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The Canadian Journal of Ophthalmology recently published new evidence linking the interstitial cystitis drug Elmiron (pentosan polysulfate sodium or PPS) with a significantly increased risk of vision damage. This, as the number of Elmiron lawsuits, continues to rise in both consolidated litigations in New Jersey and state courts nationwide.

New Study Confirms Link Between Elmiron and Vision Damage

Elmiron (PPS) is the only FDA-approved drug to treat interstitial cystitis (IC), a painful and incurable bladder disease. Symptoms include chronic pelvic pain, frequent urination, pain and pressure in the bladder and other areas like the urethra and lower back, urinary urgency, and pain during sexual intercourse.

Elmiron can help ease these symptoms but it must be taken consistently to continue providing relief. That means patients typically take it for many years on a regular basis.

In the study, researchers gathered data on patients who had been treated with PPS at the University of California, Los Angeles, and then screened with retinal imaging to check for any damage to the macula. This is the part of the eye that is responsible for central vision. It sits right in the center of the retina, which is a layer of light-sensitive tissue at the back of the eye.

The results showed that 20 percent of those patients who had been screened showed signs of PPS-associated maculopathy, a unique type of macular damage seen with other patients taking PPS. The researchers also found that those who did not show signs of macular damage had taken lower doses of PPS and for shorter periods.

The prevalence of 20 percent, according to the scientists, “suggests a significant risk of macular toxicity for PPS-treated patients.” They added that exposure to more PPS (in higher doses or for longer periods) was associated with more severe damage, and recommended that any patient taking PPS get an initial eye examination and annual retinal imaging thereafter.

Manufacturer Drags Feet on Warning Patients About Risk of Vision Loss

This is one of many studies that have linked the use of Elmiron with vision damage. In every instance, the damage is unique and unlike any other type of macular damage. The drug causes small dark spots to appear on the macula and retina. This is why scientists call this particular type of damage “pigmentary” maculopathy.

Scientists at Kaiser Permanente, for instance, found that of the 140 of their patients who had taken Elmiron for a minimum of 5 years, 22 (24 percent) showed eye damage. The greater the quantity of Elmiron taken, the greater the damage. Another study followed showing that patients taking PPS for seven years or longer were at an increased risk of having maculopathy.

Elmiron manufacturer Janssen Pharmaceuticals was aware of the risks for years but failed to take action until pressured to do so by consumer groups and individuals filing Elmiron lawsuits. Finally, in June 2020, the FDA approved an updated warning on the label that alerts patients and doctors to the potential risk for eye damage.

Meanwhile, individuals who took Elmiron for years and then were diagnosed with vision loss have filed lawsuits against Janssen seeking to hold the company liable for damages. All federal cases were consolidated in the U.S. District Court for the District of New Jersey in December 2020.

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