Abstract
Purpose :
Scleritis is a serious adverse event that has been reported with zoledronic acid and other biphosphonates. A patient presented two months after infusion with zoledronic acid with severe scleritis. A recent literature review reported 35 cases that developed orbital/ocular inflammation 6 hours to 7 days after zoledronic infusion. The purpose of this study is to analyze the scleritis cases associated with zoledronic acid in the US Food and Drug Administration's adverse event reporting system (FAERS). FAERS is designed to support the FDA's post-marketing safety surveillance program for drug and therapeutic biologic products.
Methods :
The search term “zoledronic acid” and the Medical Dictionary for Regulatory Activitie (MedRa) term "scleritis" was used to search the FAERS database.
Results :
58 unique case identification numbers were present in the FAERS database that had both "scleritis" and "zoledronic acid". Only 8 of 58 cases occured in males. The mean age of reported cases was 65 years of age. The event dates were reported for 32 cases from 2004 through 2019. 9 Aclasta™, 12 Reclast™, 1 zoledronic acid, 15 Zometa™ were listed as the suspect biphosphonate product names (21 were without entered text). In 27 cases, only osteoporosis was reported as the reason for use of zoledronic acid and 16 separate cases used zoledronic acid as part of an oncologic treatment regimen. Only three cases had scleritis alone reported as the sole reaction. The majority of cases reported multiple other ocular findings.
Conclusions :
FAERS has no isolated field within its publically available data to analyze reported interval between administration of medicine and onset of adverse event. Further analysis of administration of zoledronic acid and time interval to onset of scleritis should be performed.
This is a 2020 ARVO Annual Meeting abstract.