Elmiron Class Action Lawsuit Launched In Canada

DrugsLegal News

Two Canadian women, each with a long history of using Elmiron, a drug for interstitial cystitis (IC)—otherwise known as painful bladder syndrome—have joined a class-action lawsuit against the drug’s maker, the Johnson & Johnson subsidiary, Janssen Pharmaceuticals, alleging the company did not disclose the risks of eye damage as a side effect of the drug, sufficiently to the public.

Should the plaintiffs emerge successful, they may be awarded up to $500,000 each. Canadian Television News (CTVNews.ca) reports that one of the women is an archaeologist, who claims she now has trouble seeing in dim lighting, and that color and brightness are diminished for her. Archaeologists must depend on properly-functioning vision in order to observe very small details. 

The archaeologist was first prescribed Elmiron in 2004 for IC, which is a chronic disease that causes pressure and severe pain in the bladder, and mostly affects women. Elmiron (pentosan polysulfate sodium) is the only oral drug available for this condition. 

“It started out with distortion of lines, and that progressively got worse,” the archaeologist told CTV News, adding that her failing vision has her worried about driving and her “ability to walk up and down stairs.”

In addition to relying on her vision to make minute observations, another part of the archaeologist’s job involves hiking in rugged, mountainous regions, which requires steady, dependable footing. But with her diminished vision caused by Elmiron, the archaeologist suggests she does not feel comfortable with this element of her job. 

Although she started taking Elmiron in 2004, she wasn’t aware of the connection between the drug and permanent eye damage until August of last year, when her eye doctor mentioned the association. From that point on, the archaeologist started researching Elmiron side effects. Based on her findings, she decided to stop taking the drug. In one study, one-quarter of those who used Elmiron for 5 years or longer had experienced significant damage to the retina. Moreover, researchers found an association between Elmiron users who were significantly more exposed to the drug and more severe atrophy.

As for how it’s known that it’s the drug that causes the vision loss and not genetics, a study from 2018 addressed this topic, and concluded that retinal damage from Elmiron is indeed distinguishable from genetic or hereditary damage. 

Moreover, a retrospective study found that even after patients stop taking the drug, vision loss may progress. 

Researchers from Emory University in Atlanta, Georgia were first to sound the alarm about Elmiron, and publish data about its side effects in peer-reviewed research journals. One of those researchers was Dr. Nieraj Jain, who told CTVNews.ca, that Elmiron may damage light-sensing cells called photoreceptors. Additionally, the lining of cells under photoreceptors, the retinal pigment epithelium, may also become damaged because of long-term Elmiron usage.

“Those cells need to be working well … in order for us to have a very sharp vision that we have. And in patients who have this Elmiron-related maculopathy, we’re seeing disturbances in the pigmentation there, and degeneration or loss of some of those cells,” Dr. Jain told CTVNews.ca.

Dr. Jain added that retina problems could persist for up to 20 years or even worsen down the road. 

The other lead plaintiff in the Canadian class-action lawsuit is a London, Ontario-based shop owner, who claims she started taking Elmiron in 2002, and stopped taking it 13 years later, due to its expense. The shopkeeper says the first vision problem she experienced was “floaters” (floating clear spots). Over time, reading became more difficult, as did driving at night, and recognizing customers in her shop—even when they were standing right in front of her. 

“I’m not going to have the freedom to drive, I am not going to have the ability to enjoy my books. It’s going to affect my whole lifestyle,” she told CTVNews.ca.

Without doubt, IC sufferers are stuck between a rock and a hard place. On one hand Elmiron is considered efficacious at easing painful bladder syndrome, albeit at the cost of perhaps sacrificing vision. The Canadian Urological Association’s eponymous journal published a study in February 2020 that warned about possible long-term vision damage associated with Elmiron. 

In the US, approximately 80 Elmiron lawsuits have been filed, with 42 claims assigned to multidistrict litigation in a New Jersey federal court. In July 2020, Janssen Pharmaceuticals finally added a warning about pigmentary damage to its product insert and monograph.

Users of Elmiron are encouraged to get regular eye exams and report any vision problems to their eye doctor.

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