Two Recent Medical Articles on Vision Side Effects of Elmiron (pentosan polysulfate sodium, or PPS) for Interstitial Cystitis


(Posted by Tom Lamb at Drug Injury Watch)


Chronic use of Elmiron (pentosan polysulfate sodium, or PPS) for interstitial cystitis, also known as bladder pain syndrome, has been associated with maculopathy in patients. The mechanism for this link between Elmiron and maculopathy, however, is still not fully understood. And the diagnostic means for identifying a case of Elmiron and maculopathy early on is still evolving. In this post, we at some relatively recent research into the still-emerging drug safety issue of Elmiron and maculopathy.

According to “Screening needed for pentosan polysulfate sodium-associated maculopathy“, published on September 2, 2021, by Ocular Surgery News:

In most cases, retinal findings do not appear until a patient has been on [Elmiron] for 10 to 15 years, according to Elliott Sohn, MD, of the University of Iowa. Because patients generally start to present with interstitial cystitis in their 40s, once they start to develop maculopathy, it is easily confused with macular degeneration.

“The maculopathy appears to be dose dependent and most often seen when the patient has been on [Elmiron] for a total cumulative dose of 1,500 g,” Sohn said. “A lot more research needs to be done to better understand why and how this is happening, as well as the prevalence of it.”

Two medical journal articles published in 2021 have presented some of this needed research about Elmiron and maculopathy.

First, from the Abstract for this study report published in the February 11, 2021 edition of the medical journal Clinical Ophthalmology, “Maculopathy Secondary to Pentosan Polysulfate Use: A Single-Center Experience“:

  • Aim:  To investigate the prevalence of retinal pathology in patients with a history of exposure to [Elmiron (pentosan polysulfate sodium, or PPS)].
  • Results:  A total of 131 patients who were exposed to [Elmiron] and seen at the Northwestern Ophthalmology clinic were identified in the EHR. Forty patients of 131 had imaging. Patients with imaging or fundus examination suspicious for [Elmiron] maculopathy were placed into the suspect group. Of the 40 patients that had imaging, 5 (12.5%) had features suspicious for [Elmiron] maculopathy. Of the remaining 91, 5 (5.4%) had macular pigmentary changes described on fundus exam. Among the 10 patients in the suspect group, the average duration of [Elmiron] use was 4.2 years (range 0.3-11.6 years, interquartile range 5.5 years) and the average cumulative dose [of Elmiron] was 380g (range 29-1092g, interquartile range 132g).
  • Conclusion:  A novel drug-induced maculopathy has been associated with [Elmiron] use with a distinct clinical constellation that can be accurately identified with multimodal imaging.

Second, from the Abstract for this study report published in the September 1, 2021 edition of The Journal of Urology, “PD01-09 PATIENT PERCEPTION OF OCULAR RISK IN PENTOSAN POLYSULFATE USE FOR INTERSTITIAL CYSTITIS“:

  • RESULTS:  A total of 735 patients treated with [Elmiron] were identified, of which 95 completed screening at the Stein Eye Institute. Of the 95, 64 patients consented to the study. Of the 64 patients included in analysis, 37 were no longer taking [Elmiron]. Patients with maculopathy (n=10) were more likely to have discontinued [Elmiron] (n=8) compared to patients without maculopathy (p=0.03). Patients with confirmed ocular complications reported daily doses [of Elmiron] in excess of recommended 300 mg daily dose (590 mg versus 290 mg in those without, p<0.00001) and significantly greater mean lifetime cumulative doses [of Elmiron](671 g versus 3894 g, p=<0.00001). There were no significant differences in age, daily dose, lifetime [Elmiron] dose exposure, or perception of maculopathy risk in those continuing [Elmiron] compared to those who had discontinued [Elmiron]. Primary reasons for discontinuation of [Elmiron] were concern for ocular injury (41%), lack of efficacy or decreased benefit (32%), cost (16%), and other side effects (11%).
  • CONCLUSIONS:  While the mechanism of maculopathy in [Elmiron] use is not fully understood, this risk must be weighed against its potential benefit as a treatment for interstitial cystitis. Physicians should counsel patients on risk of ocular complication in long term and high dose [Elmiron] use, and consider alternative therapies and early ophthalmologic referral in patients with lifetime cumulative doses [of Elmiron] greater than 500 g.

Of course, we will continue to monitor this still-emerging drug safety issue of Elmiron and maculopathy.

Our law firm is investigating possible Elmiron drug injury lawsuits for cases of Elmiron causing eye problems such as retinal pigmentary changes and pigmentary maculopathy resulting in vision loss. Medical & Legal Information About Drug Side Effects
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