Elmiron Lawsuit | The Guardian Legal Network

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Elmiron

Recent studies show that when people used the medication Elmiron long-term, they experienced maculopathy, an eye disorder that can cause permanent blindness. Several patients who took Elmiron developed pigmentary maculopathy, according to doctors who have studied the drug. A study from The American Academy of Ophthalmology reported that patients were recommended to have their eyes examined while still on the medication to see if they have maculopathy. If they did, they needed to stop taking it right away. Patients are suing Janssen Pharmaceuticals, the drug manufacturer because the company failed to warn them about the possible dangers associated with the drug.

Patients who have taken Elmiron and suffered severe side effects will need an experienced dangerous drugs lawyer to help them with their case. The Guardian Legal Network can connect Elmiron victims with experienced law firms.

What is Elmiron?

Also known as pentosan polysulfate sodium, Elmiron is used as a bladder protectant and a blood thinner to treat pain and bladder discomfort caused by inflammation or irritation (cystitis). Elmiron is currently the only medication on the market that can treat bladder pain and discomfort resulting from interstitial cystitis, which is part of a series of diseases known as painful bladder syndrome or bladder pain syndrome. Over time, if the problem is left untreated, bladder pressure, as well as bladder and pelvic pain, can become moderate to severe. Women are affected by the disorder more than men, as it gives them the sensation that they need to use the restroom more often.

Elmiron is one of the only medications approved by the FDA to treat interstitial cystitis or bladder pain syndrome.

Elmiron Linked to Maculopathy

Studies have shown that Elmiron causes retinal maculopathy, a severe eye disorder. Long-term use of Elmiron can increase the risk of someone developing this disease. Maculopathy, also known as macular degeneration, is a disease that damages the central part of a person’s retina, the macula. Maculopathy causes a person’s central vision to rapidly decline and eventually leads to vision impairment. Pigmentary maculopathy of unknown etiology (injury to a person’s macula with no known cause) is the type of macular degeneration linked to Elmiron usage.

Symptoms related to retinal maculopathy include:

Blurred or distorted vision
Difficulty reading
Eye pain
Loss of central vision
Loss of clear color vision
Permanent loss of sight
Straight lines appear wavy or crooked
Vision changes in low light
Vision irregularities

Evidence Linking Elmiron to Severe Eye Damage

Elmiron was once viewed as a safe drug to use with few serious side effects. Since Elmiron’s initial release in 1996, this view has changed drastically.

Elmiron’s toxicity was discovered in 2018 when physicians from Atlanta, Georgia-based Emory Eye Center noticed an odd trend. Six patients were diagnosed with pigmentary maculopathy. Eventually, doctors were able to link Elmiron to these cases, which led the eye center to publish a preliminary study that suggested Elmiron could potentially damage the retinal tissue in a human’s eye.

The warning called for a more thorough investigation into Elmiron’s safety, as well as its toxicity to the eyes. Another study was conducted by a large group of ophthalmologists in Northern California, based on several thousand patient records. In October 2019, the study’s alarming results were presented at The American Academy of Ophthalmology’s annual meeting.

The research results showed that Elmiron was toxic to the retinal tissue found in the back of the human eye. Signs of significant eye damage, or maculopathy, were displayed in 25% of Elmiron patients. A majority of these victims experienced a partial loss of vision or lost their vision entirely. Doctors found signs of drug toxicity related to the long-term use of the medication when these patients were tested and examined.

Elmiron Patients at Risk

Elmiron was released into the market as one of the only approved medications that could treat interstitial cystitis (IC), which affects millions of Americans, especially women.

Thousands of patients who took the drug increased their risk of developing permanent damage to their sight while they were still on it. Patients who were prescribed Elmiron for interstitial cystitis or urinary tract infections (UTIs) are at a heightened risk of developing maculopathy.

Providers may not even know that Elmiron was the cause of their patient’s vision problems, as studies linking it to retina or macula-related vision issues are relatively new.

Patients Are Filing Elmiron Lawsuits

Most Elmiron lawsuits have claimed that the drug can cause maculopathy and various other eye conditions if patients are exposed to the medication long-term. Victims have alleged that the pharmaceutical company did not warn patients or physicians about the possible risks associated with the drug. While Janssen Pharmaceuticals did list a few side effects a patient could experience while they were on the drug, the packaging failed to provide warnings regarding maculopathy until June 2020. Janssen either knew or should have been aware that Elmiron could cause maculopathy but did not include these warnings on the medication label.

The medication label did not mention any warnings related to pigmentary maculopathy or any other type of maculopathy. The only place patients could find any vision or ocular-related issues regarding nystagmus, conjunctivitis, optic neuritis, amblyopia, or retinal hemorrhage was in the Adverse Reactions section. The label did not include any relevant warnings, and no mention was made in a post-marketing setting about the negative side effects of Elmiron.

Patients who were on the medication prior to the warning label changes are currently filing claims against the drug manufacturer, and Elmiron lawyers are actively investigating the case for victims. Individuals must meet the following criteria in order to file an Elmiron lawsuit:

The plaintiff took Elmiron for at least six months or longer; AND
They experienced vision issues after using the medication and were diagnosed with the following:
- Retinal dystrophy
- Macular retinopathy or maculopathy
- Age-related macular degeneration
- Other conditions related to the retinal portion of the eye

Injured victims who meet the above criteria should contact an Elmiron lawyer as soon as possible to learn more about taking legal action. You could receive financial compensation for any physical, emotional, and financial damages you have suffered due to the pharmaceutical company’s negligence. Your Elmiron lawyer will conduct extensive research, collect evidence and medical documents, and fight for the maximum settlement amount.

Elmiron Case Updates

June 2020 Case Update: Janssen Pharmaceuticals changed Elmiron’s prescription labels due to thousands of lawsuits. The United States did not have any risks listed previously under the “Warnings” section. The label now includes, “Pigment changes to an eye’s retina, referred to as pigmentary maculopathy, were reported in people who used ELMIRON long-term.” The FDA approved the new label change on June 16, 2020.

November 2020 Case Update: Elmiron lawsuits filed in federal courts are planned to be consolidated into one large multidistrict litigation (MDL) in December. A motion was filed to request the consolidation and transfer of the lawsuits to an MDL with the Judicial Panel on Multidistrict Litigation (JPML). The motion was unopposed, and a decision was scheduled to be made by the JPML on December 3rd. The venue for the Elmiron MDL was presumed to be in the District of Pennsylvania or New Jersey.

December 2020 Case Update: In the District of New Jersey, all federally filed Elmiron cases were ordered by the U.S. Judicial Panel on Multidistrict Litigation to be consolidated as MDL 2973. Judge Brian R. Martinotti has been appointed to oversee the proceedings. After all of the arguments were considered, the panel noted that centralizing these actions would serve the convenience of the witnesses and parties in the District of New Jersey and promote the efficient, just conduct of the lawsuits.

Find an Elmiron Lawyer with The Guardian Legal Network

If you believe your vision was impaired or lost while taking Elmiron, contact The Guardian Legal Network. We can help you find an experienced drug injury lawyer who will fight to get you the compensation you deserve.

References

Hanno PM. “Analysis of long-term Elmiron therapy for interstitial cystitis”, US National Library of Medicine National Institutes of Health, https://www.ncbi.nlm.nih.gov/pubmed/9146008. Accessed January 18, 2021.
Jenelle Foote, Adam Hanif, Nieraj Jain. “Chronic Exposure to Pentosan Polysulfate Sodium Is Associated With Retinal Pigmentary Changes and Vision Loss”, The Journal of Urology, https://www.auajournals.org/doi/pdf/10.1097/01.JU.0000556315.46806.ca. Accessed January 18, 2021.
Pearce WA, Chen R, Jain N. “Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium”, US National Library of Medicine National Institutes of Health, https://www.ncbi.nlm.nih.gov/pubmed/29801663. Accessed January 18, 2021.
RxList. “Elmiron”, RxList, https://www.rxlist.com/elmiron-side-effects-drug-center.htm. Accessed January 18, 2021.
WebMD. “Elmiron”, WebMD, https://www.webmd.com/drugs/2/drug-14085/elmiron-oral/details. Accessed January 18, 2021.

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