The bladder medication Elmiron has been linked to an increased risk of serious eye damage that can lead to blindness in some cases. Patients who were treated with Elmiron, or who are still taking the drug, and have developed retinal damage, blindness, or other vision problems may qualify to file a lawsuit.

Elmiron (pentosan polysulfate sodium) is prescribed to treat patients with a condition known as interstitial cystitis, or painful bladder syndrome. Elmiron is the only drug approved by the Food and Drug Administration to treat this disease. About 1 million patients in the U.S., mostly women, suffer from interstitial cystitis.

Elmiron Linked to Permanent Vision Loss from Retinal Damage

Several recent studies have linked Elmiron to an increased risk of permanent eye damage caused by retinal toxicity. The most serious type of vision loss associated with Elmiron is known as pigmentary maculopathy. In the United States and Europe, maculopathy (damage to the back of the retina) is the most common cause of blindness. However, pigmentary maculopathy is a rare form of this condition that appears to be unique to patients taking Elmiron.

Researchers have found that the risk of pigmentary maculopathy due to retinal toxicity among Elmiron users — and the seriousness of this vision loss — increases with the amount of the drug that has been taken. According to one study, 25% of patients who used Elmiron for more than six months, or who used higher doses of the drug, developed symptoms of serious and potentially permanent eye damage.

If vision loss caused by Elmiron is detected early, it can be stopped. But in patients who have taken higher doses of the drug — or who used this medication over an extended period — Elmiron may cause permanent vision loss that can lead to blindness.

Others Side Effects of Elmiron

The most common side effects linked to Elmiron are problems with reading small text and problems seeing in dimly-lit areas. Patients who stop taking Elmiron after they begin to develop vision problems may be able to stop their eyesight from becoming worse; however, some studies have shown that eye damage caused by Elmiron may continue to deteriorate for years after a patient has stopped taking the drug.

Other side effects that may indicate eye damage caused by Elmiron may include:

  • Difficulties reading small text
  • Dimmed vision
  • Paracentral scotoma
  • Problems seeing clearly in dim or dark lighting conditions
  • Reduced field of vision
  • Problems seeing objects that are close

Studies Linking Elmiron to Eye Damage

The first evidence linking Elmiron to an increased risk of eye damage was published in May 2018. Researchers at the Emory Eye Center found that several patients who had used Elmiron over an extended period had developed a type of pigmentary maculopathy that had never been observed before.

An expanded study published the following year by the Emory Eye Center found that the unique type of pigmentary maculopathy that had been observed in Elmiron users was not present in patients who had never been treated with the drug. Based on these findings, researchers advised Elmiron users who showed signs of eye damage to stop taking the drug. The researchers also advised patients taking Elmiron with no symptoms to visit their doctor for an eye exam to check for possible signs of pigmentary maculopathy.

The Emory Eye Center’s research linking Elmiron to an increased risk of eye damage prompted other scientists to start looking at the possible side effects of this drug. In October 2019, researchers at Kaiser Permanente published a study that found that patients who used Elmiron were at risk of developing retinal toxicity, and that this risk increased with higher doses of the drug. The following month, a case study published in the journal Ophthalmic Surgery, Lasers and Imaging Retina found that some patients who developed pigmentary maculopathy after using Elmiron may continue to experience a deterioration of their vision, even years after they stop taking the drug.

The breakthrough studies linking Elmiron to an increased risk of serious vision problems began in 2018. Several eye doctors in California had begun to notice vision problems in their patients who were being treated with Elmiron. These opthamologists began combing through the medical records of their patients to examine the potential link between Elmiron and eye damage.

In 2019, these eye doctors published a study which showed that 25% of patients who had taken Elmiron at high doses had developed damage to their retinas. The study found that the risk of eye damage from Elmiron increased depending on the amount of the drug that was taken: only 11% of patients who took 500 to 1,000 grams of the drug had developed retinal damage, compared to 42% of the patients who had used 1,500 grams or more.

Elmiron Lawsuits Filed Against J&J, Janssen

Johnson & Johnson and Janssen Pharmaceuticals, the manufacturer of Elmiron, is facing several lawsuit filed by patients who developed pigmentary maculopathy, retinal damage, vision loss, blindness, or other side effects linked to the drug. Lawsuits have also been filed seeking class action status on behalf of patients who developed vision problems after taking Elmiron.

These lawsuits against Janssen and Johnson & Johnson allege that the drugmakers failed to properly warn patients with interstitial cystitis who were prescribed Elmiron about the risk they may face of retinal toxicity and other problems with their eyesight. According to one lawsuit filed in May 2020, the two drug companies were aware of evidence that Elmiron could cause vision loss, but failed to disclose this information to regulators or the public.

As of March 2021, at least 90 Elmiron lawsuits have been filed against Janssen and Johnson & Johnson. However, because it can take years after using Elmiron for vision problems caused by this drug to develop, legal experts predict that more lawsuits will continue to be filed by patients who developed eye damage in the years before researchers first warned about the side effects of this medication.

Contact a Lawyer for Your Free Legal Consultation

If you or a loved one used Elmiron to treat interstitial cystitis (also known as painful bladder syndrome) and have developed pigmentary maculopathy, eye damage, blindness, or other vision problems, you may be eligible to file a lawsuit. The first step in taking legal action is to speak with an experienced attorney who can advise you regarding your legal rights and guide you through the first steps in filing a claim.

For more information about filing an Elmiron lawsuit and to find out whether you may be eligible to take legal action, contact the lawyers at Hissey, Mulderig & Friend to schedule your free legal consultation. You can reach us by calling our toll-free hotline 24-7 at 1-866-806-8117, or by answering a few brief questions in our free case evaluation form located on the right side of this page.