Pentosan Polysulfate Sodium

Pentosan polysulfate sodium (Elmiron) is the only oral medicine that is FDA approved for treating the pain and discomfort of IC/BPS.

Pentosan Polysulfate Sodium (Elmiron) and IC/BPS

In double-blind, placebo controlled clinical trials, 38 percent of patients treated with Elmiron for three months reported improvement of their IC/BPS symptoms. In open-label trials, 61 percent of patients reported improvement.

Elmiron is thought to work by restoring a damaged, thin, or “leaky” bladder surface. This surface (glycosaminoglycans, or GAG layer) is composed of a coating of mucus, which protects the bladder wall from bacteria and irritating substances in urine. It is believed that Elmiron functions as a synthetic GAG layer, but the drug’s mechanical action in IC is unknown.

Dosage & Treatment Plan

A usual dosage for IC/BPS patients is 100 mg. of Elmiron three times a day, for a total of 300 mg/day.

Some patients report symptom relieve in three to four weeks. For others, it may take up to six months to see improvement. Patients are urged to continue therapy for at least six months before discontinuing treatment. Pain subsides first, but a decrease in urinary frequency may take six to nine months. It may also be necessary to use other medicines, such as low-dose tricyclic antidepressants, antihistamines, etc., along with Elmiron.

Potential Side Effects

The most current information on documented side effects associated with using pentosan polysulfate sodium or ElmironⓇ can be found on the U.S. Food and Drug Administration’s (FDA) website (specifically, the most current Label). Importantly, the FDA label for Elmiron (as of March 2021) includes a warning regarding pigmentary maculopathy (or pigmentary changes to the retina). These pigmentary changes can result in “difficulty reading, slow adjustment to low or reduced light environments, and blurred vision.” The FDA recommends that a detailed ophthalmologic history be obtained before starting Elmiron, along with regular retinal examinations. Additional recommendations are made for those with a personal or family history of ophthalmologic conditions.

While initial studies indicated mild gastrointestinal side effects, more recent studies have begun to document a potential association between the use of Elmiron and the development of symptoms consistent with inflammatory bowel disease or irritable bowel syndrome (Anderson et al., 2023; Jung et al., 2023; Satina et al., 2024). While these studies do not document a causal relationship between taking Elmiron and the development of these symptoms/conditions, patients considering taking the drug or who are already on it (and especially those who may be experiencing gastrointestinal symptoms) should be aware of this new data.

In all cases, the ICA recommends that patients seek the counsel of their healthcare provider team before trying anything new or if they have concerns about the continuation of any particular treatment strategy. 

References

Anderson J, Frost S, Keyashian K, Modiano N. Pentosan Polysulfate-Associated Dysplasia in Patients With Inflammatory Bowel Disease: A Case Series. Am J Gastroenterol. 2023;118(5):905-908. doi:10.14309/ajg.0000000000002137

*Jung EH, Zheng W, Weiss RJ, et al. Colopathy Associated with Pentosan Polysulfate Use. Preprint. medRxiv. 2023;2023.04.03.23288071. Published 2023 Apr 4. doi:10.1101/2023.04.03.23288071

Santina A, Feo A, Bousquet E, et al. Pentosan polysulfate sodium maculopathy: Final analysis of a prospective cohort, updated review, and association with inflammatory bowel disease. Surv Ophthalmol. Published online December 12, 2024. doi:10.1016/j.survophthal.2024.12.002

*This is a preprint article and has not been peer-reviewed by a journal.

Pregnancy & Children

Because studies have not been performed in pregnant women, the manufacturer recommends that the drug not be used in pregnancy. The safety and effectiveness of Elmiron use in children has not been established.

You can get more information on Elmiron by calling toll-free 888-ELMIRON or visiting Ortho McNeil or the Elmiron healthcare provider site.

Medications