Common Bladder Medication Elmiron® Linked to Severe Vision Problems

close up view of someone's eye

A common prescription drug used to treat a painful bladder condition is now under fire for allegedly damaging its users’ retinas. For context, the retina is a slim tissue that sits at the back part of the eye. It senses light and, in turn, allows us to see the world.

Commonly prescribed to treat bladder pain and discomfort associated with interstitial cystitis (IC), the prescription drug Elmiron® (pentosan polysulfate sodium, or PPS) is the subject of a recent lawsuit alleging the drug leads to irreversible retinal damage and toxicity.

IC is known more plainly as one of several “painful bladder syndromes,” and, according to the Mayo Clinic, there are more than 200,000 new cases of IC in the United States each year. IC is a chronic condition that causes mild to severe bladder pressure and pain, as well as potential pelvic pain.

Elmiron is the only drug of its kind, and currently the only U.S. Food and Drug Administration-approved medication used by doctors to treat IC. Research by the National Institutes of Health (NIH) estimates that in the U.S. up to 8 million women and 4 million men may have IC.

Given how common the condition is, and how often Elmiron is prescribed to treat it, hundreds of thousands of Americans may be at unknown risk of developing serious damage to their vision.

Elmiron lawsuits are expected to climb as both evidence and complaints about the drug continue to mount. One Elmiron lawsuit, filed against the drug’s manufacturers in March 2020, alleges that the company did not disclose the link between use of Elmiron and the potential risk for serious vision damage.

The Science Behind Elmiron’s Alleged Side Effects

Several scientific studies have been conducted to better understand the alleged connection between use of the drug Elmiron and life-altering, vision-related side effects.

In 2018, a study published in the peer-reviewed journal Ophthalmology found a causal link between Elmiron and the pathological eye disease known as maculopathy, which affects the retina:

“[Our findings] describe a novel and possibly avoidable maculopathy associated with chronic exposure to PPS (Elmiron). Patients reported symptoms of difficulty reading and prolonged dark adaptation.”

Another study, which was presented at the annual meeting of the American Academy of Ophthalmology in San Francisco in October 2019, found that some of Elmiron’s alleged side effects may even go undetected. Symptoms may present themselves as common retinal eye conditions with no presumed connection(s) to the drug.

Further research, conducted by a group of Kaiser ophthalmologists, looked at medical records and identified a heart-wrenching trend: Nearly 25% of patients taking Elmiron were shown to have noticeable retinal damage.

The Kaiser researchers identified 140 patients who had taken around 5,000 Elmiron pills over a span of 15 years. Of the 140 patients, 91 of them voluntarily stepped forward to take new eye exams. When the results came back, 22 patients of those 91 were found to have clear indicators of drug toxicity resulting in visual problems.

Of the patients who took higher doses of Elmiron — 1,500 grams or more — 42% developed visual pathologies. By contrast, around 11% of patients taking between 500-1,000 grams developed visual pathologies.

Reported Side-Effects of Elmiron

The scientific data seems to support what Elmiron users have been saying for many years. Victims of the drug have reported wide-ranging and devastating side effects, including the development of certain eye diseases:

  • Macular degeneration — The deterioration of the center of the retina, resulting in the loss of eyesight in the center of one’s field of vision.
  • Pigmentary maculopathy — A type of macular degeneration that results in a “dark spot” or a series of dark spots in one’s vision while looking straight ahead. These dark spots can expand over time and cause additional visual disturbances.
  • Retinal maculopathy — A type of macular degeneration that affects the smallest part of the retina, where vision is extremely clear and sharp.

In addition, victims have reported the following Elmiron side effects:

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

Given the recent legal action taken against the manufacturers of Elmiron, there may be additional side effects reported in the coming weeks and months as more victims step forward.

Why Patients Are Filing Elmiron Lawsuits

If you are currently taking Elmiron to treat IC, health experts recommend that you diligently schedule and attend annual eye exams. As with any disease, early detection is key in slowing and treating the disease’s progression.

Dangerous drug lawsuits are filed when a prescribed or over-the-counter medication leads to death or an undisclosed disease, complication, or side effects. These lawsuits play a critical role in the justice system by removing or placing warnings on drugs that are linked to potentially deadly or dangerous side effects.

Elmiron is no exception. Its maker, Janssen Pharmaceuticals, Inc. sells at least $150 Million dollars’ worth of it every year.

Patients who have experienced eye problems since they began taking Elmiron never knew there was a vision-impairing risk associated with the medication. Now injured — or worse — these victims are left behind to pick up the pieces, reeling from life-altering diseases and/or side-effects.

If you or a loved one used Elmiron and have since developed a vision impairment, you may be eligible to file an Elmiron lawsuit.

Our case managers are available 24/7 to field questions and provide support. If you are concerned about any vision-related side-effects you have experienced or are currently experiencing, get in touch today for a free, no-obligation legal case review.

Author:Sokolove Law

The Sokolove Law Content Team consists of writers and editors who work alongside the firm’s attorneys and case managers. The team strives to present the most accurate and relevant information for those who need legal help.

Last modified: April 30, 2020

View 7 Sources
  1. Glatter, Robert, M.D. “New Study Adds Concern That Medication to Treat Painful Bladder Condition Linked to Vision-Threatening Eye Condition.” Forbes. Oct. 17, 2019. Retrieved on April 29, 2020, from https://www.forbes.com/sites/robertglatter/2019/10/17/new-study-adds-concern-that-medication-to-treat-painful-bladder-condition-linked-to-vision-threatening-eye-condition/#51ab10ba1bf6

  2. Hicks, Tony. “This Common Bladder Medication May Damage Your Vision.” Healthline. Retrieved on April 29, 2020, from https://www.healthline.com/health-news/common-bladder-medication-may-damage-vision#What-you-should-do

  3. Kimberly Pelczar v. Teva Branded Pharmaceutical Products R&D, et al., 3:20-cv-00406 (Conn 2020).

  4. Mayo Clinic. “Diseases & Conditions: Interstitial Cystitis.” Retrieved on April 27, 2020, from https://www.mayoclinic.org/diseases-conditions/interstitial-cystitis/symptoms-causes/syc-20354357

  5. Nezgoda, J. T., & Jain, N. (2018, December 7). Pigmentary Maculopathy From Chronic Exposure to Pentosan Polysulfate Sodium. Retrieved from https://www.aao.org/interview/pigmentary-maculopathy-from-chronic-exposure-to-pe

  6. Pearce, WA, Chen R., and Jain N. “Pigmentary Maculopathy Associated With Exposure to Pentosan Polysulfate Sodium.” Ophthalmology. Retrieved on April 29, 2020, from https://www.ncbi.nlm.nih.gov/pubmed/29801663

  7. U.S. Dept. of Health and Human Services. “Definitions & Facts of Interstitial Cystitis.” Retrieved on April 29, 2020, from https://www.niddk.nih.gov/health-information/urologic-diseases/interstitial-cystitis-painful-bladder-syndrome/definition-facts