Elmiron Makers Failed to Disclose Vision Risks to Users, Medical Community, Lawsuit Alleges

Johnson & Johnson and its Janssen Pharmaceuticals unit face yet another Elmiron lawsuit accusing the drug makers of actively withholding from consumers and the medical community critical information about the serious and potentially irreversible vision risks that have been linked to Elmiron treatment. This latest Elmiron lawsuit was filed by a California woman who suffered permanent retinal damage and other life-altering complications allegedly caused by the popular interstitial cystitis medication. If you or someone you know has experienced vision loss, retinal maculopathy, or any other vision problem during or after Elmiron use, contact us today to learn about your options for legal recourse. You may be eligible to file an Elmiron vision loss claim against Johnson & Johnson and Janssen Pharmaceuticals, in order to pursue the financial compensation you deserve for your injuries.

Elmiron for Interstitial Cystitis Treatment

Elmiron, also known as pentosan polysulfate, is a prescription medication used to treat a chronic bladder condition called interstitial cystitis (IC). People with IC typically experience symptoms like bladder pain or pressure, a frequent urge to urinate, and sometimes pelvic pain that can range from mild to severe. Elmiron can help manage the symptoms of interstitial cystitis, which can be uncomfortable, painful, and incapacitating. Unfortunately, relapse is likely to occur if Elmiron treatment is discontinued, which means people with IC generally take the drug long-term. Elmiron was approved by the U.S. Food and Drug Administration (FDA) in 1996 and it remains the only oral medication approved to treat bladder pain and discomfort associated with interstitial cystitis. It is estimated that hundreds of thousands of people have taken Elmiron since it entered the market in the United States.

Retinal Maculopathy in Elmiron Users

Until recently, the side effects of Elmiron treatment were believed to be minor, ranging from nausea and upset stomach to possible hair loss. However, new reports indicate that people taking Elmiron may also be at risk for retinal maculopathy, a progressive eye disease that can lead to permanent vision loss, as well as other irreversible vision problems. A growing number of independent studies and published case reports have identified instances where long-term Elmiron users have reported retinal pigmentary changes resulting in symptoms like blurred vision, problems with reading and difficulty adjusting to dim lighting, among others.

New Pigmentary Maculopathy Warnings Added to Elmiron Label

In June 2020, the FDA finally approved a new warning label for Elmiron, indicating that “pigmentary changes in the retina,” known as pigmentary maculopathy, can occur in people who take Elmiron long-term and that these changes may persist even after treatment is discontinued. “Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use,” the new Elmiron warning states. It goes on to say that “While the etiology is unclear, cumulative dose appears to be a risk factor.”

Accurate warnings about possible drug side effects are meant to educate patients and doctors and help them make informed decisions about what treatments are appropriate based on the potential risks and benefits. Unfortunately, because Elmiron was marketed as a safe and effective IC treatment for more than 20 years with no warnings about the potential for the drug to have a toxic effect on the retina, patients with interstitial cystitis continued taking Elmiron for years and may now be at increased risk for retinal maculopathy or pigmentary maculopathy.

Elmiron Vision Loss Lawsuits Brought Against J&J, Janssen

The medical community, too, was left in the dark regarding the potential adverse effects of Elmiron on the retina, and many doctors therefore kept patients on the medication, unaware that it was causing users to experience a wide range of vision problems. Now a growing number of former Elmiron users are pursuing legal claims against Johnson & Johnson and its Janssen Pharmaceuticals subsidiary, accusing the drug makers of actively concealing information about the serious vision risks they could face as a result of taking Elmiron.

In this latest Elmiron lawsuit, plaintiff Natalie Baum alleges that she suffered permanent retinal damage, vision loss and other problems caused by the controversial interstitial cystitis drug, which she began taking in 2005. Baum seeks to hold Johnson & Johnson and Janssen Pharmaceuticals liable for their alleged failure to inform her and her doctors about the possible side effects of Elmiron and the importance of Elmiron users undergoing regular vision testing during treatment. “The injuries and damages sustained by Plaintiff were caused by Defendants’ Elmiron,” Baum’s claim states. “Plaintiff may continue to suffer a progression of retinal and vision changes even though Plaintiff is no longer taking Elmiron.”