Elmiron®: Why Is This Common Bladder Medication Causing Vision Problems?

a woman holds a pill

The only known medical treatment for interstitial cystitis (IC) is increasingly linked to severe vision problems in patients who use the drug. The drug is called Elmiron®, and the company that makes it failed to disclose any such side effects, despite raking in millions of dollars in sales promoting it.

Recent studies have shown that up to a quarter of patients who take Elmiron long-term suffer retinal damage, including vision loss.

What Is Elmiron?

Elmiron is a drug used to treat bladder problems caused by interstitial cystitis (IC). Patients with IC typically experience bladder pain, discomfort, and the need to urinate often.

Elmiron, also known by its generic name pentosan polysulfate, is believed to work by protecting the bladder walls from irritants in the urine, thereby relieving pain and discomfort.

However, there is some conflicting evidence as to its effectiveness, and the variety of side effects associated with the drug raises questions as to whether it should be on the market at all.

Does Elmiron Cause Vision Problems?

Current scientific evidence suggests that, yes, Elmiron may cause vision impairment in some patients over time. The problem is that the company that makes the drug, Janssen Pharmaceuticals, is not convinced of the science — at least not publicly.

In June 2020, a warning was issued detailing the drug’s link to certain vision problems. Specifically, the warning identified pigmentary changes in the retinas of patients who had been taking Elmiron for over 3 years.

This condition is also known as pigmentary maculopathy, and can result in difficulty reading, slow adjustment to low or reduced light environments, and blurred vision. According to available data, it is believed that the risk of developing vision problems increase with dose and length of use.

But the experience of several Elmiron users tells a more serious story. A study performed by ophthalmologists at Kaiser Permanente in Northern California found as many as 24% of patients showed signs of retinal damage after 5 years of Elmiron use.

Likewise, patients who have filed suit against Janssen, which is a subsidiary of Johnson & Johnson, claim they’ve suffered permanent vision damage stemming from their use of Elmiron.

Specifically, users have suffered one or more of the following:

  • Macular degeneration
  • Pigmentary maculopathy
  • Retinal maculopathy

None of these side effects was ever listed or included on any labels or marketing materials for Elmiron. In response to these complaints, Janssen Pharmaceuticals has been evasive or dismissive. In its official literature, the company lists several side effects as occurring in less than 1% of Elmiron users.

These side effects include:

  • Conjunctivitis
  • Optic neuritis
  • Amblyopia
  • Retinal hemorrhage

That assessment is incompatible with the scientific research, which revealed that up to 1 out of every 4 long-term Elmiron users experiences vision problems.

The tragedy here is that Elmiron is intended to be used indefinitely, as it is used to alleviate the symptoms of a chronic disease with no known cure.

For pharmaceutical companies like Jannsen, that is the ideal patient relationship because it translates to long-term dependence on one of their key pharmaceutical products.

“It’s unfortunate,” said Dr. Robin A. Vora, MD, an ophthalmologist at Kaiser Permanente, in a press release. “You have a patient with a chronic condition like interstitial cystitis, for which there is no cure and no effective treatment. They get put on these medications because it’s thought to have few side effects and few risks, and no one thinks about it again. And year after year, the number of pills they’re taking goes up and up.”

What Are the Side Effects of Elmiron?

These side effects have been reported by long-term users of Elmiron:

  • Blurred vision
  • Difficulty reading
  • Distorted vision
  • Eye pain
  • Issues adjusting to darkness
  • Vision disturbances
  • Vision loss

Elmiron has also been known to cause a range of other side effects. Categorized as a “weak” blood thinner, the drug can also increase the risk of bruising and bleeding, which itself can lead to severe health problems in some patients.

Other known side effects include:

  • Abdominal pain
  • Bleeding
  • Bruising
  • Changes in mental state
  • Diarrhea
  • Hair loss
  • Headaches
  • Nausea

For more information about side effects, or if you are experiencing an unlisted side effect you believe may be connected to your use of Elmiron, contact Sokolove Law today. Our team of Case Managers are available 24/7 to answer your questions and provide support.

Work With a Law Firm That Specializes in Dangerous Drugs — Sokolove Law

Elmiron lawsuits allege that the drug maker, Janssen Pharmaceuticals, did not disclose the link between Elmiron and serious vision damage and failed to warn patients about this risk.

Given that Elmiron sales amount to at least $150 Million per year and that the drug stands alone as the only IC prescription on the market, many thousands of Americans may be at risk of developing a serious eye condition.

If you — or a loved one — are experiencing vision problems and currently take Elmiron, or have taken it in the past, contact Sokolove Law today for free, no-obligation legal consultation.

Note: Do not change medications without first consulting your doctor.
All brands are trademarks of their respective companies.

Author:
Sokolove Law Team

Contributing Authors

The Sokolove Law Content Team is made up of writers, editors, and journalists. We work with case managers and attorneys to keep site information up to date and accurate. Our site has a wealth of resources available for victims of wrongdoing and their families.

Last modified: July 11, 2022

  1. WebMD, “Elmiron Oral : Uses, Side Effects, Interactions, Pictures, Warnings & Dosing.” Retrieved from https://www.webmd.com/drugs/2/drug-14085/elmiron-oral/details. Accessed on Nov. 3rd, 2020.
  2. Janssen Pharmaceuticals, “ELMIRON®-100 MG (PENTOSAN POLYSULFATE SODIUM) CAPSULES PRESCRIBING INFORMATION.” Retrieved from http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/ELMIRON-pi.pdf. Accessed on Nov. 3rd, 2020.
  3. National Law Review, “Elmiron Litigation and Vision Impairment and Damage.” Retrieved from https://www.natlawreview.com/article/elmiron-litigation-continues-what-they-still-aren-t-telling-you. Accessed on Nov. 3rd, 2020.
  4. ScienceDaily, “More evidence linking common bladder medication to a vision-threatening eye condition.” Retrieved from https://www.sciencedaily.com/releases/2019/10/191012141218.htm. Accessed on Nov. 3rd, 2020.
  5. WRAL, “Elmiron drug linked to vision problems in women.” Retrieved from https://www.wral.com/elmiron-drug-linked-to-vision-problems-in-women/19313848/. Accessed on Nov. 3rd, 2020.
  6. INTERSTITIAL CYSTITIS NETWORK, “New Study Finds 24% of Long-Term Elmiron Users Showed Eye Damage.” Retrieved from https://www.ic-network.com/new-study-finds-25-of-long-term-elmiron-users-showed-eye-damage/. Accessed on Nov. 3rd, 2020.