Pentosan associated retinal pigmentary changes: FDA's perspective on an emerging postmarketing safety finding

Introduction and hypothesis Recent publications describe pigmentary changes in the retina associated with the use of pentosan polysulfate sodium, the only FDA-approved oral agent for relief of bladder pain or discomfort associated with interstitial cystitis. Methods To evaluate this association, we reviewed data from the FDA Adverse Event Reporting System and published case reports and observational studies. Results The totality of clinical and epidemiology evidence does not resolve the question of causation between pentosan use and retinal pigmentary changes; however, several elements support a potential association. Conclusion Here, we provide our perspective on the available evidence the agency weighed when retinal pigmentary changes were added to pentosan labeling. It is important for urogynecologists prescribing pentosan to be aware of this potential association and be vigilant about assessing eye health in pentosan users.

Automated summary

The data reviewed from the FDA Adverse Event Reporting System and published case reports and observational studies do not definitively establish a causal link between the use of pentosan polysulfate sodium and retinal pigmentary changes. However, there are several elements that suggest a potential association. Urogynecologists prescribing pentosan should be aware of this possible association and monitor the eye health of pentosan users attentively.