Elmiron is the only FDA-approved medication known to treat a painful bladder condition called interstitial cystitis. Despite this, it has been discovered that use of the drug may be connected to eye problems among patients, according to various reports of retinal problems occurring after long term use of the drug, among other potential side effects of Elmiron.

What Is Elmiron?

Elmiron (pentosane polysulfate sodium) is an oral medication used to treat the pain and discomfort associated with the bladder disorder interstitial cystitis. Interstitial cystitis (bladder pain syndrome) involves pain and/or pressure in the area of the bladder without a clear cause. Pain from this condition can range from mild to severe.

Although the cause of interstitial cystitis is unknown, doctors have theorized that the bladder condition may be caused by mixed up signals between the bladder and brain. As a result, the brain may register pain and the need to urinate, according to this theory.

Unfortunately, there is no cure for interstitial cystitis. Treatment may include physical therapy for pelvic pain and pain management. In severe cases, nerve stimulation, bladder distention (stretching of the bladder), bladder instillation (administering medications into the bladder), and even surgery may be used to manage the condition.

Treatment for the condition may also include medications such as NSAID pain relievers, antihistamines, and even tricyclic antidepressants to help relax the bladder and manage painful symptoms.

Elmiron may work by forming a layer on the wall of the bladder to protect it from harmful or irritating substances; doctors don’t know why interstitial cystitis happens, so this is still a theory.

The medication should be taken on an empty stomach—at least an hour before or two hours after a meal.

What Are Possible Side Effects of Elmiron?

Elmiron is a weak blood thinner, and can therefore increase a person’s risk of bruising and bleeding. There are a number of common side effects associated with the interstitial cystitis drug, including:

• Diarrhea.
• Hair loss.
• Nausea.
• Headache.
• Stomach upset/pain.
• Abdominal pain.
• Dizziness.
• Depressed mood.
• Itching skin or rash.

More severe complications of Elmiron include:

• Unusual bruising or bleeding.
• Mental/mood changes.
• Heartburn.
• Discomfort from swallowing.
• Signs of infection.
• Yellowing eyes/skin (jaundice).

Unfortunately, Elmiron may be associated with some serious vision problems as well.

Can Elmiron Cause Eye Problems?

Elmiron, while treating interstitial cystitis, may be linked with a rare eye condition known as pigmentary maculopathy, recent reports indicate. Maculopathy is a pathological condition or disease affecting the macula, the portion of the retina where vision is most developed.

Pigmentary maculopathy specifically involves small changes in the pigment on the macula. It occurs after long-term treatment with Elmiron, according to reports. In order to detect this condition, advanced imaging is required. In some cases, consulting with a retina specialist may be necessary.

There are a number of symptoms linked with pigmentary maculopathy, including the following:

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

A study by the American Academy of Ophthalmology, released in November 2018, noted a connection between long-term treatment with Elmiron and eye problems. This study detailed the experiences of six patients who had been taking Elmiron for IC for an average of 15 years. These patients reported difficulty reading and seeing, especially in low light situations. After further investigation, researchers found that these patients had changes in their macula—the part of the retina responsible for clear central vision.

A second Elmiron study by the same researchers, released in May 2019, detailed additional patients’ experiences. Through this study, researchers found that the interstitial cystitis drug was linked with “potentially avoidable retinal degeneration phenomenon associated with chronic [Elmiron] exposure,” as well as “structural changes” to the pigmented retinal layer. It is unclear as of yet if simply stopping the medication would be enough for the retinal condition to improve.

New Research Explores Potential Eye Damage

The 2018 study showing the potential connection between Elmiron and eye damage led to further studies completed by a group in California. The initial research was presented at the 2019 annual meeting of the American Urological Association.

Researchers from Kaiser Permanente in Northern California wanted to further explore how this issue was affecting patients in their own community.

Their research found that 25% of the patients who had significant exposure to Elmiron showed strong evidence of retinal damage. The primary concern was that the toxicity from the medication could mimic other retinal conditions like patterned dystrophy or age-related macular degeneration. The most recent research study was presented at the 2019 annual meeting of the American Academy of Ophthalmology.

Progressive vision loss could lead to permanent blindness and Kaiser Permanente’s analysis of its own database found 140 patients who had each taken approximately 5,000 pills over a 15-year period. In total, 91 of the 140 were evaluated and 22 of them showed clear signs of drug toxicity.

Drug toxicity is difficult to diagnose when patients are taking multiple medications. As additional medications are added, the chances for side effects increases.

Since Elmiron-related eye problems may be similar to other retinal conditions, a patient might not make the connection between the drug and the most recent side effects.

“It’s unfortunate,” researcher Dr. Robin A. Vora said 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.”

In November 2019, other researchers analyzed data from a large database of medical claims from 2002 to 2016. Analysis of this database found that patients who took Elmiron had a “significantly increased” risk of developing atypical maculopathy after seven years of treatment. Specifically, 103 and 87 patients on Elmiron were diagnosed with maculopathy and AM after five and seven year follow ups, respectively.

What Does the FDA Say About Elmiron and Eye Problems?

The U.S. Food and Drug Administration (FDA) released new guidelines regarding the labeling of Elmiron on June 8, 2020. Updates were made to the Warnings and Precautions section and to the Adverse Reactions section of the drug’s labeling.

The FDA warns that pigmentary maculopathy may occur in patients who take Elmiron for three years or longer, but they have seen cases reported with a shorter amount of time using the drug. Even though the reasons why are unclear, the cumulative dose seems to affect the outcome of visual disturbances.

The government organization indicates patients should be aware of visual changes such as difficulty reading, slowed adjustment to environments with reduced lighting, and blurry vision.

Any patient who has a family history of hereditary pattern dystrophy (macular problems that are inherited through genes) should consider having a genetic test before starting Elmiron, suggests the FDA. A patient with pre-existing eye conditions could benefit by having a full baseline retinal exam every six months or so throughout treatment and even after stopping Elmiron. Recommended retinal tests include:

• Fundoscopic photography: This exam allows the doctor to see the retina, which Stanford Medicine explains is the only part of the central nervous system that can be seen from the exterior of our bodies.
• Ocular coherence tomography: This non-invasive imaging exam uses light waves to take pictures of each individual layer of the retina, which allows the doctor to determine the thickness.
• Auto-fluorescence imaging: This test uses the retina’s own natural fluorescent properties to see the retina’s health status. A special blue light that’s shined upon the retina can cause some cells to glow without the use of any dyes and allows the doctor to see more defined patterns.

Can I File an Elmiron Lawsuit?

If you have suffered from vision problems after taking Elmiron, you may be able to join a class action lawsuit investigation and pursue compensation. Filing a lawsuit can be daunting, so Top Class Actions has laid the groundwork by connecting you with an experienced attorney. An attorney can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.