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Elmiron Class-Action Lawsuit Filed in Federal Court

A federal class-action lawsuit on Elmiron was filed in October 2020. Its plaintiffs allege that it causes pigmentary maculopathy. This comes after recent studies have reported on Elmiron’s association with retinal damage.

These Elmiron eye damage lawsuits are expected to explode as people are learning that their eye injuries may be associated with Elmiron.  This could be an extremely large mass tort and it has earned the interest of drug injury lawyers everywhere.


Pentosan polysulfate sodium (PPS), more commonly known as Elmiron, is primarily used to treat bladder pain and interstitial cystitis. Janssen Pharmaceuticals manufactures this drug. The FDA approved it in 1996. It comes in a 100mg capsule. The recommended daily dose is 300 mg. Elmiron is contraindicated with anticoagulants and NSAIDs. It is not recommended for individuals who are pregnant, about to undergo surgery, or suffering from liver problems.

According to Elmiron’s website, its common side effects include:

  • Alopecia
  • Diarrhea
  • Nausea
  • Bloody stool
  • Headaches
  • Rashes
  • Upset stomach
  • Abnormal liver function test results

Studies on PPS’ association with eye damage

Emory Eye Center physicians were among the first to publicly report this association. In a May 2018 study, they found that chronic PPS use was associated with pigmentary maculopathy signs. They examined six patients’ medical records. The patients’ ages ranged between 37 and 62 years. Their exposure duration ranged between 144 and 240 months. The physicians found that all but one patient showed retinal pigment epithelium (RPE) signs. Four of them reported reading difficulties. They also found that their prior medical histories or diagnostic tests could not explain these issues. The ophthalmologists concluded that additional research was needed to examine the cause of pigmentary maculopathy in Elmiron patients.

Around October 2019, three Kaiser Permanente-affiliated ophthalmologists reported on Elmiron’s association with eye damage. They presented these findings at the American Academy of Ophthalmology’s annual meeting. The ophthalmologists discovered 140 patients who took an average of 5,000 pills within 15 years. Ninety-one of them agreed to an examination. The ophthalmologists took images of their retinas. They found that 22 out of 91, about 25 percent, showed eye damage. They also found that the eye damage rate correlated with the consumed amounts. It was 11 percent in patients who took 500 to 1,000 grams and 42 percent in patients who took over 1,500 grams.

In a July 2020 JAMA article, Emory University-affiliated scientists concluded that PPS-associated maculopathy may persist for at least a decade after its users stop taking it. The study looked at 11 female patients with Elmiron-associated maculopathy. All of them were between 53 and 63 years old. The scientists found that their conditions failed to improve after they stopped taking Elmiron. They even found that nine patients, about 82 percent, experienced worsening vision issues. This appears to show that Elmiron’s effects may continue to last a long time in former users.

June 2020 FDA Warning Label Update

On June 16th, 2020, the FDA updated its warning information on Elmiron to include its association with pigmentary maculopathy. It recommends that patients have their ophthalmologic history examined before taking the drug. The FDA also recommends that Elmiron patients undergo regular retinal examinations to timely detect retinal changes.

British and Canadian government warnings on Elmiron

The FDA’s Elmiron warning comes a year after both Canada and the United Kingdom announced theirs. Around September 2019, the British government issued a drug safety update on Elmiron’s association with pigmentary maculopathy. The Canadian government issued its warning a month later. Both warnings recommended regular eye examinations to timely detect pigmentary maculopathy. They also recommended stopping treatment once the physicians confirm pigmentary maculopathy.

Elmiron Class-Action in the U.S. District Court in Florida

On October 9th, several former Elmiron users filed a class-action lawsuit against its manufacturers and distributors in the U.S. District Court in the Southern District of Florida. The defendants included Janssen Pharmaceuticals, Teva Pharmaceuticals, Johnson & Johnson, Alza Corporation, and Bayer. The individuals claimed they suffered from Elmiron-associated pigmentary maculopathy. They argued that their vision problems could have been avoided had the manufacturers included prior warnings. They alleged that they should have known of the drug’s pigmentary maculopathy risk. The individuals also alleged that its manufacturers failed to warn Elmiron’s prescribers and users of this risk. They claimed early detection, monitoring, and routine examinations are crucial to identifying and alleviating Elmiron-associated vision problems.  The individuals requested that the court require the manufacturers to carry out a medical monitoring program to detect Elmiron’s visual side effects.