Pd25-03 Elmiron: A Peek Into the Medicolegal World

You have accessJournal of UrologyInfections/Inflammation/Cystic Disease of the Genitourinary Tract: Interstitial Cystitis (PD25)1 May 2024PD25-03 ELMIRON: A PEEK INTO THE MEDICOLEGAL WORLD Aaron Tverye, Lynn McClelland, Fritz Kalaw, Shyamanga Borooah, Jennifer Anger, and Colby Souders Aaron TveryeAaron Tverye , Lynn McClellandLynn McClelland , Fritz KalawFritz Kalaw , Shyamanga BorooahShyamanga Borooah , Jennifer AngerJennifer Anger , and Colby SoudersColby Souders View All Author Informationhttps://doi.org/10.1097/01.JU.0001008584.88541.ff.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Elmiron (pentosan polysulfate sodium (PPS)) is the only FDA-approved medication to treat interstitial cystitis or bladder pain syndrome. In recent years, concerns regarding ocular adverse events associated with PPS use, specifically pigmentary maculopathy, have emerged. These concerns prompted the FDA to add a "Black Box warning" to PPS on June 16, 2020. The purpose of this study of the legal literature is to glean more clinical information about PPS ocular side effects and to understand potential legal vulnerability of the providers prescribing this medication. METHODS: A legal librarian performed a keyword search for legal documents containing the term "Elmiron" via the Westlaw database 2018-2023. All search results were reviewed by a legal librarian and a physician. Date and locations of claim filing, PPS use duration, adverse events, legal claims listed, and list of defendants were abstracted. RESULTS: A total of 41 legal documents were reviewed which included complaints and defense motions. 26 documents were legal claims filed between May 2020 - May 2021. All claims included plaintiffs with adverse ocular events after use of PPS. 16 of these included the duration of PPS use in their filing with an average of 13.4 years (range 2-25 years). Most common adverse event listed was toxic maculopathy (28%). See Figure 1 for ocular adverse events listed in the lawsuits. The defendants included the manufacturer and its subsidiaries. None of the legal claims named medical providers as defendants. The most common claims were Negligence, Product Liability, and Breach of Warranty amongst others. CONCLUSIONS: This convenient sample of product liability lawsuits related to PPS use provides insight into the rise in adverse event reporting surrounding the FDA "Black Box warning" in June 2020. Interestingly, no prescribing medical provider was listed as a defendant in any of the 26 legal claims. Ultimately, we plan to review the multidistrict class action lawsuit in New Jersey with over 1,800 claims pending as of October 2023. Ongoing analysis of these cases will provide further understanding of the association between PPS and pigmentary maculopathy and will guide informed consent discussions with patients. Download PPT Source of Funding: N/A © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e536 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Aaron Tverye More articles by this author Lynn McClelland More articles by this author Fritz Kalaw More articles by this author Shyamanga Borooah More articles by this author Jennifer Anger More articles by this author Colby Souders More articles by this author Expand All Advertisement PDF downloadLoading ...