If you have interstitial cystitis (IC), you may have been prescribed Elmiron by your doctor. Patients with IC, also known as painful bladder syndrome, experience severe, chronic pain in the pelvic and bladder area.
In many cases, patients take Elmiron for a longer period of time. Recently, however, studies have connected the IC medication to several eye problems in its users.
In fact, victims of vision damage related to the drug may be eligible to file an Elmiron lawsuit. They may also be entitled to financial compensation for their injuries.
If you’ve been taking Elmiron for quite some time now and you’re worried about the potential risk of a unique eye disease linked to it, you’ve come to the right place.
Continue reading the article to learn more about the potential consequences of long-term Elmiron use, as proven by recent research.
Elmiron, also known as pentosan polysulfate sodium or PPS, is the only oral medication that’s FDA approved to treat bladder pain or discomfort associated with interstitial cystitis. It was originally approved for “compassionate use” by the regulating agency in 1986.
Compassionate drug use means making an investigational, unapproved medical product available to people outside of clinical trials when no other treatment options are present.
In 1996, Elmiron got its official regulatory approval from the Food and Drug Administration (FDA). Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson, manufactures the drug. In 2018, it is estimated that Elmiron made a whopping $150 million in sales for the company.
However, concerns have been growing lately about long-term Elmiron users and their being at an increased risk of developing certain retinal damage that’s only seen in patients who had chronic exposure to the drug. This unique form of maculopathy is called pigmentary maculopathy.
Several studies have detailed this eye disorder in individuals who have taken the drug for an extended period of time.
Emory Eye Center Study
This 2018 study by Dr. Nieraj Jain and his colleagues from the Emory Eye Center in Atlanta, GA, was one of the first medical journal articles that described a potential link between long-term use of PPS and a form of macular degeneration known as pigmentary maculopathy, also called PPS maculopathy.
Six women with IC were observed in this study. They all presented to the researchers’ clinic with pigmentary maculopathy. The patients reported the following symptoms:
- Difficulty reading
- Difficulty adjusting to dim light
- Dimming of vision
- Having trouble seeing things up close
- Vision loss in a certain part of their eye
- Blurry vision
All six patients underwent DNA testing to determine if they had a family history of retinal disease. But it came out negative for all the patients. This means that none of them had genes linked to hereditary retinal damage.
The only thing they all have in common?
They were all taking Elmiron for around 3 to 22 years. The average duration, however, was 16 to 17 years in patients seen with the distinct PPS-induced eye disease.
Eye examinations showed clear pigmentary changes in 10 eyes of 5 patients. Moreover, the drug-induced eye damage also appeared to be dose-related.
Expanded Study from Emory
In may 2019, researchers from Emory conducted another study of ten IC patients who took Elmiron and experienced the macular disease. Among the patients, the most commonly reported symptoms were:
- Difficulty reading
- Trouble adjusting to dim light
Elmiron patients observed in the study took the medication for around 2 to 20 years, with the average duration being 15.5 years. Eye examinations showed the same retinal pigmentary changes as the prior study.
The study authors also noted that their clinic has seen around 156 interstitial cystitis or bladder pain syndrome patients who didn’t take PPS. These individuals didn’t show any signs of pigmentary maculopathy.
Kaiser Permanente Research
After prior reports that pentosan polysulfate sodium (aka Elmiron) may be associated with retinal toxicity, three ophthalmologists from Kaiser Permanente in Northern California conducted a review of their patients.
The researchers observed 140 patients who took Elmiron for a minimum of five years. 91 of the participants agreed to undergo an eye examination. Study authors found that 24% of these patients showed signs of eye damage.
The damage also increased with the amount of Elmiron consumed. This is an unfortunate finding because IC is a chronic condition for which there’s no cure. Therefore, in most cases, patients are put on long-term Elmiron therapy. The amount of medication they take also often increases each year.
Harvest Medical School Study
In November 2019, Dr. Rachel Huckfeldt MD, Ph.D., of the Harvest Medical School Department of Ophthalmology, published the first case study involving an IC patient treated with a low dosage of Elmiron (200 mg per day) for 18 years.
The patient first presented to their clinic at the age of 62. She was experiencing a blurry vision in her left eye as well as difficulty seeing at night. Her symptoms have been occurring for a year already. Doctors saw pigmentary changes in her retina through eye studies.
Six years later, the patient returned and she had a worsening vision in both her eyes. Eye examination found significantly more retina damage. Some two years later and the patient returned to the researchers’ clinic again. This time, more extensive eye damage was noted.
However, doctors found that she was negative for any hereditary disease and the reason for the vision problem she was experiencing cannot be explained otherwise.
After the first study of Elmiron eye damage was released in 2018, this patient’s case was found to be consistent with the retinal pigmentary maculopathy that’s unique to Elmiron users.
The patient confirmed that she stopped taking the IC medication before her second and third visits to the clinic. In the end, the authors raised a growing concern over the progression of pigmentary maculopathy even after patients quit using Elmiron.
Long-Term Effects of Elmiron
Mounting evidence has shown that Elmiron may be linked to a unique eye disorder called retinal pigmentary maculopathy, which can potentially lead to permanent vision loss or blindness.
And while the cause of these pigmentary changes is still unclear, long-term use of Elmiron, as well as increasing doses of the medication, may be some of the risk factors.
The most frequently reported visual symptoms in studies include:
- Difficulty reading
- Slow adjustment to low light environments
- Blurred vision
- Trouble seeing things up close
- Dimming of vision
Unfortunately, many patients in these studies were misdiagnosed at first with pattern dystrophy or age-related macular degeneration. This is a serious concern since unsuspecting patients may develop visual symptoms and eventually experience vision loss because of a failure to timely associate their maculopathy to Elmiron use instead of other age-related eye problems.
Does it work for interstitial cystitis?
IC is a chronic condition that causes bladder and pelvic pain. IC or bladder pain syndrome is common. According to the National Institute of Diabetes and Digestive and Kidney Diseases, it affects around one to four million men and around 3 to 8 women in the United States.
Elmiron doesn’t exactly cure IC, but it provides some relief from symptoms associated with the condition. Manufacturers of the medication tested Elmiron in two clinical trials that involved 2,627 patients.
After three months in the second trial, however, 52 percent of the trial participants, or 1,307, dropped out or were no longer eligible for analysis.
The findings of these trials demonstrated that Elmiron relieved IC pain in many patients. The majority of patients showed pain relief within three months. But a small number of patients took six months to experience pain relief.
However, another study done on a smaller number of participants found that pentosan polysulfate sodium wasn’t beneficial to the majority of IC patients observed.
Can I just stop taking Elmiron?
As with any other medication, you always have to think twice before stopping your drug cold-turkey. There may be many reasons why people choose to stop taking their medications, but abruptly quitting your drug may be dangerous in some cases.
If you’re worried about any possible visual side effects with Elmiron, talk to your physician first. This is because if you decide to go cold-turkey with this medication, its positive effects may wear off and the IC pain you were experiencing before your Elmiron treatment could reappear.
The Bottom Line
Several studies have already surfaced potentially linking Elmiron to permanent vision problems. Since the first report correlating long-term use of Elmiron to a form of macular degeneration known as pigmentary maculopathy was published in 2018, the medical literature investigating potential vision loss and eye damage associated with PPS use continues to grow.
Participants in these studies often report symptoms like difficulty reading, difficulty adjusting to low light environments, and distorted vision, among others.
Unfortunately, in many cases, the conditions of these patients are misdiagnosed as either pattern dystrophy or age-related macular degeneration. This raises serious concerns for healthcare providers and users of the medication, as unsuspecting patients may lose their vision over a failure to attribute their visual symptoms to Elmiron.
But despite the growing evidence between PPS and pigmentary maculopathy, we care about your safety above everything. Before making any decisions about your IC treatment, it’s important to consult your doctor first. Abruptly stopping Elmiron may mean that your IC symptoms could reappear.
How We Can Help
Given the findings of recent research, patients using Elmiron are advised to consult their physician to determine whether the benefits of high-dose use of the medication outweigh its potential adverse effects.
After checking with their prescribing physician, patients are also urged to consult with an eye specialist to undergo annual eye examinations. This is helpful in monitoring for possible eye problems if patients choose to remain on Elmiron.
If you or a loved one suffered from a serious eye condition or other long-term effects of Elmiron, including retinopathy or maculopathy, another option for you is to file an Elmiron eye damage lawsuit.
We know how difficult it might be for you to face an injury while thinking of pursuing legal action against those who harmed you. Rest assured, however, that we will assist you in finding the right Elmiron lawyer who will help you fight for your rights.
Moreover, if we try looking at the bigger picture, filing an Elmiron case also means stopping abusive manufacturers from further harming more patients in the future. Contact us today to find out if you have a case against the makers of the potentially dangerous IC medication.