Elmiron Lawsuit – Patients are prescribed Janssen Pharmaceuticals’ Elmiron (pentosan polysulfate sodium) to treat bladder conditions. But mounting evidence links long-term Elmiron use to serious side effects in a different part of the body—the eyes.
Elmiron lawsuits claim that Janssen failed to warn the drug can cause serious vision problems, including an eye disorder called maculopathy. Elmiron has been available by prescription for decades, but the label for Elmiron did contain information about eye disease until June 2020. Before then, many thousands of patients were prescribed Elmiron, completely unaware that the medication could be damaging their vision.
You may have a case against Janssen if you are took Elmiron and were diagnosed with eye problems related to the macula or retina, such as macular degeneration or pigmentary maculopathy. The lawyers at Sanders Phillips Grossman are investigating Elmiron vision problems and offering free consultations. Contact Us to speak with an attorney.
Elmiron Uses and Approval History
Elmiron is a mild blood thinner drug prescribed to patients with interstitial cystitis (IC), a chronic inflammatory condition of the bladder that causes pressure, pain, and frequent urination. IC affects an estimated one million U.S. patients, most of them women.
Janssen Pharmaceuticals markets Elmiron as the “only oral medication FDA approved to treat the bladder pain or discomfort of interstitial cystitis.” The FDA approved the drug for “compassionate use” in 1986 and granted regulatory approval to it in 1996. Elmiron has been prescribed by urologists and gynecologists to hundreds of thousands of patients suffering from IC. Annual sales of Elmiron exceed $150 million annually, despite the drug’s limited efficacy. From 1997 to 2020, hundreds of reports for eye disorders were filed with the FDA’s adverse event reporting system. More than 80% of the reports were categorized as “serious.”
Doctors Warn of Elmiron and Eye Disease
The association of Elmiron with serious eye problems was first reported in 2018 by a group of ophthalmologists from Emory Eye Center. The doctors found pigmentary maculopathy in six patients with chronic exposure to pentosan polysulfate sodium (PPS) and reported their findings in the journal Ophthalmology. They were so concerned that they also wrote a letter to the editor of the Journal or Urology.
“We wish to alert readers to a concerning new observation of vision threatening retinal changes associated with long-term exposure to PPS,” the doctors said in the letter. “Examination findings of patients with this condition are suggestive of injury to the retina and the underlying retinal pigment epithelium. After extensive investigations, which included molecular testing for hereditary retinal disease, we found these cases to resemble no other retinal disease.”
Since this initial report, more than a dozen papers have been published in the medical literature regarding Elmiron and vision problems.
- About a year after the team from the Emory Eye Centerpublished their initial findings, they submitted an expanded study of ten interstitial cystitis patients who had taken Elmiron and experienced macular disease. They concluded that the patients were experiencing structural changes of the retina.
- Following up on the research done by the doctors at Emory, ophthalmologists at Kaiser Permanente reviewed Kaiser’s entire database of 4+ million patients. They identified 140 patients who had taken approximately 5,000 Elmiron pills over a period of 15 years. Of these, 91 agreed to be examined; 22 of the 91 showed signs of drug toxicity. Patients who took more of the drug displayed greater toxicity.
- Doctors published a case report in Ophthalmic Surgery, Lasers and Imaging Retina of a patient whose Elmiron-associated maculopathy continued to progress for six years after discontinuing the medication.
- In November 2019, a study published in the British Journal of Ophthalmology compared Elmiron users at 5 years and 7 years and found that, at 7 years, Elmiron users had significantly increased odds of macular disease.
- Robin A. Vora, Amar P. Patel, and Ronald Melles of Kaiser Permanente examined data for 117 IC patients who took Elmiron and found 27 with definite signs of maculopathy.
Writing in Retina Today in March 2020, a group of doctors reviewed the current body of research and wrote that, “Mounting evidence links chronic exposure to pentosane polysulfate sodium with the development of a novel pigmentary maculopathy.” They warned that these findings “represent a major patient safety issue” and noted many patients with PPS exposure may have been misdiagnosed with age-related eye problems, which “may have led to preventable, irreversible vision loss.”
Are you suffering from vision problems after taking Elmiron? Receive a free case review.
Who Qualifies For An Elmiron Lawsuit?
To be considered a lawsuit candidate, an Elmiron patient must have taken the drug for two years or more and suffered vision problems. Plaintiffs filing Elmiron lawsuits have typically alleged that they were diagnosed with maculopathy and resulting visual injuries. Symptoms that you might be experiencing Elmiron-related maculopathy include:
- Blurred vision
- Vision loss
- Loss of night vision
- Slow adjustment to low or reduced light conditions
- Trouble focusing
- Difficulty reading
- Changes in eye color pigment
- Metamorphopsia (linear objects appear curved or rounded)
- Paracentral scotoma (blind spot that appears in the center of the field of vision)
If you are a long-term Elmiron user experiencing any of these symptoms, you should get examined by an eye doctor. Eye imaging exams may be needed for an accurate diagnosis. Doctors have reported that signs of Elmiron-induced maculopathy include abnormal blood vessels around the macula and hyperpigmented or dark spots near the retina. When speaking to our lawyers, they will want to know your official diagnosis, so it is important that you get your vision problems checked out right away.
Janssen Updates Elmiron Warning Labels in 2020
The Food and Drug Administration (FDA) approved changes to Elmiron’s safety labeling in June 2020—nearly 24 years after the drug was initially approved in September 1996.
According to the new label, Elmiron can cause pigmentary changes in the retina accompanied by visual symptoms. Patients are cautioned to undergo ophthalmologic examination prior to starting Elmiron and periodically during long-term treatment.
Prior to this label change, Janssen only described conjunctivitis, optic neuritis, amblyopia, and retinal hemorrhage as visual side effects of Elmiron, and these side effects fell in the “less than 1%” category. More troubling, Janssen changed Elmiron’s warning label in Canada to warn of eye injuries a year earlier than they did in the United States.
Women Filing Elmiron Lawsuits
The updated safety label changes for U.S. users only came after Elmiron lawsuits were filed. The lawsuits similarly claim that the plaintiffs developed visual injuries from taking Elmiron, and that Janssen Pharmaceuticals did not warn about possible visual side effects of the drug.
- A Connecticut woman filed an Elmiron lawsuit in March 2020. The plaintiff says that she started taking Elmiron in 2005 and in 2019, she was diagnosed with permanent retinal injury and vision loss that she blames on Elmiron toxicity.
- A plaintiff filed a complaint in May 2020 claiming that she was diagnosed with permanent retinal injury in both eyes as a result to taking Elmiron for six years. Her complaint accuses Janssen Pharmaceuticals of designing, marketing, and distributing a defective drug.
- A South Carolina woman who was the subject of Emory Eye Center research sued Janssen Pharmaceuticals in June 2020 for allegedly failing to warn about Elmiron vision injuries. She allegedly used Elmiron from 2001 – 2018 and has been diagnosed with pigmentary maculopathy.
Free Elmiron Lawsuit Case Review
Visual impairment is one of the most dreaded injuries that a person can experience. What’s worse, evidence strongly suggests that Elmiron vision loss was preventable.
If you were diagnosed with vision loss, pigmentary maculopathy, or eye disease and took Elmiron for more than two years, you may be eligible for a lawsuit against Janssen. A personal injury lawsuit can provide compensation for medical expenses, lost wages, pain and suffering, loss of enjoyment of life, and other losses.