comparable drug product with a similar concentration of the excipient.
Compounding pharmacies also should consider whether the compounding process will generate degradants of such ingredients. Because compounded products are not evaluated by FDA for safety, effectiveness, or quality, health professionals should consult the compounding pharmacy about the safety information related to the excipients in the compounded products they plan to inject into their patients.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[06/14/2018 – Compounding Notification – FDA]