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Elmiron (pentosan polysulfate sodium) is approved to relieve bladder pain or discomfort caused by interstitial cystitis. However, research suggests Elmiron may cause maculopathy, a severe eye disorder that can lead to permanent blindness.

Elmiron: Background

Janssen Pharmaceuticals received U.S. Food & Drug Administration (FDA) approval to market Elmiron in 1996. The drug is indicated to relieve pain and discomfort associated with interstitial cystitis, a chronic, progressive and debilitating urinary bladder disease that affects more than 1 million people in the United States, primarily women.

Elmiron is taken as one 100mg tablet three times per day. The capsules should be taken with water at least on hour before meals or two hours after meals.

Doctors should reassess Elmiron patients after three months to determine if their condition has improved. Treatment may continue for another three months if no improvement is noted and the patient has not experienced any Elmiron side effects. The risk/benefit profile of longer Elmiron treatment remains unknown.

How Does Elmiron Work?

It is believed that Elmiron works 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. While it appears Elmiron functions as a synthetic GAG layer, the drug’s mechanical action in interstitial nephritis is unknown.

Some patients who take Elmiron have reported relief after just four weeks, but it may take up to six months to experience symptom improvement. Pain generally subsides at first, but a decrease in urinary frequency may not occur for six to mine months.

Some patients may need to take low-dose tricyclic antidepressants, antihistamines, or other medications with Elmiron.

Elmiron Safety Considerations

Patients considering Elmiron should tell their doctor if they have:

• Bleeding or blood clotting disorder
• History of aneurysm or stroke
• Stomach ulcer
• Intestinal polyps
• Diverticulitis
• Liver disease

Prior to treatment, they should also let their physician know if they take any medications that may increase the risk of bleeding, including blood thinners, anti-clotting medications, or NSAIDs such as ibuprofen, naproxen, or indomethacin.

Elmiron Side Effects

Once treatment begins, patients taking Elmiron should call their doctor right away if they experience:

• Easy bruising or unusual bleeding such as nosebleed.
• Blood in urine or stools.
• Rectal bleeding.
• Coughing up blood.
• Bleeding gums.
• Feeling that they might pass out.

Less serious Elmiron side effects may include:

• Hair loss
• Nausea, diarrhea, stomach pain
• Headache
• Mild dizziness
• Depressed mood
• Mild itching or skin rash

Recent medical research has also linked Elmiron to maculopathy, a disease of the retina that affects the macula, the part of the eye associated with highly sensitive, accurate vision.

Between 1997 and 2019, the FDA’s Adverse Event Reporting System (FAERS) received 100 reports of eye disorders related to the use of Elmiron. Eight cases were considered serious and 22 mentioned various forms of maculopathy.

Recent Research on Elmiron and Maculopathy

In 2018, researchers at the Emory Eye Center in Georgia reported that six patients who were taking Elmiron for about 15 years had developed unusual changes in their macula. Because nothing in the patients’ medical histories or diagnostic tests could explain the pattern of abnormalities, the researchers suspected Elmiron was to blame.

Those findings prompted ophthalmologists at Kaiser Permanente to review records on their own Elmiron patients. In doing so, they discovered that a woman on long-term treatment had been misdiagnosed with retinal dystrophy.  After discovering that single case, the physicians decided to review Kaiser Permanente’s entire database of 4.3 million patients. They were able to identify 140 people who had taken more than 5,000 Elmiron tablets over a period of 15 years.

Ninety-one of those individuals ultimately agreed to undergo an exam. The ophthalmologist took detailed images of the back of their eyes and then divided the images into three categories: normal, possible abnormality, definite abnormality. Twenty-two of the 91 patients showed clear signs of drug toxicity. The rate of toxicity rose with the amount of Elmiron consumed, from 11% of those taking 500 to 1,000 grams to 42% of those taking 1,500 grams or more

In November 2019, a report published in  Ophthalmic Surgery, Lasers and Imaging Retina  raised concern that Elmiron-induced maculopathy could continue long after treatment ended. The paper detailed the case of a 69-year-old woman who stopped using Elmiron at the age of 62, following a diagnosis of maculopathy. Unfortunately, exams conducted when she was 67 and again when she as 69 showed the degeneration continued to progress, even though she was no longer taking the drug.