Elmiron (pentosan polysulfate sodium) is a prescription medication that was approved in 1996 for the treatment of interstitial cystitis. This condition is sometimes referred to as painful bladder syndrome and can consist of a range of symptoms. These can vary from the occasional mild discomfort to constant and significant pain in the bladder or lower abdomen of the body.
Currently, Elmiron is the only FDA-approved oral medication to treat interstitial cystitis. As a result, numerous individuals have taken the medication for an extended period. But over the past few years, several studies have been published that indicate that some people may suffer from vision problems from taking Elmiron. Some of the more notable studies came out in 2018 and 2019.
This blog post will examine the possibility of Elmiron causing vision loss in patients, its current status with the U.S. Food and Drug Administration (FDA), and what its makers, Janssen Pharmaceuticals, Inc. (Janssen) and Johnson & Johnson, potentially face in litigation.
Does Elmiron Cause Vision Loss?
It’s very possible. What’s interesting about this drug is that scientists aren’t even 100% sure how it works. According to the FDA, it’s believed that Elmiron attaches itself to the inside of the bladder to reduce any irritating effect urine may have on the bladder wall.
The FDA now reports that long-term use of Elmiron may cause pigmentary maculopathy. This is the technical term for pigment changes in the retina of the eye.
The retina is the back of the eye that contains many of the cells (such as rods and cones, if you recall from your elementary or middle school days) and nerves that make vision possible. Unfortunately, the FDA doesn’t know exactly how or why Elmiron harms the retina.
- Trouble adjusting vision to low-light environments
- Blurred vision
- Difficulty reading, especially in reduced light
Most instances of pigmentary maculopathy have occurred in patients who have taken Elmiron for more than three years. However, there are reports of vision problems in those who have used Elmiron for shorter periods.
One of the most troubling aspects of these vision problems is that they are very similar to age-related macular degeneration and pattern dystrophy. So it’s very possible that many patients were misdiagnosed with one of these eye conditions. And as a result, they continued taking Elmiron, further worsening the damage to their retinas.
Has the FDA Done Anything About Elmiron?
Yes, but not much. On June 16, 2020, the FDA approved Janssen’s request for a labeling change. Specifically, the “Warnings” section will now mention pigment changes to the retina. Before this change, there was nothing listed under the Warnings section. This follows what other governmental regulatory agencies are doing.
For example, as early as June 2019, the European Medicines Agency recommended Elmiron labeling changes to reflect the newly recognized risk of pigmentary maculopathy.
Are There Any Elmiron Lawsuits?
Yes, there are a few. Given how recent these Elmiron developments are, there aren’t a large number of lawsuits and many have been filed just this year. This means they’re in the very early stages of litigation.
In Allen v. Janssen, the plaintiff filed a proposed class-action lawsuit in May 2020 where she seeks a declaration that Elmiron is a defective drug, medical monitoring and damages. The plaintiff argues that the defendants did not properly test Elmiron, did not report the risk of vision problems to the FDA and failed to warn users of Elmiron of its risks.
Another case, Pisco v. Janssen, involves a plaintiff arguing strict liability and negligence causes of action against the defendants. Plaintiff seeks a variety of damages, including pain and suffering, medical costs and lost wages.
There have been tens of thousands of patients who took Elmiron. So many more cases are likely. However, it’s very early in the litigation process, so not much is happening right now. But if there’s a notable development, I will keep you updated. If you have any questions, you can call me at 919.546.8788.