What is the Elmiron lawsuit about?

February 23, 2022

Elmiron, a medication manufactured by Janssen Pharmaceuticals (a division of Johnson & Johnson), is currently the only medication available to treat interstitial cystitis (IC), more commonly known as painful bladder syndrome. Long term exposure to Elmiron has been linked to maculopathy, an eye disorder affecting the macula (central part of the retina) and characterized by a progressive loss of central vision. Pentosan polysulfate sodium (Elmiron) was approved in 1996 by the FDA as the only oral medication approved to treat bladder pain and discomfort associated with IC. This medication was prescribed to countless patients, mostly women, subjecting millions to the risk of serious eye damage. Elmiron does not cure IC but it can be used as a “Band-Aid” to alleviate pain associated with the disease; however, Elmiron may do more damage than good to IC patients. Initially, patients are prescribed Elmiron at a minimum dosage of 100mg, 3x daily for 6 months to see if it will alleviate their IC pain, with no guarantee that it will work. Starting as far back as 2018, studies began documenting visual problems in Elmiron users, and in 2019, data presented at the American Academy of Ophthalmology showed Elmiron use may be associated with an increased occurrence of macular damage that can lead to slow vision loss and ultimately, blindness. Despite these findings, the FDA issued NO change or warning labels for macular damage, visual changes, or other eye conditions on prescribing information for Elmiron. In June of 2020, Janssen placed a warning in its package and prescribing information concerning the potential for vision loss; however, prior to this recent amendment to the information, the drug manufacturers did not adequately disclose the link between Elmiron use and serious vision damage and failed to warn patients about this risk.

What do you need to do?

If you or a loved one have been prescribed Elmiron, have been taking the medication for 6 months or longer, and have experienced vision problems, you may be eligible for compensation. Researchers suggest that patients who have been prescribed Elmiron and have noticed visual changes should seek an ophthalmic examination with retinal imaging, under consultation from your ophthalmologist. The disorder that appears to affect Elmiron users is known as pigmentary maculopathy and may be rare or unique to Elmiron users. Pigmentary maculopathy often presents as a black circle in the middle of vision.

Elmiron has been linked to: