A recent scientific study published by the Northwestern University Department of Ophthalmology in February of this year may provide greater insight into identifying causal links between Elmiron use and subsequent vision loss. Examining data of 131 patients over a period of 17 years known to have taken Elmiron for symptoms of interstitial cystitis, the study found that a relationship between Elmiron and macular pathology—which may lead to vision loss— exists and was able to confirm recent findings by other authors regarding the relationship between Elmiron and vision loss.
Based on this data, the researchers concluded that use of Elmiron can induce vision loss via maculopathy, making certain objects appear blurry. More importantly, this relationship may be identified by regular ophthalmologic imaging. This study is significant in that it aids plaintiffs in helping prove that their injury was caused by Elmiron.
Although Elmiron was approved by the FDA in 1996, the FDA only recently released an announcement in June of 2020 stating:
“Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON® (see ADVERSE REACTIONS). Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor.”
The FDA’s delay in identifying these potential injuries seems to have been due to the fact that chronic exposure to Elmiron is an important factor in the extent of vision loss—as the data from the Northwestern University study indicates. Unfortunately, cessation of Elmiron use may not prevent maculopathy from progressing. However, what is sure to be uncovered in pending lawsuits against the makers of Elmiron is whether they knew about this relationship between vision loss and their product.