TORONTO – You have been prescribed a drug called Elmiron to help with persistent bladder pain. But now two Canadian women seek justice after saying the drug damaged their eyesight.
“It started with a distortion of the lines and it got worse,” Catherine D’Andrea told CTV News.
D’Andrea works as an archaeologist and says she now has problems seeing in low light. Color and brightness are diminished for them.
She was first prescribed Elmiron in 2004 for interstitial cystitis, a chronic condition that causes pressure and severe pain in the bladder. Elmiron, commonly known as pentosan polysulfate sodium, is the only oral drug available for this condition and affects hundreds of thousands of Canadians, most of them women.
But after years of taking the medication, D’Andrea says it comes at a cost.
“I’m worried about driving,” she said. “I’m concerned about my ability to go up and down stairs.”
As an archaeologist, she spends a lot of time examining small objects in order to identify them, and her poor eyesight has made this increasingly difficult.
“Another part of my job is going to very rough mountain regions, hiking through uneven terrain. So when you’re looking down and trying to get a good stand it’s difficult when you’re not sure what you are seeing, ”she said.
In August 2020, D’Andrea had a routine appointment with her ophthalmologist who was aware that she had this distorted vision.
“She mentioned that because she saw the drug Elmiron on my file, it could be causing some of these symptoms,” D’Andrea said.
D’Andrea looked for information about the drug once she got off the appointment. After reading it, she decided that same day to stop taking the drug just in case.
Shop owner Lorean Pritchard, who lives in London, Ontario, started taking the drug in 2002. However, she took it off in 2015, mainly because it was expensive.
She now blames the drug for her gradual loss of eyesight.
“I’ve just noticed over time that I wasn’t seeing as clearly as I should,” Pritchard told CTV News.
She said that the characters appeared to be distorted, her eyes were filled with “floaters”, her ability to recognize people was weaker than before, and worst of all, it was becoming more difficult to read.
“I’m a keen reader, that’s my greatest love,” she said.
The biggest impact was on their vision while driving at night.
“I would see some road signs beforehand and test myself,” she said. “It was the bias that told me things weren’t right, even after I had new recipes.”
Sometimes when customers are right in front of her in her store, she can’t see them clearly, she said.
“It was very stressful,” she said.
Pritchard is concerned about her husband’s “burden” if her eyesight continues to deteriorate.
“I won’t have the freedom to drive, I won’t have the ability to enjoy my books. It will affect my entire lifestyle, ”she said.
Although Elmiron is effective in stopping bladder pain, increasing studies have found that it can be linked to damage to the retina of the eyes.
One study found that about a quarter of people who took Elmiron for five years or more had significant retinal damage and found that more significant exposure to the drug was associated with more severe atrophy.
A 2018 study found that the retinal damage associated with Elmiron is distinguishable from hereditary damage.
And a recent report warns that the changes could continue even if patients stop taking the drug.
Dr. Nieraj Jain, assistant professor of ophthalmology at Emory University School of Medicine, was one of the first to set off alarm bells about Elmiron.
He told CTV News that the damage seen in these patients affects delicate cells that determine how they process light.
“These cells are called photoreceptors,” Jain said. “They are light-sensitive cells and the cells under those photoreceptors [are] called the retinal pigment epithelium or RPP. “
“These cells have to work well, they have to be in top shape so that we have a very sharp view that we have. And in patients with this Elmiron-related maculopathy, we see disturbances in pigmentation and degeneration or loss of some of these cells. “
He said that some of these changes in the retina could last up to 20 years long-term, “and maybe in some eyes that are more affected … things can get worse later.”
Warnings have already been issued. Last year, the Canadian Urological Association Journal published an article about the potential risks for long-term users of Elmiron.
In 2019 Canada issued a warning about the medicine, adding the “Risk of pigmentary maculopathy” – a term that refers to a specific type of vision loss – to the “Warnings and precautions for the medicine if it is sold in Canada” section .
Two months ago, Health Canada issued a letter to health professionals providing new information about the potential risks of the drugs.
“These changes can be irreversible, and changes in the retina and vision can progress even after therapy is stopped,” the letter said.
But Pritchard says the advice still doesn’t reach patients. She only found out about the risks of Elmiron by watching CTV news.
Last spring, CTV News aired a story detailing the dilemma faced by many people struggling with painful bladder disease.
“When I saw the CTV segment, it all made sense to me,” said Pritchard.
“I was relieved that I had answers, but then I was very frustrated. Had I been told back in 2002 that there was a chance my eyesight could be compromised and I would lose my eyesight, I probably would not have taken this recipe. “
Both she and D’Andrea have joined a class action lawsuit against the drug makers claiming they have not adequately disclosed the risks of the drug to the public.
Janssen, the manufacturer of the drug, has stated that they will defend themselves and their product against the lawsuit.
“At Janssen, nothing is more important to us than the health and safety of the patients who use our drugs,” they said in a statement to CTV News. “ELMIRON® is an oral drug for the treatment of interstitial cystitis, which causes inflammation and irritation of the bladder wall. We are working closely with Health Canada to ensure that the prescribing information for ELMIRON® adequately reflects the risks and benefits of the medicine, based on the information available to us. We plan to defend ourselves against claims made in this litigation. “
If the class action is successful, the company may have to pay up to $ 500,000 to each affected person.
D’Andrea said that the realization that Elmiron might be behind her loss of vision was sure to be a “life changing moment”.
She said she planned to work as an archaeologist “at least another seven or eight years”, but given her vision, she needed to rethink all of her life plans.
“In my weaker moments, I get angry and upset, but for the most part, I do my best to avoid these obstacles,” she said.
In the meantime, women are telling others about the medication to do at least regular eye exams and watch out for any visual disturbances that could be irreversible.
“In the short term, I think it’s very important to get the word out,” said D’Andrea. “People taking the drug or thinking of taking the drug should see their doctor right away.”