More than 12 million people in the U.S. suffer from a chronic health condition called interstitial cystitis (IC), which causes pain and pressure in the bladder area. The brand-name medication, Elmiron (pentosan polysulfate sodium), is the only FDA-approved drug for specifically treating IC. 

How Does Elmiron Work?

Elmiron works by providing a protective layer to the urothelium. The urothelium is a lining in the lower urinary tract. By protecting the urothelium, Elmiron may help prevent painful irritation caused by uric acid and other components of urine. 

The FDA-approved dosage of Elmiron is 100 mg, three times daily. However, in a 2015 study published in the Journal of Urology, in over 100 patients with IC, this dose was no more effective than placebo. 

Eye and Vision Damage Linked To Long-Term Elmiron Use

What’s more troubling is that many people who have taken Elmiron for a long time have developed irreversible eye damage. 

In 2018, two eye doctors from Atlanta’s Emory Eye Center published research in the journal, Ophthalmology. The study documented for the first time that some users of Elmiron, which was approved in 1996, were experiencing an eye disorder called pigmentary maculopathy. 

All six patients documented in the study were female with a diagnosis of IC (commonly known as painful bladder syndrome). Their median time taking Elmiron was approximately 15 years, and their symptoms were difficulty reading and adjusting to darkness. 

As a result of their findings, the doctors issued a warning about the bladder drug. 

Since then, there have been other documented cases of pigmentary maculopathy linked to Elmiron, which is manufactured by Jannsen Pharmaceuticals, a subsidiary of Johnson & Johnson. In addition, long-term use of the medication has been associated with other eye disorders, including macular degeneration and retinal maculopathy. 

Symptoms of Elmiron-Linked Eye Damage

Besides difficulty reading and adjusting to darkness, there are more serious vision problems that are linked to Elmiron, including the following symptoms:

• Eye pain
• Permanent vision loss
• Blurred vision
• Vision troubles at close up range
• Distorted/Disturbed vision

Researchers believe that Elmiron may be toxic to the tissues of the retina. If your retina becomes damaged, it may lead to permanent vision loss. In another study from 2018, 22 of 91 long-term users of Elmiron displayed retinal toxicity. 

Elmiron Lawsuits

The number of Elmiron lawsuits continues to grow. Plaintiffs allege that not only does long-term use of the drug cause toxic damage to the retina, there is also no warning about this potential side effect.  

Neither the drug’s guide, patient insert leaflet nor official website list permanent vision loss or any form of maculopathy as a warning or side effect. Janssen does list a few less-serious vision side effects such as conjunctivitis, but places these side effects in the less than 1% category. 

And despite the growing number of Elmiron cases, Janssen has yet to list maculopathy as a potential side effect in the drug’s product insert; maculopathy is the most common cause of blindness in North America. 

[Update: The “Warnings” section on Elmiron now indicates “Retinal Pigmentary Changes,” which the FDA approved of the label change on June 16, 2020.]

Plaintiffs allege that Jannsen knowingly has failed to disclose the potential link between the drug and serious eye damage. 

Prior to the documented cases of eye and vision damage, Elmiron was thought to be a relatively safe drug with low risk of side effects. However, research last year, presented at the American Academy of Ophthalmology, concluded there is a clear link between the drug and retinal damage. 

What Can Elmiron Users Who Have Suffered Eye or Vision Damage Do? 

If you took or have taken Elmiron every day for at least six months, are experiencing or have experienced vision problems, and you have been diagnosed with any disorder of the retina, you may qualify for a lawsuit against Elmiron. 

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References:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7012292/

https://pubmed.ncbi.nlm.nih.gov/29801663/

https://pubmed.ncbi.nlm.nih.gov/25245489/