Postmarketing surveillance rates of uveitis and scleritis with bisphosphonates among a national veteran cohort

Retina. 2008 Jun;28(6):889-93. doi: 10.1097/IAE.0b013e31816576ef.

Abstract

Purpose: Uveitis and scleritis are the most serious ocular side effects of bisphosphonate therapy. The purpose of this study was to determine the 6-month rates of uveitis/scleritis following dispensing of bisphosphonates in a large veteran cohort.

Methods: Two national databases (clinical and pharmacy) for fiscal year (FY) 2006 were linked to identify new diagnoses of uveitis/scleritis following the initial dispensing of bisphosphonate drugs. New diagnoses in FY 2006 were identified using International Classification of Diseases, Version 9, Clinical Modification (ICD-9-CM), in a cohort of veterans without a previous diagnosis of uveitis or scleritis using a look-back period to FY 2005. The new diagnoses were temporally aligned with initial dispensing of bisphosphonates and the rates of new cases were calculated for 1-month and 6-month time intervals.

Results: There were 7.9 new cases of uveitis/scleritis per 10,000 individuals with a newly dispensed bisphosphonate that occurred within 180 days. The relative risk of uveitis/scleritis for 6 months was 1.23 (95% confidence interval: 0.85-1.79) compared to veterans not exposed to the medications. The rates of uveitis/scleritis did not differ significantly based on route of administration (oral or parenteral) or after age adjustment. Just over a third of the diagnoses were scleritis. Nearly 43% of patients with uveitis/scleritis after bisphosphonate use had a systemic diagnosis commonly associated with inflammation of the uveal tract or sclera.

Conclusions: The 30-day and 6-month rates of uveitis/scleritis following the dispensing of a bisphosphonate drug are low and do not differ significantly from rates recorded for veterans not dispensed these drugs.

MeSH terms

  • Administration, Oral
  • Aged
  • Aged, 80 and over
  • Alendronate / adverse effects*
  • Bone Density Conservation Agents / adverse effects*
  • Databases, Factual
  • Diphosphonates / adverse effects*
  • Drug Prescriptions / statistics & numerical data
  • Female
  • Humans
  • Infusions, Parenteral
  • Male
  • Middle Aged
  • Pamidronate
  • Pharmacy Service, Hospital / statistics & numerical data
  • Product Surveillance, Postmarketing / statistics & numerical data*
  • Scleritis / chemically induced*
  • Scleritis / diagnosis
  • Scleritis / epidemiology
  • United States
  • United States Department of Veterans Affairs / statistics & numerical data*
  • Uveitis / chemically induced*
  • Uveitis / diagnosis
  • Uveitis / epidemiology
  • Veterans / statistics & numerical data

Substances

  • Bone Density Conservation Agents
  • Diphosphonates
  • Pamidronate
  • Alendronate