Elmiron Class Action Lawsuit Alleges Serious Side Effects

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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