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Elmiron Vision Loss


Elmiron (pentosan polysulfate sodium), a drug widely prescribed for a bladder condition, has been associated with eye damage. Hundreds of thousands of people who have taken Elmiron may have been exposed to the risk of potentially permanent vision damage. Recent studies suggest that Elmiron is toxic to the retina, and one study shows that about 25 percent of patients with significant exposure to the drug show signs of retinal damage. As a result of these studies, vision loss lawsuits have been filed against Janssen Pharmaceuticals for failing to properly warn the public about the risk of vision problems.

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Research Links Elmiron to Retinal Damage

Eye hemorrhage thumb 2Research presented in October 2019 to the American Academy of Ophthalmology has linked Elmiron to retinal damage. Researchers concluded that Elmiron “appears to be toxic to the retina”, which is a thin layer of tissue at the back of the eye that receives light and allows us to see.  The study, which was conducted by three ophthalmologists at Kaiser Permanente in Northern California, reviewed 140 patients who had taken an average of 5,000 pills each over the course of 15 years. They found that the rate of toxicity rose with the amount of drug consumed.

About a year before this study, Dr. Nieraj Jain at the Emory Eye Center in Atlanta, GA., had raised a red flag about Elmiron. He reported that six patients who had been taking the drug for about 15 years had developed unusual changes in a part of the retina called the macula, which is responsible for delivering clear, crisp, central vision. Those researchers issued a warning in 2018 that long-term use of Elmiron could potentially lead to retinal damage.

What is Elmiron?

Elmiron was approved in 1996 by the FDA as a treatment for the relief of pain and discomfort associated with interstitial cystitis (IC), a chronic, progressive and debilitating urinary bladder disease afflicting primarily women. IC, also known as “painful bladder syndrome”, is characterized by severe bladder and pelvic pain and urinary frequency. It is the only FDA-approved pill to treat it IC.  Health Canada updated its information on Elmiron in 2019, advising patients to get regular eye exams and to discontinue the drug if vision problems develop.

Elmiron Side Effects

On Elmiron’s website, Janssen Pharmaeuticals, the drug’s manufacturer, has not included permanent vision loss in its list of side effects. However, it does list the following visual side effects in the less than 1 percent category:
  • Conjunctivitis
  • Optic neuritis
  • Amblyopia
  • Retinal hemorrhage
Dr. Vora, one of the ophthalmologists at Kaiser Permanente and one of the study’s co-authors, said Elmiron eye problems fall into a wide range -- from just blurry vision, to difficulty reading, to having difficulty adjusting and seeing in different lighting conditions. The most common visual symptoms reported in studies were difficulty reading and difficulty adapting to dim lighting.

Patients who show no signs of toxicity should be screened for retina damage at least once a year, advises Dr. Vora. For those who do show some signs of damage, he suggests they speak with their urologist or ob/gyn about Elmiron. If damage is identified early on, symptoms may lessen by stopping the medication. In the late-stage, toxicity can result in permanent vision loss.  Eye damage allegedly caused by Elmiron is similar to other retinal conditions, such as age-related macular degeneration or pattern dystrophy.

Other side effects and potential diagnoses may include:
  • Pigmentary Maculopathy
  • Blurred Vision
  • Visual Distrubances
  • Retinal Maculopathy
  • Macular Degeneration
  • Pattern Dystrophy
  • Blindness (unilateral or bilateral)

Elmiron Lawsuits

Lawsuits claim long-term exposure to Elmiron causes maculopathy, an eye disorder affecting the macula (central part of the retina) and a major cause of blindness.

Plaintiff Tina Pisco filed an Elmiron lawsuit on May 4, 2020,  against Janssen Pharmaceuticals and Johnson & Johnson (Janssen is a subsidiary of J&J) claiming the medication caused her to develop maculopathy — a degenerative disease of the retina — in her eyes.  Pisco started taking Elmiron in 2012 to treat interstitial cystitis. Sometime in 2018 she noticed that her vision was rapidly deteriorating and by March 2019, she was diagnosed with permanent retinal injury in both eyes, according to her lawsuit.

Pisco claims 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.”  Since its FDA approval in 1996, Janssen has marketed Elmiron as a safe and effective treatment for both IC and osteoarthritis.  On its prescribing information, warnings are “none”, said Pisco’s attorney. Janssen lists the drug’s side effects and warnings but has no information about the risks of maculopathy, a type of disease that affects the macula.

Pisco alleges in her complaint that Janssen  “withheld material adverse events” and “failed to disclose the serious link between Elmiron use and significant visual damage, including pigmentary maculopathy.”
In March 2020, Kimberly Pelczar, a Connecticut Woman, filed an Elmiron lawsuit against Teva Pharmaceuticals USA and Janssen, alleging ‘Permanent Retinal Injury’.  In her lawsuit, Pelczar claims that she began taking Elmiron in 2005 and ten years later began to suffer eye problems. From 2015 to 2019, she saw medical providers for her visual symptoms. She was diagnosed with permanent retinal injury and vision loss because of Elmiron toxicity in 2019.

According to her lawsuit, drugmakers failed to properly warn physicians and the public that Elmiron could cause vision problems and that drug makers actively hid the side effects from the public.
 

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ELMIRON VISION LOSS LEGAL ARTICLES AND INTERVIEWS

Under Pressure, Elmiron Manufacturer Updates its Label
Under Pressure, Elmiron Manufacturer Updates its Label
July 17, 2020
Harrisburg, PA Only after pressure from scientists and consumers and mounting Elmiron vision loss lawsuits, Janssen Pharmaceuticals has finally updated its Elmiron interstitial cystitis drug label, adding the risk of developing permanent eye damage to its side effects. But a quick scan online shows that numerous health sites and pharmacies have not received the memo.
READ MORE

Elmiron Vision Loss Lawsuits Mounting
Elmiron Vision Loss Lawsuits Mounting
June 5, 2020
Santa Clara, CA On the heels of studies linking the bladder drug Elmiron to vision loss, lawsuits are being filed nationwide against Janssen Pharmaceuticals, claiming the interstitial cystitis medication causes serious vision damage, namely maculopathy — a degenerative disease of the retina. Further, the drug manufacturer has been accused of knowing the Elmiron vision risks and not disclosing them.
READ MORE

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