Elmiron® (pentosan polysulfate sodium), a blood thinning medication that has been on the market since the mid-1990s, has long been used to treat painful bladder syndrome (interstitial cystitis). It is the only Food and Drug Administration (FDA) approved pill to treat the condition. But in recent years, it has come to light that taking Elmiron has been directly linked to the development of a serious eye condition called retinal maculopathy.

Retinal maculopathy is a disease of the retina that causes severe vision problems, pain, and discomfort of the eyes. In serious cases, blindness can occur. The use of Elmiron, especially long-term, can cause eye problems even after the drug is stopped.

Studies Have Linked Elmiron Exposure to Eye Damage

Over 100 adverse event reports were filed by Janssen Pharmaceuticals, the manufacturer of Elmiron, between 1997 and 2019 regarding eye-related injuries caused by the medication. Beyond injuries reported to the FDA, multiple scientific studies have identified a direct link between patients taking Elmiron and serious retinal maculopathy. Here are just a handful of such findings:

  • A study published in the American Academy of Ophthalmology found that approximately one quarter of patients with significant Elmiron exposure showed definitive signs of eye damage.
  • Research published in the Canadian Urological Association Journal noted that it is possible that Elmiron is directly toxic to the eye’s pigmented layer of retina.
  • Harvard Medical School researchers identified instances of Elmiron-associated maculopathy progressing for six years after the discontinuation of the medication.

Despite these findings, the FDA has yet to recall Elmiron. In fact, the agency did not update Elmiron’s warning label in the United States to include retina damage until June 2020:

Pigment changes in the retina of the eye (also referred to as pigmentary maculopathy in medical journal articles) have been reported with long-term use of ELMIRON®. While the cause of the pigmentary changes is unclear, continued long term dosing with ELMIRON® may be a risk factor.

Click here to read Elmiron’s full warning label, which goes into greater detail about the eye-related symptoms associated with Elmiron.

Signs of Elmiron-induced Maculopathy

Because many patients who take Elmiron are middle aged to older adults, eye-related symptoms related to the medication can be easily mistaken for age-related eyesight degeneration. The following are some of the complications that can emerge from taking Elmiron:

  • Blindness
  • Blurred vision
  • Dark spots or vision loss in the central field of vision (paracentral scotoma)
  • Difficulty reading
  • Difficulty adjusting to darkness or dimmed lighting
  • Dull or muted colors
  • Eye pain
  • Straight lines appear to be curved or rounded (metamorphopsia)

Have You Experienced Vision Problems or Eye Pain After Taking Elmiron?

If you have taken Elmiron to reduce bladder pain and suffered eye pain or vision issues, you may be eligible for financial compensation. The experienced legal team at The Law Firm of Kitrick, Lewis & Harris Co. can help you evaluate your specific case with no out-of-pocket cost to you. Contact us today to get your free evaluation.