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Update: Elmiron Side Effects “Patient Zero” Files Lawsuit in New Jersey

A South Carolina woman who allegedly suffered permanent eye damage from Elmiron has filed a products liability lawsuit against Janssen Pharmaceuticals in the Superior Court of New Jersey, Middlesex County. Plaintiff Valarie Hull, whose case was documented as “Patient Zero” in a 2018 study by the Emory Eye Center in Atlanta, Georgia, claims she developed changes in eye color pigment, severe vision degradation, loss of night vision, and pigmentary maculopathy after taking Elmiron from 2001 to 2018.

Hull was subsequently treated by Dr. Nieraj Jain, an ophthalmologist at Emory Eye Center who later based a study on her case and those of 4 other patients with the same eye problems who all took Elmiron. The lawsuit accuses Janssen and several other Johnson & Johnson entities of failing to warn of the risk of severe vision-related injuries with Elmiron. The complaint is: Hull vs. Janssen Pharmaceuticals Inc., et al., Case No. MIDL003646-20.

What is Elmiron?

Elmiron (generic: pentosan polysulfate sodium) is used to treat pain/discomfort from a bladder disorder called interstitial cystitis, according to WebMD. The drug works to mitigate bladder irritation and discomfort by forming a layer on the bladder wall and protecting it from harmful/irritating substances in the urine. Elmiron is made by Janssen Pharmaceuticals, and was first approved to treat bladder pain by the U.S. Food & Drug Administration (FDA) in 1996.

New Eye Disease Found in Elmiron Bladder Patients

From 2015 to 2018, ophthalmologists at the Emory Eye Center in Atlanta, Georgia, identified an entirely new eye disease in 6 female patients who took Elmiron for bladder pain. The physicians made the discovery through the use of advanced retinal imaging, and classified the disease as “retinal maculopathy” or “retinal pigmentary endothelium injury” (RPE), meaning that the pigment cells inside the eye’s retina literally change color.

This change in color causes severe vision problems, similar to those experienced by patients with age-related macular degeneration. Retinal maculopathy is so similar in appearance to macular degeneration, in fact, that most patients with the condition would probably be incorrectly diagnosed, according to Emory doctors. Their findings were published in the May 2018 edition of the Journal of Ophthalmology.

Retinal Maculopathy Symptoms

  • Visual distortions, such as straight lines seeming bent
  • Reduced central vision in one or both eyes
  • The need for brighter light when reading or doing close work
  • Increased difficulty adapting to low light levels, such as when entering a dimly lit restaurant
  • Increased blurriness of printed words
  • Decreased intensity or brightness of colors
  • Difficulty recognizing faces

Source: ScienceDirect

Follow-Up Study Finds Eye Damage in 24% of Elmiron Patients

Shortly after the Journal of Ophthalmology study on retinal maculopathy was published, physicians at Kaiser Oakland began searching their database for patients who took Elmiron for interstitial cystitis or bladder pain. They found at least 140 patients who had been taking the drug for at least 5 years. Of these, 91 agreed to undergo an eye exam. The researchers found that 22 of the 91 Elmiron patients who took the exam presented symptoms of the exact same eye disease as the one identified by Emory doctors in Atlanta.

Maculopathy Treatment

There are a number of potentially effective treatments for retinal maculopathy, including:

  • Intravitreal injection of medications able to stop neovascular growth (anti-VEGF drugs)
  • Photodynamic therapy
  • Laser photocoagulation
  • Surgery (telescopic lenses implant, IolAMD)

Source: Community Eye Health Journal

IC Network Finds 54% of Elmiron Users With Retinal Disease

The Interstitial Cystitis Network, one of the largest advocacy groups for people with interstitial cystitis, recently conducted a survey of its members who took Elmiron for bladder pain. Results suggested that of the 1,064 Elmiron users in the network, 53.87% had symptoms of retinal disease. IC Network sent their findings to the FDA with a petition seeking changes to the Elmiron Warning Label (PDF), recommending that interstitial cystitis patients who take Elmiron should be examined at least once per year to look for symptoms of retinal maculopathy.

Harvard Ophthalmologist Warns Vision Loss May Continue After Quitting Elmiron

Dr. Rachel M. Huckfeldt, an eye doctor at Harvard Medical School who specializes in retinal degeneration, recently published a case report in the journal Ophthalmic Surgery Lasers and Imaging Retina about a female patient she treated for more than 8 years. The patient initially came to Dr. Huckfeldt with symptoms of age-related macular degeneration (blurry vision, difficulty seeing at night / in dark environments). There was no family history of eye disease and DNA testing determined that her condition was not genetic.

Six years later, the patient returned to Dr. Huckfeldt complaining that her symptoms had worsened. With no clear explanation as to what was causing the problem, Huckfeldt was left to assume the patient was suffering from “toxic retinopathy,” meaning she must have been exposed to a toxin that was damaging her eyes.

It wasn’t until May 2018 — the same month the Journal of Ophthalmology study was published — that Dr. Huckfeldt finally made the connection between her patient’s eye damage and Elmiron. As it turns out, the patient had taken a prescribed 200 mg daily dose of Elmiron, but had discontinued treatment with the drug on her own more than 6 years earlier. This means the patient’s eye problems continued to worsen even after quitting Elmiron.

Elmiron Side Effects

In addition to potentially increasing the risk of severe eye damage, Elmiron has been linked to the following serious side effects:

  • Unusual bruising or bleeding (e.g., blood in stool)
  • Mental/mood changes
  • Heartburn
  • Discomfort when swallowing

Common side effects of Elmiron include:

  • Diarrhea
  • Hair loss
  • Nausea
  • Headache
  • Stomach upset or pain
  • Abdominal pain
  • Dizziness
  • Depressed mood
  • Itching or skin rash

Source: RxList

Can I Participate in a Class Action?

At this time, the law offices of Schmidt & Clark, LLP, are only reviewing potential individual lawsuits, instead of a class action, for people who developed eye damage from Elmiron. Our lawyers feel that individual suits are the best way to ensure maximum payouts for our clients. If you’ve been injured by Elmiron, contact us now to learn more about your rights.

Do I Have an Elmiron Lawsuit?

The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Elmiron Lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.

If you or a loved one suffered any type of eye damage from Elmiron, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.

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To contact us for a free review of your potential case, please fill out the form below or call us toll free 24 hrs/day by dialing: (866) 223-3784.

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