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The interstitial cystitis drug Elmiron can cause permanent vision damage, according to a class action lawsuit filed earlier this month in the Supreme Court of British Columbia.
Plaintiff Arenlea Felker filed the Elmiron side effects class action lawsuit against Janssen Inc. and Teva Branded Pharmaceutical Products R&D Inc.
Janssen and Teva design, develop, market, label and sell Elmiron (pentosan polysulfate sodium) for the treatment of interstitial cystitis, which is a pain syndrome that affects the bladder and pelvic region. Elmiron has been sold in Canada since 1993.
Pentosan polysulfate sodium was first used in the 1950s for its anticoagulant properties to treat varicose veins. In the 1980s, a series of clinical trials found that Elmiron was effective in the treatment of interstitial cystitis.
Arenlea claims that exposure to Elmiron causes a “permanent vision-threatening eye disease” called pigmentary maculopathy.
According to the Elmiron side effects class action lawsuit, drug toxicity can occur as the result of taking drug compounds that are foreign to the human body. Depending on the type of drug and dosage, drug toxicity can affect the entire bodily system or just a specific organ.
The retina, a membrane of nerve cells at the back of the eye, is particularly vulnerable to drug toxicity due to its highly-concentrated network of blood vessels and minimal ability to regenerate, according to the Elmiron side effects class action lawsuit.
Elmiron can cause pigmentary maculopathy when used as intended, Arenlea alleges. As Elmiron circulates through the bloodstream, it accumulates in the retinal pigment epithelium, which is essential to retinal health. The retinal pigment epithelium has many functions including transporting nutrients, absorbing light and protecting against photooxidation. According to the Elmiron class action lawsuit, accumulation of Elmiron in this part of the retina can lead to vision problems such as pigmentary maculopathy.
“The Defendants exposed the Plaintiff and Class Members to retinal toxicity and pigmentary maculopathy by their negligence and failure to warn about the effects of ingesting Elmiron,” the Elmiron side effects class action lawsuit claims. “Through this suit, Canadians who took Elmiron seek to hold the Defendants accountable and recover damages.”
Arenlea says she was initially prescribed Elmiron to treat interstitial cystitis in 2005 and has continued to take the medication daily. Arenlea, like most other patients who take Elmiron, ingest the medication daily for many years.
After taking Elmiron, Arenlea has allegedly suffered symptoms of pigmentary maculopathy including blurred vision, difficulty reading, poor light to dark adaptation, less vivid colors and possibly other injuries that may develop over time.
According to the Elmiron side effects class action lawsuit, a clinical trial was conducted prior to Elmiron’s approval by Health Canada, in which patients reported vision-related adverse side effects.
However, the defendants allegedly failed to adequately investigate these vision-related adverse side effects and failed to warn patients, health care professionals and Health Canada about the potential Elmira side effects. Therefore, eye health care professionals may not have known to look for certain signs of pigmentary maculopathy or other vision changes when a patient is taking Elmiron. As a result, symptoms of pigmentary maculopathy may be mistaken for other macular disorders and will remain undiagnosed and/or untreated.
The Elmiron side effects class action lawsuit also notes that, because retinal toxicity and pigmentary maculopathy associated with Elmiron has been widely reported in the ophthalmological community since at least 2018, the defendants knew that the drug posed a risk.
Arenlea says that she would not have taken Elmiron if she had known about the risk of retinal toxicity, pigmentary maculopathy and other adverse vision side effects associated with the drug. Instead, she says she would have pursued one or more of the available treatments for the condition.
According to the Elmiron class action lawsuit, Elmiron is only one of many treatments that can treat interstitial cystitis. The Canadian Urological Association recommends a wide range of potential therapies depending on the severity of a patient’s symptoms. Recommended treatments include patient education, dietary modification, bladder training, acupuncture and other physical therapies, oral medications, intravesical therapies, minimally-invasive surgery, and radical surgical procedures.
By filing the Elmiron side effects class action lawsuit, Arenlea seeks to represent herself and a proposed Class of all persons in Canada who were prescribed and ingested Elmiron since Dec. 31, 1993.
The Elmiron class action lawsuit seeks general damages, restitution or disgorgement for the cost of Elmiron purchases made in Canada, punitive damages, special damages, past and future damages, recovery of health care costs, pre- and post-judgment interest, and other relief the court deems just.
Have you ever used the interstitial cystitis drug Elmiron? Tell us your story in the comment section below!
Arenlea is represented by Anthony A. Vecchio QC, James A. Richards, Saro J. Turner, Nicole M. Kelly, Sam J. Jaworski, and Mathew P. Good of Slater Vecchio LLP.
The Elmiron Side Effects Class Action Lawsuit is Arenlea Felker v. Janssen Inc., et al., Case No. VLC-S-S-205093, in the Supreme Court of British Columbia, Canada.
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16 thoughts onElmiron Class Action Lawsuit Alleges Serious Side Effects
My sister was diagnosed with IC when she was quite young; the 70s. She just had an MRI and is having surgery for cancer on her right kidney. She has poor night vision and I am not sure about any degeneration. Will get her an apt with eye specialist. She is only 59 years old. Her hair loss was quite high for the first few months and then her tongue was black for 5 days. I will help her fill out the forms when she gets out of surgery and is up and around feeling better.
I feel better knowing she is not alone, but so sad at how many are suffering. Such a shame.
My mother has been taking Elmiron for years (17 years or so) and had a macular hole in one eye. She had surgery and had that corrected. When COVID first hit she started developing the same symptoms in her other eye. Due to her health and covid being so risky her doctor advised not being concerned with it until her other issues were taken care of. She is currently in surgery as we speak but her now she is completely blind in her left eye.
I was taking elmiron for 22 years! My vision used to be amazing and it’s been been deteriorating for sometime now. I just happened to look up the ingredients to elmiron earlier this year and saw it contained aluminum… So I discontinued it. Recently the IC pain increased so I was considering going back on… but I googled it and started reading about all these class action lawsuitS. It totally explains my vision problems and I’m going to see my eye doctor next week! This is terrible!
I took Elmiron for years. I had severe pain from interstitial cystitis and was told by my doctor that this was the only medication available to treat it. I’ve worn glasses since childhood, so I never connected and eye issues to this drug, but I’ve become very sensitive to bright light and my vision has become progressively worse long after my eye doctor said it should have settled. I eventually did some research on my own and ended up switching to aloe vera pills (for those of you looking for an alternative, it’s worked for me so far), but it’s disheartening to see that some of my vision issues may have been preventable.
I had been taking Elmiron for approximately 1 years. My eye sight started deteriorating where i was needing new prescription every 2 years. I stopped taking Elmiron 4 weeks ago when I read that it could cause vision problems. This is so scary thinking that this has possibly been the reason my eye sight has deteriorated. It is costly getting new glasses all the time and being newly retired with limited coverage makes it more so.