Elmiron Lawsuit

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Case Update 2020: Janssen Pharmaceutical Companies has changed their labels for Elmiron in the face of increasing lawsuits. Under the “Warnings” section, the United States had no risks previously listed. The new warning now includes “ Pigment changes in the retina of the eye (also referred to as pigmentary maculopathy in medical journal articles) have been reported with long-term use of ELMIRON”. The label change was recently approved by the FDA on June 16 , 2020.


According to recent studies, using the drug Elmiron long-term has caused maculopathy, which is a disorder of the eye that can lead to blindness. Doctors who have studied Elmiron said that they had identified several patients who had developed pigmentary maculopathy after taking the medication. A report from The American Academy of Ophthalmology said that doctors who have studied the drug strongly recommend that their patients undergo eye imaging while they’re on Elmiron to see if maculopathy is present. If it is, they should stop taking the drug immediately. Patients who took Elmiron are suing the drug manufacturer, Janssen Pharmaceuticals. Patients accuse the company of not warning them about the potential dangers associated with the medication, including the risk of blindness and maculopathy.

Any patient who took Elmiron and suffered dangerous side effects will need a drug injury law firm to assist them with their case. Broughton Partners can connect law firms to Elmiron injury victims. We are a legal marketing firm that assists attorneys by helping them find qualified Elmiron plaintiffs. We deliver qualified retainers with all the files a law firm needs to work on the case. Law firms can work alongside Broughton Partners to find qualified Elmiron plaintiffs that fit the necessary case criteria.

What is Elmiron?

Elmiron, also known as pentosan polysulfate sodium, is used as a blood thinner and as a bladder protectant to treat bladder discomfort and pain that’s caused by cystitis – an irritation or inflammation of the bladder. The drug is the only one currently on the market that’s used to treat bladder discomfort and pain related to interstitial cystitis, which is part of a family of diseases known as bladder pain syndrome, or painful bladder syndrome. If interstitial cystitis is left untreated, pelvic and bladder pain, as well as bladder pressure, can become moderate to severe over time. Women are mostly affected by this disorder. It can give them the sensation of having to use the restroom more frequently.

Elmiron is the only medication that’s approved by the FDA to treat bladder pain syndrome or interstitial cystitis. The patent on the drug has since expired as of 2010, which means that most patients are paying thousands of dollars out of their own pockets to obtain the medication since there aren’t any substitute drugs available.

The current marketer and manufacturer of Elmiron, Janssen Pharmaceuticals, which is a division of Johnson & Johnson, declined to explain why prices for the medication have skyrocketed, but the company is making significant profits off of it as the market for treatments associated with interstitial cystitis grows at an exponential rate.

Elmiron Linked to Risk of Blindness

It has been found that long-term exposure to Elmiron may cause maculopathy, which is an eye disorder that affects the central part of the retina (macula).

Elmiron Side Effects

The following side effects of Elmiron that are most common include:

  • Changes in a person’s mental state
  • Bruising
  • Bleeding (Elmiron can be used as a blood thinner)
  • Hair loss
  • Headaches
  • Abdominal pain
  • Diarrhea
  • Nausea

Elmiron & Maculopathy

One of the most serious complications from taking Elmiron is retinal maculopathy. Otherwise known as macular degeneration, maculopathy is a disease that’s related to the central part of the retina in a person’s eye – the macula.

Maculopathy, by definition, is the rapid loss of a person’s central vision, which is typically bilateral and causes vision impairment. The type of macular degeneration linked to Elmiron is specifically known as “pigmentary maculopathy of unknown etiology.” It is an injury to the macula with an unknown cause.

Symptoms associated with retinal maculopathy include:

  • Permanent loss of sight
  • Vision irregularities
  • Vision changes in low light
  • Eye pain

Who is at Risk?

The drug first came onto the market in the late 1990s as the only approved medication that could treat pain linked to interstitial cystitis (IC). This condition affects millions of Americans and is most prevalent in women.

Thousands of people who took this medication may have increased their risk of permanent vision damage while they were on it. Any patient who was prescribed Elmiron for urinary tract infections (UTI) or interstitial cystitis are at an increased risk.

Patients who took Elmiron and were diagnosed with vision problems as a result of taking it, their provider may not have known that Elmiron caused it. The studies that link the medication to macula or retina-related vision issues are relatively new.

Elmiron Lawsuit

Most lawsuits related to Elmiron have claimed that long-term exposure to the drug can cause a variety of eye conditions including maculopathy. Claimants allege that Janssen Pharmaceuticals didn’t warn doctors or patients about the possible dangers associated with the medication. Janssen listed a few side effects a patient may experience while taking the drug, however, the packaging did not include warnings related to maculopathy until June 2020. Plaintiffs believe that Janssen either knew or should have known, that this medication could cause maculopathy and didn’t mention these warnings on the medication label or in the literature.

The product label did not include any warnings regarding any type of maculopathy including pigmentary maculopathy. Patients have to look at the Adverse Reactions section to find any type of ocular or vision-related issues regarding retinal hemorrhage, amblyopia, optic neuritis, conjunctivitis, and nystagmus. There are no relevant warnings on the label and it makes no mention of any observed adverse effects in a post-marketing setting.

Patients who have taken Elmiron before the warning label changes were made are filing claims against the manufacturer.

 

May 2018

Physicians at Emory Eye Center conducted a case study of 6 adult patients who had taken pentosan polysulfate sodium for interstitial cystitis. They discovered that long-term use of the drug caused pigmentary maculopathy (an injury to a patient’s retinal pigment epithelium, which is a layer of cells that keeps the retina nourished).

April 2019

A second study published in the Journal of Urology was conducted by physicians at Emory Eye Center with 10 patients. Researchers discovered that patients who had a history of interstitial cystitis who didn’t take pentosan polysulfate sodium didn’t experience unique pigmented maculopathy compared with those who did take the medication. They asked patients who experienced any damage to their eyes to stop taking Elmiron immediately, and patients who didn’t experience any symptoms to have an ophthalmic examination and retinal imaging.

October 2019

A study was conducted by researchers at Kaiser Permanente with 140 patients who took 5,000 pentosan polysulfate sodium pills for 15 years. 91 of these patients agreed to an examination, and 22 of them experienced toxicity. Eleven percent of patients who took between 500 to 1,000 grams and 42 percent who took over 1,500 grams experienced increased toxicity.

November 2019

A cohort study showed that the patients who were taking pentosan had an increased risk of macular disease after 7 years of taking the drug.  The data used in the study was from two different groups of people who used pentosan polysulfate sodium. In the first group, 3,012 people used the medication for 5 years. In the second group 1,604 people used the medication for 7 years.

November 2019

Another case report published in Ophthalmic Surgery, Lasers, and Imaging Retina was done in November 2019 by Drs. Demetrios G. Vavvas and Rachel M. Huckfeldt. One of their patients experienced worsening maculopathy even after having been off the medication for over 6 years.

June 2020

Janssen Pharmaceutical Companies added pigmentary maculopathy as one of the risks of taking Elmiron. This was a new addition to the warning label that many plaintiffs claim should have been included from the start.

References

Hanno PM. “Analysis of long-term Elmiron therapy for interstitial cystitis”, US National Library of Medicine National Institutes of Health. Accessed April 30, 2020.

Jenelle Foote, Adam Hanif, Nieraj Jain. “Chronic Exposure to Pentosan Polysulfate Sodium Is Associated With Retinal Pigmentary Changes and Vision Loss”, The Journal of Urology. Accessed April 30, 2020.

Joseph T Nezgoda, MD MBA, Nieraj Jain, MD. “Pigmentary Maculopathy From Chronic Exposure to Pentosan Polysulfate Sodium”, American Academy of Ophthalmology. Accessed April 30, 2020.

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