Patients who used Elmiron started developing abnormal damage to the retina

What is Elmiron?

Elmiron, or pentosan polysulfate sodium, is a medication used to treat bladder pain and discomfort related to interstitial cystitis. It is manufactured by Janssen Pharmaceuticals, a corporate subsidiary of Johnson & Johnson. Elmiron was approved by the FDA in 1996; since then, it has been the standard treatment for people who suffer from interstitial cystitis, and it still is the only drug FDA-approved to treat people with this condition.¹ 

Linked to eye damage

In 2018, doctors from the Emory Eye Center (Atlanta) noticed that some patients who used Elmiron started developing abnormal damage to the retina. In a study by these doctors of six patients who had been treated with Elmiron, four of the six experienced difficulty reading, nearly all eyes showed subtle paracentral hyperpigmentation at the level of the retinal pigment epithelium (RPE), and two patients showed paracentral RPE atrophy.²

In 2019, researchers in a study published by the American Academy of Ophthalmology investigated patients from Kaiser Permanente in northern California, and “about a quarter of patients with significant exposure to Elmiron showed definite signs of eye damage, and that this medication toxicity could masquerade as other known retinal conditions, such as age-related macular degeneration or pattern dystrophy.” ³

The Lawsuit 

Apparently, the manufacturers were aware of this, and they failed to warn that taking Elmiron could lead to eye damage. Instead, in 2020, the FDA released information about these side effects and informed the public about the changes to the warning on the label. ⁴

Patients who had been prescribed Elmiron and developed maculopathy and vision problems started accusing Janssen Pharmaceuticals of failing to warn the public about the risks of ocular toxicity and potentially permanent vision damage or loss.⁵

Legal status

The cases were consolidated in the MDL 2973 IN RE: ELMIRON (PENTOSAN POLYSULFATE SODIUM) PRODUCTS : MDL No. 2973 LIABILITY LITIGATION. 

As of June 8, 2022, attorneys have filed and served 1,041 product liability claims relating to the use of Elmiron (915 federal and 126 in state courts). The total number of cases pending as of September 2022 in the Elmiron MDL was 1,774, and the first bellwether test trial is set to go forward in January. This will be followed by a second trial in March and a third test trial in May.⁶

Sources: 1. Elmiron. (N.D). Retrieved from: https://www.orthoelmiron.com/ 2. National Library of Medicine (May 22, 2018). Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium. Retrieved from: https://pubmed.ncbi.nlm.nih.gov/29801663/  3. American Academy of Ophthalmology (OCT 12, 2019). More Evidence Linking Common Bladder Medication to a Vision-threatening Eye Condition. Retrieved from: https://www.aao.org/newsroom/news-releases/detail/evidence-linking-bladder-medication-eye-condition 4. Miller & Zois (N.D). Elmiron Lawsuit Attorneys. Retrieved from: https://www.millerandzois.com/elmiron-lawsuit-attorneys.html#:~:text=In%20all%20three%20Elmiron%20lawsuits,be%20held%20in%20January%202023 .  5. FDA.  (DEC 3, 2021). Drug Safety-related Labeling Changes (SrLC). Retrieved from: https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?utm_campaign=SLC%2006%2F19%2F2020&utm_medium=email&utm_source=Eloqua&event=searchdetail.page&DrugNameID=2277&elqTrackId=6341bffef55c43aea584746cb90e63a2&elq=08eb40c1c44f4255ae507b6937c6d921&elqaid=13024&elqat=1&elqCampaignId=11094  6. United States District Court . District of New Jersey. (N.D). Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation. Retrieved from: https://www.njd.uscourts.gov/elmiron-pentosan-polysulfate-sodium-products-liability-litigation