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doctor clicks on the shield in which the bladder is located surrounded by medical icons

What Is Elmiron Used to Treat?

Elmiron is a prescription medication used to treat interstitial cystitis (IC), also known as painful bladder syndrome. It is the only oral treatment approved by the U.S. Food and Drug Administration (FDA).

Recent studies have found a connection between Elmiron and severe vision problems, particularly a disease called pigmentary maculopathy affecting a part of the eye called the retina. The retina is responsible for sensing light and sending signals to the brain that makes it possible to read, drive, and recognize faces. There are several types of maculopathy, or macular degeneration, and most are related to aging.

However, the sole cause of pigmentary maculopathy appears to be Elmiron itself, as this type of maculopathy results from a buildup of the medicine’s active ingredient, pentosan polysulfate sodium. Like all maculopathy, there is no cure, and many patients experience permanent eye damage and/or vision loss.

Hundreds of interstitial cystitis patients who developed pigmentary maculopathy after using the drug began filing Elmiron lawsuits against its manufacturer, Janssen Pharmaceuticals, in 2020.

What Is Elmiron (Pentosan Polysulfate Sodium)?

Interstitial cystitis is usually characterized by swelling and scarring of the bladder walls, leaving them vulnerable to harmful irritants in urine. Elmiron builds a layer on the bladder wall to protect it from these irritants. It is also a blood thinner, so increased bleeding or bruising is a common side effect. Doctors have been prescribing it for millions of IC patients 16 years or older since 1996. Mild IC can usually be resolved through lifestyle changes, while severe cases require medical intervention. Elmiron is generally very effective for patients with moderate cases.

Common side effects of Elmiron are hair loss, nausea, headache, rash, trouble falling asleep, upset stomach and diarrhea. More serious complications include: 

  • Increased bruising
  • Nosebleeds, bleeding gums and bloody stool
  • Changes in mental acuity/mood swings
  • Heartburn
  • Difficulty swallowing
  • Fatigue
  • Rapid heartbeat/shortness of breath
  • Severe allergic reactions

Doctors have warned patients about these possible side effects for decades. Still, most didn’t know Elmiron could cause eye disease until a group of ophthalmologists wrote a letter to the Journal of Urology in 2018. Many of their patients, none of whom had a family history of retinal disease, developed pigmentary maculopathy after more than a decade of Elmiron use. Their findings spurred more studies around the country, including one by Kaiser Permanente in 2019, showing that 25% of observed Elmiron users experienced eye damage.

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Janssen Pharmaceuticals added a precaution about pigmentary maculopathy and other eye problems to Elmiron’s website in the summer of 2020, but this warning came too late for many IC patients. 

What is Interstitial Cystitis (IC)?

Interstitial cystitis is a painful, incurable condition that can make daily life impossible to enjoy. In severe cases, sufferers may take 40-60 trips to the bathroom every day. They have trouble sleeping, as the urge to urinate is constant. The exact cause of the disorder is unknown.

Women are much more likely to contract IC than men, which rarely develops before age 30. Those with pre-existing chronic pain disorders such as IBS or fibromyalgia are also at higher risk.

When IC first presents, it can often be confused with an easily-cured urinary tract infection. The following symptoms can be a signal that bladder discomfort is more serious:

  • Pain in the pelvis or perineum
  • Persistent urge to urinate
  • Urinating in small amounts constantly throughout the day
  • Pain or discomfort while the bladder fills up, and relief after emptying
  • Painful sexual intercourse

Diagnosing interstitial cystitis can include keeping a diary of bladder input and output, a pelvic exam and urine test, a cystoscopy (a small camera inserted in the urethra) and a biopsy.

Possible treatments include nerve stimulation, medications instilled in the bladder, and of course, Elmiron.

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Surgery is generally ineffective as removing the bladder can cause more complications than relief.

While Elmiron is certainly the simplest IC remedy, patients must weigh its convenience against the emerging risks of degenerative eye disease.

Are There Alternatives to Elmiron?

While Elmiron is the only FDA-approved treatment for interstitial cystitis, some alternatives exist, although they may be less effective for moderate to severe cases.

Adopting healthy lifestyle changes, such as staying hydrated, quitting smoking and exercising, can improve IC symptoms. Avoiding the most common bladder irritants – the four C’s (carbonated beverages, caffeine, citrus and Vitamin C) – can also ease the pain.

Bladder and bowel training, or training yourself to use the bathroom at timed intervals that you gradually spread out, is another solution.

Others include physical therapy, over-the-counter pain relievers, and distending the bladder with water. Failing all of these conservative treatments, doctors may recommend surgery to enlarge the bladder or reroute urine flow.

No single treatment works for everyone – a combination is usually required. If you’re experiencing symptoms of interstitial cystitis, see your healthcare provider for your best options.