Elmiron (pentosan polysulfate sodium), a prescription medication used to treat bladder conditions, has been linked to an eye disease that can cause vision loss and other eye problems. You may qualify for an Elmiron lawsuit if you took pentosan polysulfate sodium and were diagnosed with eye issues such as macular degeneration or pigmentary maculopathy
Doctors across the country have documented cases of pigmentary maculopathy, or retinal injury, in patients who took Elmiron for long periods of time.
These cases were first documented in 2018, but Elmiron has been prescribed for decades without any warning about eye damage. The drug’s labeling was updated in 2020 to reflect the risk of pigmentary maculopathy from long-term use of Elmiron.
Plaintiffs claim in Elmiron lawsuits that this new warning is too little, too late. They’re blaming the drug’s manufacturer for their vision problems and seeking compensation for their injuries.
Speak with an attorney and find out if you qualify for legal action during a free case review.
Interstitial cystitis (IC) is a chronic condition of the bladder that causes pressure, pain, the frequent urge to urinate, and painful or uncomfortable intercourse. Doctors aren’t exactly sure what causes IC. They think patients may have a defect in the protective lining (epithelium) of the bladder that allows toxic substances in urine to irritate the bladder wall.
Symptoms of IC can range in severity and may be intermittent. IC affects women more often than men. New research indicates that the condition is much more prevalent than previously thought. As many as 3 to 8 million women and 1 to 4 million men may suffer from IC, according to the Interstitial Cystitis Association.
Pentosan Polysulfate Sodium First Drug Approved For IC
Pentosan polysulfate sodium (PPS), sold under the brand name Elmiron, has been used to treat IC since 1986. Elmiron was approved by the FDA in 1996 and was the first drug approved for IC treatment. Before then, Elmiron was given to patients with IC through a compassionate use program.
The manufacturer of Elmiron, Janssen Pharmaceuticals, markets Elmiron as the “only oral medication FDA approved to treat the bladder pain or discomfort of interstitial cystitis.” Another medication, RIMSO-50 (dimethylsulfoxide), is administered to patients via intravesical therapy.
Elmiron Mechanism of Action Is Unknown
Janssen Pharmaceuticals admits that “It is not known exactly how Elmiron works.” A mild anticoagulant, or blood thinner, Elmiron is thought to work by adhering to the bladder’s epithelium and preventing potentially irritating substances in the urine from reaching the bladder wall. However, there is evidence that Elmiron has limited efficacy. One study found that a group of patients receiving pentosan polysulfate sodium showed no treatment effect compared to a placebo group.
Elmiron and Vision Problems
Elmiron is not a pain reliever and must be taken regularly for relief as prescribed. Because there is no cure for IC, this can result in patients taking Elmiron for many years. Over time, research shows, this can lead to PPS toxicity and resulting vision problems.
Long Term Use of Elmiron Linked to Eye Damage in 2018
Eye damage associated with Elmiron was first discovered by researchers at the Emory Eye Center in 2018. A case series of six patients describes how the patients had symptoms that included difficulty reading, slow adaptation to darkness, dimming of their vision, trouble with near vision, vision loss, and distorted vision.
All of the patients underwent rigorous diagnostic imaging and genetic testing to determine if they had any genes associated with hereditary retinal loss. None of them did. What they did have in common is that all were suffering from IC, and all were long term Elmiron users.
Examination of the patients’ eyes showed structural changes in the retina. The doctors suggested that the changes may be the result of retinal cells accumulating PPS, or toxic PPS metabolites, over time. They concluded that, “Clinicians should be aware of this condition because it can be mistaken for other well-known macular disorders, such as pattern dystrophy and age related macular degeneration.”
Fittingly, one of the patients from this study went on to file an Elmiron lawsuit against Janssen. Her lawsuit claims that the manufacturer failed to warn of the risk of macular degeneration and blindness.
Further Studies Confirm Initial Research
In 2019, the same team of researchers from Emory Eye Center published a new study of ten interstitial cystitis patients who took Elmiron and developed pigmentary maculopathy. This study and subsequent studies have produced a number of significant findings, including:
- Symmetric pigmentary changes in the retina (i.e., the retinal changes affect both eyes of the patient).
- Eye damage appears to increase with the amount of Elmiron taken. One study compared IC patients with maculopathy and IC patients without maculopathy found that the former had ingested an average of 14,067 Elmiron capsules, compared to 10,561 capsules among those without maculopathy. A study from Kaiser Permanente researchers found that the rate of PPS toxicity rose with the amount of drug consumed.
- Taking Elmiron for long periods of time also appears to affect the development of eye problems. Emory researchers found significantly increased odds of developing maculopathy at 7 years of Elmiron use, compared to 5 years of use. According to another study, IC patients with maculopathy reported taking Elmiron for 3 years to 22 years, with a median duration of 16 – 17 years.
- It’s unclear whether the development of pigmentary maculopathy is halted or altered when you stop taking Elmiron. At least one case report found that Elmiron-associated maculopathy continued to progress for years after the patient discontinued the medication.
While research is still being done on the possible link between Elmiron toxicity, IC, the bladder, and eye health, a group of doctors recently wrote in Retina Today that, “Mounting evidence links chronic exposure to pentosan polysulfate sodium with the development of a novel pigmentary maculopathy.”
The doctors said that the current findings “represent a major patient safety issue.” According to the doctors, many patients who took Elmiron and experienced vision side effects may have been misdiagnosed with age-related eye problems, which “may have led to preventable, irreversible vision loss.”
Have you been diagnosed with maculopathy after chronic exposure to pentosan polysulfate sodium? Contact Milberg for a free Elmiron lawsuit review.
Did Janssen Pharmaceuticals Fail to Warn About Elmiron Vision Problems?
In June 2020, the U.S. Food and Drug Administration (FDA) approved changes to Elmiron’s safety labeling. The new label, added nearly 24 years after Elmiron was initially approved in September 1996, states that:
Pigment changes in the retina of the eye (also referred to as pigmentary maculopathy in medical journal articles) have been reported with long-term use of Elmiron. Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor.
Early Elmiron Study Reported Vision-Related Side Effects
This is not the first time that serious eye-related side effects have been reported with Elmiron. An early Elmiron study of 2,500 patients who received the drug for up to four years reported adverse events that included optic neuritis (damage to the optic nerve), amblyopia (lazy eye), and retinal hemorrhage. These side effects are included on Elmiron’s label, but they’re listed in the “less than 1%” category.
Do I Qualify For an Elmiron Lawsuit?
Generally, to be eligible for an Elmiron lawsuit, a patient must have taken the drug for two years or more and been diagnosed with vision problems such as maculopathy. You should visit an ophthalmologist if you are experiencing any of the following symptoms:
- Blurred vision
- Difficulty reading
- Slow adjustment to low or reduced light conditions
- Changes in eye color pigment
- Vision loss
- Loss of night vision
- Trouble focusing
- Paracentral scotoma
Your doctor may perform a retinal examination with imaging tests as part of a comprehensive eye exam. In order to best assist you, our legal team will want to know your official diagnosis, so it is important to visit a doctor before contacting a lawyer.
Receive a Free Elmiron Lawsuit Consultation
The bladder pain and other symptoms of IC are difficult to live with. Elmiron may relieve your IC symptoms, but long term exposure to the drug could result in permanent vision loss. You were never warned about potential vision damage when you started taking Elmiron because until recently, the manufacturer never mentioned it. Now, you’ve been diagnosed with a serious eye condition and want to know how to take legal action.
Milberg is here to help. Our law firm built its reputation by fighting for victims of some of the world’s most powerful corporations. Milberg’s defective drug attorneys are national leaders in mass tort and class action litigation. We have the resources, the experience, and the strength to hold Big Pharma accountable. Since 1965, Milberg has prosecuted landmark cases that have set groundbreaking legal precedents, prompted meaningful changes in corporate conduct, and recovered over $50 billion for injured consumers.
Milberg handles Elmiron lawsuits on a contingency-fee basis. Our clients pay no legal fees unless and until we recover compensation for you. If you were diagnosed with vision problems after taking Elmiron, contact us for a free case review.