Interstitial Cystitis, Elmiron, and Pigmentary Maculopathy

Elmiron is a drug used to treat interstitial cystitis. Most of you don’t know what interstitial cystitis is, and that’s a good thing. Unless you are a urologist, you wouldn’t have reason to know about the condition . . . unless you suffer from it. But if you suffer from interstitial cystitis, you probably know a lot about it. In this post I am going to describe the condition, then discuss Elmiron, the only FDA-approved drug to treat the condition, and finally highlight the latest studies indicating that Elmiron may cause pigmentary maculopathy, which can cause vision loss or even blindness.

Interstitial Cystitis

Interstitial cystitis is a painful bladder condition. Interstitial means situated within but not restricted to one organ or tissue, especially fibrous tissue. Cystitis means an inflammation of the urinary bladder. Urinary tract infection is one example of cystitis. Interstitial cystitis causes the walls of the bladder to become irritated or inflamed. This leads to bladder pressure, bladder pain, and pelvic pain. Interstitial cystitis is one of several conditions labelled painful bladder syndrome.

When your bladder is full (and working properly) it sends a signal through the pelvic nerves to your brain to let you know that you need to urinate. When you suffer from interstitial cystitis, these signals don’t work properly, and several symptoms may result, including:

The sensation that you need to urinate more often;
Frequent trips to the bathroom to urinate (often small amounts per visit);
Pain in the bladder, pelvis, or abdomen;
Frequent urinary tract infections (UTIs);
Pain during intercourse;
Pain near the perineum (near the anus);
Abdominal pressure and bloating;
Menstrual cramps.

A few factors that may cause interstitial cystitis include defects in the lining of the bladder, some of which may cause bladder leakage. Other factors could be an autoimmune reaction, allergies, or infection.

Women are more likely to develop interstitial cystitis than men. There is no cure for interstitial cystitis, but there are therapies, including physical therapy, nerve stimulation, and modification of diet. There is also one medication approved by the FDA to treat interstitial cystitis: Elmiron, made by Janssen Pharmaceuticals.

Elmiron

Elmiron is the brand name for pentosan polysulfate sodium (PPS). Elmiron or PPS allegedly provides a protective coating to a damaged bladder wall. It may coat or even repair the lining of the bladder, potentially reducing leakage and related adverse symptoms. Elmiron was first approved in 1996 to treat interstitial cystitis and painful bladder syndrome.

There are side effects. Patients have reported diarrhea, heartburn, stomach pain, rash, headache, and insomnia. Unfortunately, as I mentioned in a previous post, recent studies indicate a link between Elmiron and vision loss, specifically a retinal condition known as pigmentary maculopathy.

Pigmentary Maculopathy

The macula is the central area of the retina, at the back of the eye. This is the area that receives images and color. It is where most of the “action is” with respect to quality vision. The macula allows us to see with clarity, and it also supports sharp color vision. When the macula is damaged in some way, our vision is also damaged. Pigmentary maculopathy represents several conditions that can affect the central part of the retina or macula. Pigmentary maculopathy may cause a dark spot in a person’s vision that gets worse over time. It can also cause blurred vision, flashing lights, vision distortions, light sensitivity, and other vision problems.

Recent studies show that Elmiron may cause a buildup of pentosan polysulfate sodium (PPS) in the macula, which can result in irreversible retinal damage, which means irreversible vision problems. In some cases, pigmentary maculopathy can lead to blindness.

If you have taken Elmiron to treat interstitial cystitis for an extended period and now have vision problems, you need to seek medical attention as soon as you can. If you would like to discuss whether you may have a case against Janssen Pharmaceuticals, the maker of Elmiron, give me a call: 919.546.8788.

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