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A Tennessee woman has filed a new Elmiron lawsuit in the U.S. District Court for the District of New Jersey. All federally filed Elmiron lawsuits were consolidated in that court in December 2020. The woman claims that after she used Elmiron (pentosan polysulfate sodium or PPS), she suffered from serious injuries.

Plaintiff Suffers Maculopathy After Taking Elmiron for Nearly 20 Years

According to her complaint, the plaintiff was diagnosed with interstitial cystitis (IC), which is a chronic condition that can cause bladder pressure and pain; a persistent, urgent need to urinate; frequent urination; painful sexual intercourse; and pain or discomfort when the bladder fills followed by relief after urinating.

To treat her condition, the plaintiff’s physician prescribed Elmiron in 2001. Elmiron is the only prescription medication approved by the Food and Drug Administration (FDA) to treat IC. Though it does not cure the disease, it can help to relieve symptoms and improve quality of life.

The plaintiff took Elmiron from 2001 to 2020 and now suffers from severe maculopathy in both eyes. Maculopathy is a progressive disease that can lead to vision loss. Her symptoms include blurry vision, night blindness, difficulty adjusting to dim light, dark/blank spots in her field of vision, near vision problems, and straight lines appearing curved or squiggly.

She blames her vision problems on her intake of Elmiron and the fact that the manufacturers failed to warn her or her doctor about the potential risk for vision loss associated with the medication.

Early Evidence Shows Association Between Elmiron and Vision Problems

Elmiron came onto the market in 1996. Manufacturers first applied for FDA approval in 1991, five years earlier, but the FDA delayed a couple of times based on a lack of evidence of efficacy before finally approving in 1996.

The drug did not contain any warnings about vision damage, however, even though there was early evidence that its use was associated with maculopathy and other retinal disorders. The plaintiff refers to the manufacturer’s own new drug application, which included reports of adverse effects including blurred vision.

Almost immediately after the FDA approved the drug, patients and doctors began to report serious complications relating to eye and vision problems in patients taking Elmiron. Nearly 150 cases of eye disorders as adverse effects of Elmiron were reported to the FDA in 1997, including blurred vision, maculopathy, blindness, and halo vision.

Yet the defendants failed to provide users or doctors with any warnings of vision problems.

Manufacturer Waits Until 2020 to Warn About Elmiron Vision Damage

In the spring of 2018, Dr. Neiraj Jain and colleagues wrote a letter to the editor of the Journal of Urology alerting readers to a new condition they were seeing among their patients taking Elmiron. Specifically, they had observed unhealthy vision changes in six patients who had been using Elmiron for several years.

Other scientists made similar observations, and over the next couple of years, several studies were published linking Elmiron to vision problems. Scientists at Kaiser Permanente found that of the 140 of their patients who had taken Elmiron for a minimum of 5 years, 22 (24 percent) showed eye damage. The greater the quantity of Elmiron taken, the greater the damage.

Janssen Pharmaceuticals, the current manufacturer of Elmiron, finally changed the label for Elmiron products sold in the U.S. in 2020, warning patients and doctors that maculopathy had been identified with both short- and long-term use of the drug. The FDA approved the changes on June 16, 2020.

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