Elmiron was put on the market in the mid-1990s to deal with serious internal cyst conditions. However, while the intent was to deal with cystitis, the medication has been positively linked to an unwanted problem, vision loss. It’s an odd playout for a bladder condition medication, but pharmaceuticals that are not researched enough before going into production have historically ended up proving themselves with serious negative side effects over time.
The above is not to say that Elmiron was not researched at all. The Food and Drug Administration put Elmiron through the standard reviews and tests, eventually approving the drug as a blood thinner in 1996. However, no one picked up on the additional side effect of eye damage at the time. It wasn’t until some 24 years later, that the FDA came back with a public warning about Elmiron’s link to eye damage, specifically in the form of pigmentary maculopathy.
No surprise, those who were already suffering from the side effects confirmed the same, with symptoms including fuzzy vision, blurring, light adjustment, and similar issues. However, many assumed the eye-damaging side effects stopped after the drug was canceled. As it turns out, now doctors and the FDA have been warning former patients to also receive annual eye exams, specifically looking for symptoms of pigmentary maculopathy development well after the drug has been stopped. Annual retina checks may confirm what is starting to develop downstream, but it does nothing for patients who had no warning in the first place of a long-term side effect.
Elmiron was supposed to help protect the bladder from irritants that were causing it to become inflamed. Most patients took a dosage of at least 300 mg, and many took the drug for years after it became available as an ongoing treatment versus an actual cure for interstitial cystitis. The alternative in cases that could become worse was surgery and removal of part of the bladder. Most opted for the drug pathway instead. However, by 2018, it was becoming clear that patients who had been under ongoing treatment for at least a decade and longer were showing clear signs linked to Elmiron use. The inability to see with low light and loss of focus was well beyond the typical age-related vision degeneration most people normally experience after their mid-forties. This was most evident in patients where families had no retinal disease conditions, a red flag that something else than genetics was causing the visual symptoms. A year later, Elmiron was confirmed as the primary factor.
While many could argue that older patients are being confused with well-known age-related vision conditions, pigmentary maculopathy is very rare in comparison. Yet a high number of patients with it were also or had taken constant dosing of Elmiron. The pharmaceutical manufacturer of the drug, Janssen Pharmaceuticals, did not place a clear warning on Elmiron of potential vision problems until 2020.
In short, for those who have taken the drug in the past and stopped, their eyesight might still be at risk if you no longer take Elmiron. A number of lawsuits have been filed on the matter, and those who are still being injured by the drug well after stopping are eligible to be represented. The cases are now being combined in federal court as a single jumbo litigation for coordinated activities. People potentially harmed also do not need to wait until they actually manifest vision problems. Representation can begin now based on the fact of being prescribed Elmiron in the first place without the requisite warnings about vision damage.
