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Elmiron

Elmiron, or pentosan polysulfate sodium, is an oral prescription drug used to treat discomfort or bladder pain associated with interstitial cystitis, or IC, a chronic condition that causes bladder pain and pressure. The most common side effects of Elmiron are hair loss, diarrhea and nausea. Headache, abdominal pain and upset stomach may also occur.

Janssen Pharmaceuticals manufactures Elmiron, and the U.S. Food and Drug Administration originally approved it for sale in 1996. It was approved under the Orphan Drug Act, or ODA. The ODA gives special status and incentives to sponsors, or manufacturers, of medications that treat rare diseases.

Currently, it’s the only oral drug approved to treat bladder pain and discomfort associated with IC, and it’s not available in generic. Since its release, it’s estimated that hundreds of thousands of people have used the drug, according to HealthDay. Most people who use the drug are women, and the drug is most often used long-term.

The majority of Elmiron side effects are mild, but new reports suggest the drug could be toxic to the retina, the tissue behind the eye that senses light.

How Pentosan Polysulfate Sodium Works

Researchers don’t know exactly how pentosan polysulfate sodium works, but they believe it works by protecting the bladder from irritants in urine. Elmiron doesn’t work like other pain relievers like Tylenol or non-steroidal anti-inflammatory drugs like ibuprofen, and it doesn’t work by stopping inflammation.

In people with IC, the bladder wall’s protective lining is damaged. This allows irritating substances in urine to cause inflammation in the bladder wall. Elmiron creates a barrier on the bladder wall to prevent irritation.

How Elmiron Works
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Elmiron is thought to work by protecting the bladder wall from irritants.

Does Elmiron Cure Interstitial Cystitis?

Elmiron doesn’t cure IC, but it does provide some relief from symptoms. Interstitial cystitis, or bladder pain syndrome, is a chronic condition that causes painful symptoms in the bladder. IC is common and affects between 1 to 4 million men and between 3 to 8 million women in the United States, according to the National Institute of Diabetes and Digestive and Kidney Diseases. Currently, there is no cure.

Researchers don’t know what causes IC, but certain activities, food and drinks may trigger symptoms. For example, people reported symptom flares with stress, intercourse, holding their urine or using tight undergarments.

Symptoms of IC include:
  • Pressure, mild discomfort or tenderness in the bladder, lower abdomen or pelvic area
  • Urinary urgency several times a day
  • Waking up several times at night to urinate
  • Burning sensation or pain
  • Urinating more often
  • Pain that gets worse until bladder is emptied
  • Pelvic floor muscle pain
  • Pain during or after sexual intercourse

How Well Does It Work?

Elmiron’s manufacturers tested the drug in two clinical trials in 2,627 patients. Of these trial participants, 2,343 were women, 262 were men and 22 were unknown. After three months in the second trial, 52 percent of the patients, or 1,307, had dropped out or were ineligible for analysis, according to the medication insert.

The results of these studies showed that Elmiron relieved pain in many patients. A majority of patients who had a response demonstrated pain relief by 3 months; however, a small percent of patients took up to 6 months to demonstrate pain relief.

But another study done on a smaller number of patients by G.R. Sant and colleagues published in The Journal of Urology found that oral pentosan polysulfate sodium didn’t provide much benefit to the majority of IC patients.

Side Effects

Elmiron has a few common side effects, and most of them are mild. Because it’s a mild blood thinner, it may also cause bruising. Call your doctor right away if these side effects persist or bother you or if you have blood in your stool.

Common side effects include:
  • Abnormal liver function tests
  • Blood in the stool
  • Bruising
  • Diarrhea
  • Dizziness
  • Hair loss
  • Headache
  • Nausea
  • Rash
  • Upset stomach

Some people reported pigmentary changes in the retina, also called pigmentary maculopathy, with long-term use of Elmiron. Researchers don’t know what causes it, but it can cause problems with reading, blurred vision and difficulty adjusting to low lighting. Call your doctor if you notice changes in your vision while taking this medicine.

Dosage, Instructions and Precautions

The recommended daily dose for Elmiron is one 100 mg capsule by mouth three times a day for a total of 300 mg daily. The capsule should be taken with water at least one hour before meals or two hours after meals.

After three months of taking Elmiron, the patient should contact their health care provider for an evaluation of how well the drug is working. If there is no improvement in IC symptoms and there are no serious side effects, the health care provider may recommend another three months of treatment.

Precautions

Elmiron is a weak anticoagulant. This means it works like a blood thinner and makes it harder for blood to clot. Its strength is about one-fifteenth the strength of heparin. Rectal hemorrhage, gum hemorrhage and bruising have been reported.

Patients about to have surgery, who have symptoms of bleeding or who are taking other drugs that may increase bleeding — blood thinners, aspirin, or non-steroidal anti-inflammatory drugs — should tell their health care providers right away.

Some patients experienced mildly elevated liver enzymes that occurred three to 12 months after starting treatment. Researchers haven’t tested Elmiron in people with liver insufficiency, and people with liver problems should use the drug with caution.

Pregnancy and Breastfeeding

Elmiron should be used in pregnancy only if clearly needed, according to the drug’s label.

Reproduction studies in mice and rats did not reveal evidence of impaired fertility or harm to the fetus from Elmiron. However, adequate and well-controlled studies have not been performed in pregnant women, and animal studies are not always predictive of human response.

Nursing women should also exercise caution. Many drugs are excreted in human milk, and it is not known whether Elmiron can pass through breast milk.

Drug Interactions

Elmiron’s medication insert doesn’t list any drug interactions. But patients should tell their health care provider about all drugs, vitamins and any herbal supplements they are taking — especially any medication that may increase bleeding risk.

Lawsuit Information
Lawsuits claim that people who took Elmiron experienced vision problems including blurred vision, maculopathy, retinopathy and vision impairment.
View Lawsuits

Lawsuits for Eye Damage

Elmiron’s medication insert didn’t list any warnings about eye damage or an increased risk of eye disease until Janssen added a warning about pigmentary maculopathy in June 2020, according to lawsuits.

One of the first case reports appeared in the Journal of Urology in 2018. Dr. William A. Pearce and colleagues wrote that long-term use of the drug led to “injury to the retina and the underlying retinal pigment epithelium,” according to the IC Network. Since that report, additional studies have been done to determine whether this is a true effect of the drug. Results have been mixed; however, there is suggestion that long-term use of Elmiron can cause eye damage. Canadian researcher Derrick Wang and his colleagues recommend all patients have a thorough eye examination before starting Elmiron and once a year after that to check for any changes.

In 2019, Drs. Rachel M. Huckfeldt and Demetrios G. Vavvas published a case report in Ophthalmic Surgery, Lasers and Imaging Retina of a patient whose pentosan polysulfate sodium-related maculopathy continued to get worse 6 years after stopping the drug.

Lawyers are currently filing Elmiron lawsuits on behalf of people who took the drug and experienced vision problems including blurred vision, maculopathy, retinopathy and vision impairment.

Elmiron Pill
Elmiron Facts
  1. Used to Treat Pain and discomfort associated with interstitial cystitis, or IC
  2. Manufacturer Johnson & Johnson’s Janssen Pharmaceuticals subsidiary
  3. Active Ingredient Pentosan polysulfate
  4. Administration Route Oral
  5. Available Strength 100 mg
  6. Dosage Form Capsule
  7. Drug Class Genitourinary Tract Agents
  8. Is Available Generically False
  9. Is Proprietary True
  10. RxCUI 155043

Please seek the advice of a medical professional before making health care decisions.

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Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for nearly a decade. She focuses on various medical conditions, health policy, COVID-19, LGBTQ health, mental health and women’s health issues. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • Member of American Medical Writers Association (AMWA) and former Engage Committee and Membership Committee member
  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates
  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine
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17 Cited Research Articles

Drugwatch.com writers follow rigorous sourcing guidelines and cite only trustworthy sources of information, including peer-reviewed journals, court records, academic organizations, highly regarded nonprofit organizations, government reports and interviews with qualified experts. Review our editorial policy to learn more about our process for producing accurate, current and balanced content.

  1. FDA Adverse Event Reporting System (FAERS) Public Dashboard. (n.d.). Elmiron, pentosan polysulfate sodium. Retrieved from https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard
  2. Huckfeldt, R.M. & Vavvas, D.G. (2019). Progressive Maculopathy After Discontinuation of Pentosan Polysulfate Sodium. Retrieved from https://www.healio.com/ophthalmology/journals/osli/2019-10-50-10/%7B324bde2e-2389-4815-bf5e-fe3b2eb18062%7D/progressive-maculopathy-after-discontinuation-of-pentosan-polysulfate-sodium
  3. IC Network. (n.d.). Long-Term Pentosan (Elmiron) Use May Be Linked to Eye Disease. Retrieved from https://www.ic-network.com/long-term-pentosan-elmiron-use-may-be-linked-to-retinal-disease/
  4. Janssen Pharmaceutical Companies. (2018). Elmiron 100 MG Prescribing Information. Retrieved from http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/ELMIRON-pi.pdf?
  5. Janssen Pharmaceuticals. (2008). Learning about interstitial cystitis (IC) and your treatment plan. Retrieved from https://rosemark.net/wp-content/uploads/2015/11/interstitial-cystitis-information.pdf
  6. National Institute of Diabetes and Digestive and Kidney Diseases. (n.d.). Definition & Facts of Interstitial Cystitis. Retrieved from https://www.niddk.nih.gov/health-information/urologic-diseases/interstitial-cystitis-painful-bladder-syndrome/definition-facts
  7. National Institute of Diabetes and Digestive and Kidney Diseases. (n.d.). Symptoms & Causes of Interstitial Cystitis. Retrieved from https://www.niddk.nih.gov/health-information/urologic-diseases/interstitial-cystitis-painful-bladder-syndrome/symptoms-causes
  8. National Institutes of Health and National Institute of Diabetes And Digestive And Kidney Diseases. (2003, August 14). Interstitial cystitis study finds limited benefit in two oral drugs. Retrieved from https://www.eurekalert.org/pub_releases/2003-08/niod-ics081403.php
  9. Pearce, W. A., Hanif, A.M. & Jain, N. (2018). Re: FDA BRUDAC 2018 Criteria for Interstitial Cystitis/Bladder Pain Syndrome Clinical Trials: Future Direction for Research. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/30081020
  10. Preidt, R. (2019, October 15). Bladder Drug Can Cause Eye Damage: Study. Retrieved from https://www.usnews.com/news/health-news/articles/2019-10-15/bladder-drug-can-cause-eye-damage-study
  11. Sant, G.R. et al. (2003). A pilot clinical trial of oral pentosan polysulfate and oral hydroxyzine in patients with interstitial cystitis. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/12913705
  12. U.S. Food and Drug Administration. (n.d.). Search Orphan Drug Designations and Approvals: Pentosan polysulfate sodium. Retrieved from https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=1784
  13. Wang, D. et al. (2020). Pentosan-associated maculopathy: prevalence, screening guidelines, and spectrum of findings based on prospective multimodal analysis. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/31973791
  14. Ludwig, CA. et al. (2020). Pentosan polysulfate sodium exposure and drug-induced maculopathy in commercially insured patients in the United States. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/31899034
  15. Jain, N. et al. (2019). Association of macular disease with long-term use of pentosan polysulfate sodium: findings from a US cohort. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/31694837
  16. Hanif, AM. et al. (2019). Phenotypic spectrum of pentosan polysulfate sodium-associated maculopathy: a multicenter study. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/31486843
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