Elmiron (pentosan polysulfate sodium) is a blood thinner that was approved by the FDA in 1996 for the treatment of painful bladder syndrome (interstitial cystitis). In recent years, this drug has been prescribed, off-label, for use in the treatment of orthopedic conditions.What are the Problems Associated with Elmiron?
Elmiron has been linked to cases of eye damage and vision-related injuries. A study published by the National Library of Medicine showed a link between Elmiron and pigmentary maculopathy. This disease entails pigmentary changes to the macula, which is the center part of the retina. The retina is the light sensitive inner lining at the back of the eyeball. The study is: Pearce, William A, et al. (2019, July 7) Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium, Ophthalmology.
The symptoms of Pigmentary Maculopathy mimic the symptoms of Macular Degeneration. If you have been diagnosed with Macular Degeneration, you may have Pigmentary Maculopathy.What are the Symptoms Associated With Elmiron Eye Problems?
- Dimmed or less vivid vision, especially associated with colors
- Difficulty seeing at night or in low lighting
- Floaters (spots) in the field of vision, especially in the center
- Distorted vision, such as seeing straight lines as squiggly or wavy
- Blurred vision
- Difficulty reading
- Slow adjustment to low or reduced light environments
There are three tests that eye specialists use to assess damage to this part of the eye.
- Ocular coherence tomography (OCT)
- Color fundoscopic photography
- Auto-fluorescence imaging
It is extremely important to your eyesight to undergo testing if you have been taking Elmiron.What can be Done Legally if I Have Eye Damage?
Elmiron is manufactured by Jannsen Pharmaceuticals, which is a subsidiary of Johnson & Johnson. Johnson & Johnson has been in the news frequently in the past several years. Notably, in connection with the opioid crisis, Johnson & Johnson has been accused by governmental entities and individuals of using deceptive practices to market billions of dollars of opioids. In August 2019 Johnson & Johnson was ordered to pay the State of Oklahoma $572 million.
Johnson & Johnson has also been accused of selling a contaminated product, Johnson’s Baby Powder®. Plaintiffs in the Johnson & Johnson talcum powder suits assert that Johnson and Johnson sold Baby Powder® to unsuspecting consumers despite having knowledge that the talcum powder had asbestos contamination. There are currently more than 18,000 talc cases pending against Johnson & Johnson wherein people have alleged their cancer was caused by talcum powder use. As you can see, Johnson & Johnson is no stranger to controversy surrounding their marketing practices and products. Johnson & Johnson continues to deny any wrongdoing in connection to both of these matters.
Manufacturers have a duty to create safe products that do not injure consumers. They also have a duty to warn about dangers associated with their products. Prior to June 2020 there were no warnings on the Elmiron label related to potential eye damage. The FDA has now approved changes to Elmiron’s label, which includes warnings for patients who take Elmiron. These warnings contain information about retinal pigment changes and appropriate evaluation and treatment.
In May 2020, the first Elmiron lawsuit was filed against Jannsen Pharmaceuticals. The litigant in that suit is claiming eye damage related to many years of Elmiron use. The litigant asserts that Jannsen is responsible for creating a dangerous drug and for failing to warn consumers about these dangers. Additional cases have followed. Since the cases are relatively new, they are still in the information gathering stage. However, medical articles supporting the causal connection between Elmiron and eye damage continue to be published. As people are learning about the connection between Elmiron and eye damage, they are seeking the advice of attorneys, including Robin Lourie.
Additional medical articles include:
American Academy of Ophthalmology (2019, October 12) More Evidence Linking Common Bladder Medication to a Vision-Threatening Eye Condition, Science Daily. As reported in this article.
Huckfelt, Rachel M, and Vavvas, Demetrios G. (2019, November 6) Progressive Maculopathy After Discontinuation of Pentosan Polysulfate Sodium, Ophthalmic Surgery, Lasers and Imaging Retina. As reported in this article.
Dorian, R. Christopher, et al. (2020, January 7) Possible Drug-Induced, Vision-Threatening Maculopathy Secondary to Chronic Pentosan Polysulfate Sodium (Elmiron®) Exposure, Canadian Urological Association Journal. As reported in this article.What is My Next Step?
Undoubtedly, many Elmiron lawsuits will be filed in the coming months. If you are interested in obtaining a free evaluation by Robin Lourie Law to see if you have a case against Elmiron, please contact us here. We will be happy to speak to you about a potential claim.