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Elmiron medication is the only oral medication on the market approved by the FDA to treat painful bladder syndrome. Elmiron (pentosan polysulfate sodium) was first approved in 1996 for the treatment of interstitial cystitis, more commonly known as painful bladder syndrome.

However, the blockbuster drug has been found to cause severe side effects in patients. In late 2019, research found Elmiron increases patients’ risk of developing eye damage and vision loss. Elmiron eye damage has been found to even cause blindness in some patients.

Individuals who took Elmiron for their bladder condition may be at an increased risk of developing serious eye damage from toxic medication. If you took Elmiron, you may be entitled to compensation for your eye and vision injuries. Reach out to us today and get your free case consultation.


Pentosan polysulfate sodium, branded as Elmiron, is a medication used to treat a painful bladder condition known as interstitial cystitis. Interstitial cystitis, otherwise known as painful bladder syndrome, is a chronic condition with no known cure. Typically, those diagnosed often have to stay on treatment for years, sometimes decades.

Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, introduced Elmiron to the market in 1996 to treat painful bladder syndrome. Elmiron can also be used as an anticoagulant and to treat osteoarthritis. However, in the last few years health officials linked the medication to causing vision injury and a serious eye condition that can lead to blindness.

Researchers found Elmiron caused patients to experience eye damage called pigmentary maculopathy. This is a condition that affects the center part of the retina, such as causing dark spots or lesions. The retina is linked to one of the most crucial parts of vision, so damage to this area of the eye can cause severe eye disorders and blindness. Side effects of pigmentary maculopathy may include dark spots on the eye, vision loss, blurry vision, and prolonged adaptation to dim light.

An October 2019 study found that out of 91 patients taking large amounts of Elmiron over the years, 22 of them showed obvious signs of retinal toxicity; this toxicity amount rose with the amount of Elmiron taken. Overall, 25% of the patients who took large quantities of Elmiron over the years had obvious symptoms of maculopathy.

If you have taken Elmiron and are showing signs of eye damage, speak to your doctor immediately about discontinuing your medication or finding a replacement.

Symptoms of toxic Elmiron may include:

  • Dark spots on the retina that are hyperpigmented
  • Vision loss from parafoveal pigmented deposits
  • Yellow lesions under the macula called vitelliform deposits
  • Retinal pigment epithelium atrophy

New Elmiron Warning Label

On June 16, 2020, the FDA issued a new warning label about Elmiron increasing user’s risk of developing pigmentary maculopathy and other vision injuries. This warning label came several months after Canada issued their own updated Elmiron warning.

“Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use,” the warning shows. “While the etiology is unclear, cumulative dose appears to be a risk factor.”

Additionally, Elmiron’s new warning label recommends for doctors to use extreme caution in diagnosing patients with previous retinal pigmentary changes. The FDA recommends for healthcare professionals to get a detailed ophthalmologic history before starting patients on Elmiron treatment.

Through the Food and Drug Administration Adverse Reporting System (FAERS), the FDA states there were 100 cases of Elmiron patients diagnosed with eye disorders between 1997 and 2019. Despite the evidence presented by researchers, an Elmiron recall has not been issued by the FDA as of yet.

Elmiron Eye Damage Lawsuits

If you took Elmiron for your bladder condition and were diagnosed with eye damage, you may be a victim of toxic Elmiron medication. Experts anticipate thousands of Elmiron eye damage lawsuits will be filed in the upcoming months and years against Janssen Pharmaceuticals as individuals find their vision loss was caused by toxic medication.

Elmiron’s manufacturers list many of side effects from taking the drug, including headaches, skin rash, sleep disorders, etc. However, eye damage has never been listed on the product’s packaging as a side effect until this year.

Because it took Jansseen Pharmaceuticals so long to inform users about the eye damage risks of Elmiron, individuals allege Janssen was negligent in their responsibility to consumers to inform them about the dangers of taking Elmiron.

We Can Help Protect Your Rights

If you developed eye damage after taking Elmiron, you may be entitled to compensation from the medication’s manufacturers. Janssen Pharmaceuticals, creators of Elmiron, withheld information about the dangerous side effects of their product and failed to warn the public about the risk of Elmiron eye damage. Their negligence should not mean you have to suffer needlessly without means for recovery.

After being injured by a company’s negligence, your rights deserve protecting. You have options for justice, and our personal injury lawyers are here to fight for your right to healing and recovery.

Making sure you have an experienced attorney on your side when filing a product liability claim is crucial.  At AVA Law Group, our personal injury lawyers have years of product liability experience under their belts and work tirelessly to make sure you get the compensation you deserve to help you recover from your injuries.

To speak with a trusted representative about your Elmiron case, reach out to us today at 1.800.777.4141. We offer free, no-obligation case evaluations around the clock for your convenience.

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