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Elmiron Vision Loss & Severe Eye Disorders

Written by Joseph Lyon on . Posted in Pharmaceutical Litigation.

Cincinnati, Ohio Defective Drug Attorney and Toxic Exposure Lawyer reviewing Elmiron vision loss cases on behalf of plaintiffs nationwide

UPDATE: Janssen Issues New Safety Warning for Patients Taking Elmiron

For at least five years, since 2015, some leading doctors and consumer safety experts have had concerns regarding the safety of Elmiron–investigating whether the drug may lead to pigmentary maculopathy, a condition that causes the loss of vision.

A report last year at the American Academy of Ophthalmology’s (AAO) suggested taking pentosan polysulfate sodium (Elmiron) can be toxic to the retina. The report concluded there are major concerns that patients taking Elmiron can suffer from serious and permanent vision problems and vision loss.

More than 1 million people in the United States have been diagnosed with interstitial cystitis, a painful bladder syndrome, and Elmiron is the only FDA-approved medication to treat the condition.

But Elmiron is now linked in studies to causing severe eye disorders that can lead to blindness in some patients. According to the Food and Drug Administration (FDA), there have been at least 100 reported cases of Elmiron patients suffering eye disorders, including forms of maculopathy. Common symptoms of maculopathy may include:

  • Difficulty reading
  • Blurred or distorted vision
  • Chronic eye pain
  • Vision disturbances
  • Vision loss & Blindness
  • Difficulty adjusting to darkness

Joe Lyon is a Cincinnati, Ohio Product Liability Lawyer investigating drug injury cases and toxic pharmaceutical lawsuits on behalf of plaintiffs nationwide.

Elmiron Vision Loss Lawsuits

Researchers have found that up to 25 percent of long-term Elmiron patients may show evidence of retinal damage. The toxicity of a defective medication could also appear to mimic other retinal conditions.

Plaintiffs have filed vision loss lawsuits against Janssen Pharmaceuticals, the maker of Elmiron, following the development of maculopathy, a part of the retina that controls aspects of one’s vision. Damage to the macula can cause severe eye disorders and blindness. There are different kinds of maculopathy, including:

  • Age-Related Macular Degeneration – a gradual loss of vision that originates in the central field of vision and is related to natural aging.
  • Cellophane Maculopathy – a form of visual distortion that causes a thin, transparent layer of scar tissue over the light-receptor nerve cells in the macula.
  • Malattia Leventinese – also known as Doyne Honeycomb Retinal Dystrophy (DHRD), this condition produces pale spots in the macula that eventually grow.

Elmiron Safety Studies

In 2018, the American Academy of Ophthalmology published an article about six Elmiron patients who were diagnosed with pigmentary maculopathy. In the last couple years the number of patients complaining of eye problems has increased.

A researcher at the Emory Eye Center alerted the public that taking Elmiron is linked retinal injury. The researcher said that all patients in the study showed signs of retinal disease. One patient began showing visual symptoms by the age of 30.

The study showed several subjects had atypical changes in their retina. The patients noted difficulty reading in dim light as well as a diminished central visual acuity. This led researchers to issue a warning that long-term use of Elmiron could potentially lead to retinal damage.

What is Elmiron?

Elmiron (pentosan polysulfate sodium) is commonly prescribed to treat interstital cystitis, a bladder disorder. Elmiron attaches itself to the bladder wall and provided a buffer to irritating substances, decreasing debilitating pain.

Elmiron is currently the only FDA-approved drug to treat interstitial cystitis. It was first approved for use in humans by the US Food and Drug Administration (FDA) in 1995. Janssen Pharmaceuticals, a division of Johnson & Johnson, has not issued an Elmiron recall, nor have they offered to conduct further clinical studies to provide patients with clear drug safety information. Studies of thousands of patients taking Elmiron for up to four years have shown sign of the following:

  • Optic neuritis
  • Amblyopia
  • Retinal hemorrhage

Has Elmiron Been Recalled?

Elmiron has faced no recalls, but Janssen has alerted consumers to a possible health risk of taking the medication. A new warning alerts doctors and patients to look for changes in the retina of the eye, which could indicate potential damage to the patient’s vision.

Not until June 2020 did the company finally add a new warning about eye disease to the Elmiron label. The new safety warning notes that pigmentary changes in the retina have been identified with patients’ long-term use of Elmiron, and says that some cases had also occurred with short-term use.

The long-term effects of Elmiron are still being studied. Patients currently prescribed the medication should contact their physician and discuss potential health hazards and possible alternative treatments.

How is the bladder medication causing vision loss? Though this drug has been on the market for nearly 25 years, it was not until recently that doctors and patients began questioning the safety of the drug.

Elmiron has not been recalled, though some patients may choose to discontinue treatment with the advice of their prescribing doctor. Further clinical testing may be needed to fully understand the effects of the pharmaceutical on the body.

Some experts recommend that patients who show no retinal signs of toxicity be screened for retinal damage at least once a year. Patients who do show signs of vision loss should speak with their health care provider, and contact a drug injury attorney.

Pharmaceutical Injury Attorney

Lawsuits filed against Johnson & Johnson Pharmaceuticals and Janssen Pharmaceuticals have alleged that the “dangerously defective prescription drug was designed, marketed, and distributed…while knowing significant risks that were never disclosed to the medical and healthcare community.”

You may choose to contact an experienced lawyer following any drug injury. The Lyon Firm has experience engaging large drug companies when their products cause injuries and serious side effects. When drug companies fail to warn consumers and fail to properly test their medications, they may be held liable in product liability lawsuits.

If you or a loved one has suffered any vision loss or retinal damage due to the use of Elmiron or another medication, you can call The Lyon Firm for a free consultation at 800-513-2403. Legal recourse may be the only way to compensate injured consumers, and can hold companies accountable for unsafe pharmaceuticals and defective drugs.

Amblyopia, Eye Injury, Interstitial Cystitis, Optic Neuritis, Retinal Injury, Toxic Medication, Vision Loss

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