Screening Recommended for Evidence of Elmiron-Related Maculopathy

For many people with interstitial cystitis, also known as painful bladder syndrome, the condition is incapacitating, keeping them up at night with uncomfortable feelings of bladder pressure, bladder pain, and urinary urgency. Unfortunately, the only medication approved to treat interstitial cystitis has been linked to retinal maculopathy, a novel eye disease that can lead to retinal deterioration, vision loss, and possibly even permanent blindness. These vision symptoms have been so closely tied to Elmiron exposure, that ophthalmologists now recommend screening in Elmiron patients for any evidence of retinal injury. If you or a loved one was diagnosed with maculopathy after taking Elmiron or pentosan polysulfate sodium, contact Consumer Safety Watch today. We have seen how devastating maculopathy side effects allegedly caused by Elmiron use can be, and we are here to help.

Why is Elmiron Prescribed?

Elmiron (pentosan polysulfate sodium) is a prescription drug manufactured by Janssen Pharmaceuticals and prescribed for interstitial cystitis (IC), a chronic bladder condition that belongs to a spectrum of diseases known as painful bladder syndrome. Elmiron first entered the market in the United States in 1996, and quickly become the go-to treatment for patients with IC experiencing chronic pain and a persistent, urgent need to urinate. However, the makers of Elmiron now face a great deal of scrutiny in light of increasing reports of a rare eye disease called retinal maculopathy associated with chronic exposure to the interstitial cystitis drug.

Cases of Retinal Maculopathy Reported in Elmiron Users

The first reported cases of pigmentary maculopathy potentially associated with exposure to Elmiron were documented by doctors at Atlanta, Georgia’s Emory Eye Center in 2018. Six patients with interstitial cystitis presented to the clinic with maculopathy symptoms between 2015 and 2017, and the only factor all six patients had in common was the use of pentosan (Elmiron). In the years since, ophthalmologists across the country have documented cases of retinal maculopathy in Elmiron patients who took the drug for long periods of time. However, because Elmiron is currently the only oral medication FDA-approved to treat IC, many Elmiron users do take the drug for long periods of time. Among the eye symptoms that may be related to Elmiron treatment are vision loss, blurred vision, difficulty reading, and difficulty adjusting to dim lighting, and these symptoms may progress even after the drug treatment has been terminated.

Screening Recommendations for Elmiron Patients

Reports of irreversible retinal damage associated with Elmiron use prompted the manufacturer to add a warning to the Elmiron label highlighting the risk of retinal pigmentary changes in Elmiron patients. “Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of Elmiron,” the warning reads. “Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use.  While the etiology is unclear, cumulative dose appears to be a risk factor.” In light of the alleged risk of retinal maculopathy associated with the widely used IC drug, there are a new set of Elmiron screening recommendations healthcare providers are advised to follow when prescribing Elmiron to patients, especially those with pre-existing ophthalmologic conditions. These recommendations include the following:

  • Obtaining detailed ophthalmologic history in all patients prior to beginning Elmiron treatment;
  • Considering genetic testing for patients with a family history of hereditary pattern dystrophy;
  • For patients with pre-existing ophthalmologic conditions, obtaining a comprehensive baseline retinal examination prior to starting therapy;
  • Obtaining a baseline retinal examination for all Elmiron patients within six months of initiating treatment and periodically during the course of treatment;
  • If pigmentary changes in the retina develop, reevaluating the risks and benefits of continuing treatment, since these changes may be irreversible; and
  • Continuing follow-up retinal examinations, given that retinal and vision changes may progress even after cessation of treatment.

What to Do if You are Experiencing Maculopathy Symptoms

In most cases, Elmiron patients have not experienced symptoms of retinal maculopathy until 10 to 15 years after starting the drug treatment. And because interstitial cystitis typically affects people in their 40s, many patients who have developed maculopathy while taking Elmiron have had their eye disease misdiagnosed as macular degeneration, which happens when aging causes damage to the part of the retina that controls sharp, straight-ahead vision. According to Dr. Christina Y. Weng, an ophthalmology professor at the Baylor College of Medicine, the easiest way to differentiate between Elmiron-related maculopathy and age-related macular degeneration is to do a thorough review of the patient’s medication history to determine whether the patient previously took or is taking Elmiron. It is important to note that, as the updated Elmiron label states, “retinal and vision changes [associated with Elmiron] may progress even after cessation of treatment,” which means these debilitating vision symptoms may even occur in patients who are no longer taking the drug.

If you or someone you love is experiencing symptoms of retinal maculopathy and you believe Elmiron to be the cause, do not hesitate to speak to a knowledgeable Elmiron injury attorney about your legal options. You may have grounds to file an Elmiron lawsuit against Janssen Pharmaceuticals, in order to pursue financial compensation for your injuries and losses. Contact Consumer Safety Watch as soon as possible to find out how we can help.

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