The Dangers of Elmiron and Retinal Damage: What Do You Need to Know?

We’ve all seen the cross-legged, back-and-forth dance of someone who just has to go pee. Conversely, all of us have felt the discomfort of a full bladder when you’re seemingly miles away from the nearest bathroom. For those who have been diagnosed with interstitial cystitis (IC), this feeling is all too common.

For the majority of IC patients, the quickest form of treatment is a prescription for Elmiron. The pain-relieving drug is currently the only approved oral medicine for IC, and comes with relatively fleeting side effects– nausea, diarrhea, dizziness, etc.

But what about permanent damage to your retina and vision loss? For the first 24 years of the drug’s sales, this warning was nowhere to be found. Now, as longtime users are facing serious complications, many could be entitled to compensation.

What is Interstitial Cystitis?

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Interstitial Cystitis (IC), also known as painful bladder syndrome, is a chronic condition which, as you might suspect, causes bladder pain and discomfort. Other symptoms can include:

Pelvic pain
Frequent urination
Pain or discomfort during sexual intercourse

These symptoms vary greatly between patients, ranging from mild to severe– they can also change over time, with periodical lulls and flare-ups. The condition is considered to be relatively common, with over a million cases in the US. Women are diagnosed about twice as often than men, and most patients are aged 30 and older.

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There is currently no known definitive cure for IC, and treatments are wide-ranging; non-invasive methods include special diets and therapies, and prescription treatments involve antihistamines, antidepressants, and most notably pentosan polysulfate sodium (PPS). PPS is prescribed in the form of the drug Elmiron.

What is Elmiron?

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Elmiron is by far the most common medical treatment for IC, as it’s the only oral drug approved for it, and it is not available in a generic form. Essentially, it works by forming a protective coating on the inner lining of the bladder to help protect against inflammation from irritants in one’s urine. It doesn’t effectively cure the condition, but steady users can see some improvement in pain relief over time.

The drug, which is manufactured by Janssen Pharmaceuticals, was approved by the FDA in 1996 under the Orphan Drug Act, which gives special incentives to manufacturers of drugs that treat rare diseases. In the decades since its release, because of Elmiron’s accessibility and its monopoly on IC medications, it is believed that hundreds of thousands of patients have been exposed to the drug.

Issues With Elmiron and Why Patients are Suing: A Brief Timeline

There were little to no issues in the first 20-plus years of the drug’s sales, until 2018, when a groundbreaking study from Emery Eye Center in Atlanta posited that prolonged exposure to PPS (Elmiron) can lead to a unique form of maculopathy.

Maculopathy is a progressive condition which affects a specific part of your retina called the macula– the part of your eye where vision is keenest. Patients with maculopathy typically experience the following:

Blurry or dark spots in the center of your vision
Difficulty adjusting to low-light environments
Difficulty reading or focusing on object details
Distorted objects and lines

The discovery of maculopathy in Elmiron users was important for two reasons: the first is that potential eye damage was never listed on Elmiron’s possible side effects; the second was that all of the studied patients tested negative for other possible causes of maculopathy. Essentially, it verified that extensive Elmiron use was the root cause.

After the publication of Emery’s study, researchers at Kaiser Permanente in California were frightened by the results and decided to investigate their own patient population. Their findings were all the more damning– a report in January of 2020 revealed that for patients who had ingested over 1,500 grams of Elmiron (about 15 years’ worth), a whopping 42 percent had developed definite signs of drug toxicity.

In response to these findings, the FDA announced on June 16th, 2020 that Janssen Pharmaceuticals had made changes to the Elmiron label to include “pigmentary changes in the retina” in the “Warnings and Precautions” and “Adverse Reactions” sections of the packaging. Many longtime users have begun to file lawsuits against Janssen for their negligence in warning patients of potential risks, and for only acknowledging hazards after decades of production.

Am I Eligible for an Elmiron Lawsuit?

As of May 2021, Elmiron litigation has advanced to the point where certain case criteria are being established. All potential Elmiron claimants should note the following:

Documented Use History: Claimants should be able to demonstrate prolonged use of Elmiron, either through prescription records or otherwise. Generally, at least one year of use is ideal for a strong claim, but this is not required.
Ocular Difficulties: Next, the plaintiff must show that Elmiron use was detrimental to the health of their eyes and vision. This can be presented in multiple ways, such as:
Macular degeneration (MD)
Age-related macular degeneration (ARMD)
Retinal Maculopathy
Retinal Pigmentary Endothelium Injury (RPE)
Other types of maculopathy or retinal damage

Without a confirmed diagnosis, clients should have at least consulted a physician for symptoms such as general vision loss, trouble reading or focusing, problems adjusting to low light, or glare or light sensitivity. Conversely, a case will be considered especially strong if the claimant has an actual diagnosis that is confirmed by Fundus Autofluorescence Imaging (FAF), Near-infrared Reflectance (NIR), Optical Coherence Tomography (OCT), or Heidelberg Multicolor.

Contact Trusted Elmiron Attorneys

If you’re struggling with retinal and vision damage after prolonged exposure to Elmiron, call the experienced Elmiron attorneys from Van Law Firm now for a free and confidential consultation to discuss the eligibility of your claim.

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