Elmiron/Pentosan Lawsuit: Chronic Bladder Pain Drug Could Lead to Maculopathy, Vision Problems, and Permanent Blindness

Note: Please consult with your doctor before modifying any medications.

If you take, or have taken, Elmiron (pentosan polysulfate sodium, or PPS) for chronic bladder pain, also known as interstitial cystitis (IC), and subsequently experienced vision or eye problems, you may be eligible for a claim against its makers, Janssen Pharmaceuticals.

Our heart goes out to those who have been exposed to the toxicity of the bladder pain drug Elmiron and whose vision then suffered as a result. We know that eyesight can significantly affect one’s quality of life, which is why we’re here to help Elmiron users. We want to help you try to recoup the money you’ve spent on medical bills and account for your other losses because we can’t let billion-dollar companies like Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, get away with not warning people of the harm they may have already caused — and continue to cause.

Doctors now recommend Elmiron users come in at least once a year to have an ophthalmic examination done, with special attention to looking for macular disease.

Symptoms of Maculopathy of Eye Disease

If you’ve been diagnosed with pigmentary maculopathy, or have:

  • Difficulty reading
  • Difficulty seeing objects that are close
  • Difficulty adjusting to low light conditions
  • Losing vision at certain spots
  • Vision dimming or blurring
  • Eye pain
  • Distorted vision

Please call the legal team at the Law Offices of James Scott Farrin at 1-866-900-7078, chat with us, or send us a message here.

Elmiron: Interstitial Cystitis Medication May Be Linked to Maculopathy, Eye Disease, and Deteriorating Vision

Elmiron is a commonly prescribed drug for individuals suffering from interstitial cystitis (IC), also known as chronic bladder pain. Elmiron is also known by its generic name, pentosan polysulfate sodium, or PPS. It was approved by the U.S. Food and Drug Administration (FDA) in 1996 and it is currently the only FDA-approved drug to treat IC.

What is Interstitial Cystitis?

Interstitial cystitis is a condition wherein the walls of the bladder become irritated and inflamed. Because of this, the bladder sends mixed signals to your brain, causing the urge to urinate frequently, but with a small volume of urine actually passed. The exact cause for the condition is not known, but it can greatly impact one’s quality of life.

Symptoms of Interstitial Cystitis

According to the Mayo Clinic, interstitial cystitis symptoms include, but are not limited to:

  • Pelvis pain or pain between the vagina and anus in women
  • Perineum pain (the part between the scrotum and the anus in men)
  • A consistent and urgent need to urinate
  • Frequent urination in small amounts throughout the day
  • Pain during sexual intercourse
  • Pain or discomfort while the bladder and fills and relief after urinating

There is no known cure for interstitial cystitis, but medication and therapies can help. The problem here is that Elmiron and its generic counterpart, pentosan polysulfate sodium, is the only — and by default, the most prescribed — medication to treat the condition.

And the approximately 1 million people affected by IC in the U.S. have been taking Elmiron consistently since it was released.

Elmiron Research Studies Show Strong Link Between Prolonged Elmiron Use and Pigmentary Maculopathy

Evidence and available data is now mounting to support the hypothesis that Elmiron may cause some users to develop maculopathy, retinopathy, and other eye conditions that seriously deteriorate vision.

The Interstitial Cystitis Network, a website dedicated to supporting the IC community, provides an easy, printable fact sheet (which you can find here) for you to give to your doctor if you take Elmiron and have suffered vision or eye problems.

In 2018, Dr. Nieraj Jain, Assistant Professor of Ophthalmology at the Emory University School of Medicine Eye Center, reported that six patients who had been taking Elmiron consistently for 15 years had developed some abnormal changes in the macula. The patients reported they had visual changes and difficulty reading, especially under low light conditions.

The macula is the part of the eye that delivers clear, central vision. There was nothing in these patients’ medical history to indicate it was a hereditary issue, and the one thing linking the six patients was the prolonged use of Elmiron to treat IC. Dr. Jain rang the alarms to alert the medical and pharmaceutical industries of the potential link. You can read the study’s details here.

Dr. Jain and his colleagues brought their findings to Janssen Pharmaceutical’s attention, but even now, maculopathy is still not included as a potential side effect on the drug’s list of side effects and health warnings. This means people continue taking Elmiron without knowing that their vision problems could be attributed to the ocular toxicity of the drug.

  • In April 2019, Dr. Jain and his research colleagues followed up with another study, this time with 10 patients between 38-68 years of age, which found similar macular issues. You can read the study here.
  • In October 2019, Dr. Robin A. Vora, Chair of Ophthalmology at Kaiser Permanente and her colleagues released a study showing the results of their search through 4.3 million Kaiser patients who could be affected by Elmiron’s side effects. They found 140 patients who had each taken about 5,000 Elmiron pills over the course of 15 years. 91 of those 140 patients were evaluated for eye and vision abnormalities, and of those 91, 22 were found to have clear signs of drug toxicity. The toxicity was higher in patients who took more Elmiron pills.

According to Dr. Vora, "It's unfortunate. 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."

  • In November 2019, Drs. Rachel M. Huckfeldt and Demetrios G. Vavvas published a case report where they presented the case of a patient who had maculopathy associated with pentosan, and whose condition has continued to get worse 6 years after stopping use of Elmiron. You can read the study here.

North Carolina Lawyers Ready to Help Elmiron Users Who Suffered Vision Damage or Loss

If you are one of the people who have suffered vision problems or vision loss after taking Elmiron or its generic pentosan, we want to hear from you. Let us help you try to fight for just compensation for the harm they may have inflicted on you. We may be able to help you recover compensation for past and future:

  • Lost wages
  • Medical expenses from Elmiron or pentosan-related injuries
  • Loss of earning capacity
  • Pain and suffering
  • Punitive damages

The Law Offices of James Scott Farrin is taking cases for Elmiron-related injuries. Get in touch with someone from our experienced team at 1-866-900-7078, chat with us, or send us a message here to set up a confidential, free, no-obligation case evaluation. We don’t get paid an attorney’s fee unless we help you recover compensation.

The Law Offices of James Scott Farrin consults with a national network of attorneys on product liability, defective drugs, and defective products cases in an attempt to provide the best representation we can for our clients. Depending on the details of your case, our firm will likely refer your matter to another law firm with which we associate. We will only do this if we believe it is in your best interests and if you agree.