Kim Gale  |  October 27, 2021

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Elmiron Overview

Elmiron (pentosan polysulfate sodium) is a prescription medicine for patients who suffer from interstitial cystitis, a chronic condition also known as painful bladder syndrome.

Women are most at risk of interstitial cystitis, which can cause pain ranging from mild to excruciating. The bladder is a hollow organ made of muscles. Its only purpose is to store urine. As the bladder collects urine, it expands. When the bladder becomes full, it sends a signal to the brain that triggers an urge to urinate.

Interstitial cystitis causes the body’s and brain’s signals to become confused. The patient feels the need to urinate more often, releasing a much smaller amount of urine than most people would. Patients might misinterpret the symptoms as indications of a urinary tract infection.

Unfortunately, the mechanism of Elmiron is not well understood. Doctors are not sure exactly how the drug manages interstitial cystitis symptoms. However, it is thought that the drug forms a layer on the bladder’s wall which protects the bladder from irritation.

Potential Side Effects

Like any medication, Elmiron is associated with side effects. Some patients experience less mild but bothersome side effects, such as thinning hair, diarrhea, stomach pain, headache, minor dizziness, depression or itchy skin.

Patients may also suffer from a serious allergic reaction to the medication, though these reactions are rare.  Other patients may experience weight gain and swelling due to excess fluid retention.

While Elmiron may reduce pain associated with interstitial cystitis, the medication also works as a mild blood thinner, which may increase the patient’s risk of bruising and bleeding. Elmiron may cause serious side effects because of the drug’s propensity to act as a blood thinner. The medication’s anticoagulant properties may lead to the following:

  • Nosebleed
  • Blood in urine or stools
  • Rectal bleeding
  • Coughing up blood
  • Bleeding gums
  • Feeling faint

Recently, the drug has been linked to long-term maculopathy that could lead to blindness.

Elmiron Linked to Vision Problems

The American Academy of Ophthalmology published an article in 2018 discussing six patients diagnosed with pigmentary maculopathy after taking Elmiron to treat interstitial cystitis. An update earlier this year noted that 10 patients had been identified with the eye issue since the original publication. All of the patients received treatment at Emory Eye Center between 2015 and 2017.

Maculopathy is a term to define injury or disease affecting the macula, which is the small spot in the retina responsible for our keenest vision. Dr. Nieraj Jain discovered the link between long-term use of Elmiron and maculopathy, which is best diagnosed through advanced retinal imaging.

Dr. Jain describes the condition as “pattern dystrophy,” which can take more than 10 years to develop.

Symptoms of the maculopathy — called pattern dystrophy or pigmentary maculopathy — can vary. In some patients, retinal pigmentation occurs when abnormal blood vessels creep under the retina, leaking blood that causes the macula to become scarred and damaged. Other patients develop vitelliform deposits that appear as yellow or orange spheres under the macula.

During an eye exam, an ophthalmologist also might notice darkened spots on the retina, indicative of potential macular degeneration.

Legal Issues

Patients who have suffered serious side effects such as maculopathy after taking Elmiron may be eligible for compensation through legal representation. An experienced personal injury attorney can help prove Elmiron manufacturer Janssen Pharmaceuticals was negligent in providing proper warnings of the drug’s potential side effects that adversely affected patients’ vision.

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