There are growing concerns of a significant increase risk of the development of atypical maculopathy and age-related macular degeneration (AMD) associated with prolonged use of Elmiron. Even more troubling is that Janssen made label changes in other countries to warn users of pentosane polysulfate sodium (PPS) about these injuries, but have yet to warn the American public about the risk of vision and eye related problems.

Elmiron (pentosyn polysulfate sodium) was approved by the FDA in 1996 for Baker Norton Pharmaceuticals, which was then acquired in 2002 by Janssen Pharmaceuticals (a wholly-owned subsidiary of Johnson & Johnson). The medication is widely prescribed for the treatment of a chronic condition called interstitial cystitis/bladder pain syndrome (IC/BPS).

A recent article in Ophthalmology in November 2018 by Pearce et al. uncovered a potential vision-threatening complication associated with the long-term use of PPS, an established treatment for interstitial cystitis and the only FDA-approved oral option, sold under the brand name Elmiron. A cohort study published in the British Journal of Ophthalmology in November 2019 showed a statistically significant increase of retinopathy, dry age-related macular degeneration (AMD), or drusen (yellow deposits under the retina, which can increase the risk of development of AMD) after seven years of use of PPS.

FDA Warning

Findings from a new study that was presented in 2019 at the American Academy of Ophthalmology. In Vora et al., researchers identified 140 patients from a Kaiser Permanente database who had taken an average of 5,000 pills over a fifteen-year period. Of that group, 91 agreed to be examined, of those, twenty-two patients, or roughly 25% showed clear evidence of AMD. Though this does not establish causation, some mechanisms of toxicity have been posited. In June of 2020, the FDA updated the warnings and precautions of Emilron to note that pigmentary maculopathy as an adverse reaction.  

Current Status Of Litigation

Elmiron lawsuits were centralized in December 2020 into MDL #2973 and transferred to the U.S. District Court of New Jersey. The proceedings will be supervised by MDL veteran Judge Brian R. Martinotti, who is also overseeing the Allergan Breast Implant – ALCL cancer coordinated proceeding #2921. Plaintiffs also applied for a Multicounty Litigation (MCL) in New Jersey State Court in September 2021, approval of this application is pending.