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

  • Clinical Opinion
  • Published:
International Urogynecology Journal Aims and scope Submit manuscript

Abstract

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.

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Notes

  1. For completeness, we broadened our search to include all terms related to retinopathy.

  2. FAERS is a database that contains adverse event reports, medication error reports and product quality complaints resulting in adverse events that were submitted to FDA. The database is designed to support the FDA's post-marketing safety surveillance program for drug and therapeutic biologic products. FAERS receives over 1 millionannual reports of adverse events, and it contains over 22 million reports.

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Authors and Affiliations

  1. Division of Pharmacovigilance, Office of Surveillance and Epidemiology, FDA, Silver Spring, MD, USA

    Allison Lardieri, Karen Konkel, Lynda McCulley & S. Christopher Jones

  2. Division of Epidemiology, Office of Surveillance and Epidemiology, FDA, Silver Spring, MD, USA

    David Moeny & Adebola Ajao

  3. Division of Urology, Obstetrics, and Gynecology, Office of New Drugs, FDA, Silver Spring, MD, USA

    Christine Nguyen & Catherine Sewell

  4. Division of Ophthalmology, Office of New Drugs, FDA, Silver Spring, MD, USA

    Wiley Chambers

Authors
  1. Allison Lardieri
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  2. Karen Konkel
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  3. Lynda McCulley
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  4. S. Christopher Jones
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  5. David Moeny
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  6. Christine Nguyen
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  7. Catherine Sewell
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  8. Wiley Chambers
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  9. Adebola Ajao
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Contributions

A Lardieri, K Konkel, A Ajao: project development, data collection/management, data analysis, manuscript writing/editing.

L McCulley, SC Jones, D Moeny: project development, data analysis, manuscript writing/editing.

C Nguyen, C Sewell, W Chambers: project development, manuscript writing/editing.

Corresponding author

Correspondence to Allison Lardieri.

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The authors have no potential conflicts of interest and nothing to disclose. The views expressed are those of the authors and do not necessarily represent the position of the US FDA.

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Lardieri, A., Konkel, K., McCulley, L. et al. Pentosan associated retinal pigmentary changes: FDA’s perspective on an emerging postmarketing safety finding. Int Urogynecol J 32, 2891–2897 (2021). https://doi.org/10.1007/s00192-021-04970-0

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  • DOI: https://doi.org/10.1007/s00192-021-04970-0

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