We Take a 2021 Look at the Findings on Increased Risk of Elmiron-associated Pigmentary Maculopathy


(Posted by Tom Lamb at Drug Injury Watch)


At the 2021 Southeastern Educational Congress of Optometry (SECO) meeting in Atlanta GA, Nate Lighthizer, OD, FAAO, stated what is rather well known by now, that long-term use of Elmiron, a drug used to treat interstitial cystitis, has been linked to pigmentary maculopathy. During his SECO presentation about the ocular effects of systemic medications including Elmiron toxicity, he summarized the increased risk of Elmiron-associated pigmentary maculopathy.

From this Healio Optometry News article, “Check for maculopathy in patients being treated for interstitial cystitis“, we get this report of Dr. Lighthizer’s SECO presentation:

Researchers at Emory University looked at 219 patients with interstitial cystitis, “and everyone who had pigmentary maculopathy was taking pentosan polysulfate (PPS),” he said.

In the study, the mean age of ocular toxicity was 60 years, and the median duration of PPS intake was 15 to 18 years, Lighthizer said.

“The study also suggested that chronicity of exposure plays a role,” he continued. “At the 5-year time point of continuous treatment, there was a trend for increased risk, although it wasn’t statistically significant.”

The most common presenting symptoms were blurred vision (48%), prolonged dark adaptation (48%) and metamorphopsia (11%). Median duration of symptoms was 4 years, and median visual acuity was 20/25….

According to guidelines developed by Emory University, a baseline exam for these patients should consist of dilated fundus exam, [optical coherence tomography (OCT)], fundus photos and fundus autofluorescence (FAF), “the most important test,” Lighthizer said. An annual exam should be conducted after 5 years of medication use….

Lighthizer added that many of these cases of Elmiron toxicity may have previously masqueraded as other similar-looking conditions such as age-related macular degeneration and pattern dystrophy.

“The fundus findings in PPS-associated maculopathy are subtle yet exhibit a distinctive clinical phenotype on multimodal imaging that’s best appreciated by using FAF,” he concluded.

In the March 2021 edition of Current Opinion in Ophthalmology, there is a medical journal article that elaborated on the degree of increased risk of Elmiron-associated pigmentary maculopathy. Here is the Abstract for “Update on maculopathy secondary to pentosan polysulfate toxicity” which provides some important details:

Purpose of review: The aim of the present review is to provide a comprehensive summary of available knowledge regarding toxic maculopathy secondary to [Elmiron, or pentosan polysulfate sodium (PPS)].

Recent findings: [Elmiron (PPS) toxicity] was described in 2018, and additional studies characterize it as dysfunction of the retinal pigment epithelium centered on the posterior pole, which can progress despite drug cessation. Requisite exposure can be as little as 0.325 kg and 2.25 years but averages closer to 1–2 kg and 10–15 years. Multimodal imaging should include near-infrared reflectance, optical coherence tomography, and fundus autofluorescence. Cross-sectional studies demonstrate evidence correlating cumulative dosing and the likelihood/severity of maculopathy. Early estimates of prevalence range from 12.7 to 41.7% depending on dosing, with overall rates around 20%.

Summary: Reasonable evidence associates maculopathy with extended exposure to [Elmiron (PPS)], with an average reported incidence of around 20% in patients with long-term exposures. Patients with unexplained retinal pigment epithelium changes and difficulty with dark adaptation should be questioned regarding [Elmiron (PPS)] exposure, and patients with known exposure to [Elmiron (PPS)] should be examined. Further research is needed to refine screening protocols. Currently, providers should consider baseline examination and examination at 5 years and/or 500 g of exposure followed by yearly screening.

As regards Elmiron toxicity and, in particular, the increased risk of Elmiron-associated pigmentary maculopathy, we point out a rather remarkable statement in this 2021 Elmiron medical journal article Abstract: It is estimated that around 20% of interstitial cystitis patients with long-term Elmiron use may develop maculopathy.

It is important to know that a patient does not have to have current Elmiron use right up until the time when their pigmentary maculopathy is diagnosed in order for it to be considered Elmiron-related eye damage.

We are currently investigating possible Elmiron lawsuits for patients with past Elmiron use diagnosed with pigmentary maculopathy. If we can be of assistance to you with an Elmiron-related eye damage legal case, you can submit an online Elmiron Case Evaluation Form or you can call us on our toll-free number: 800-426-9535.

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