Janssen Pharmaceuticals is facing yet another Elmiron lawsuit, as a new plaintiff blames the bladder pain drug for causing the limited loss of her vision.
According to a complaint filed in the U.S. District Court, Eastern District of Pennsylvania, on May 4th, Barbara English, a resident of South Carolina, was prescribed Elmiron to treat interstitial cystitis in 2001 and began experiencing visual symptoms some time in 2017. On April 11, 2019, English was diagnosed with permanent retinal injury and vision loss associated with Elmiron use. (Case 2:20-cv-02150)
The lawsuit cites a long list of studies and reports linking Elmiron to retinal and macular toxicity. Yet Janssen has never updated the Elmiron label in the United States or take other steps to warn doctors and patients about these possible side effects, despite doing so in Canada and certain other countries.
“Defendants ignored reports from patients and health care providers throughout the United States of Elmiron’s failure to perform as intended, and injuries associated with long term use which led to the severe and debilitating injuries suffered by Plaintiff, and numerous other patients,” the lawsuit states. “Rather than doing adequate testing to determine the cause of these injuries or rule out Elmiron’s design as the cause of the injuries, Defendants continued to market Elmiron as a safe and effective prescription drug for interstitial cystitis.”
Elmiron (pentosan polysulfate sodium) is the only drug approved by the U.S. Food & Drug Administration (FDA) to relieve bladder pain and discomfort associated with interstitial cystitis. Since coming to market in 1996, however, the FDA’s Adverse Event Reporting System has received at least 100 reports of eye disorders related to the use of Elmiron, including 8 cases considered serious and 22 that mentioned various forms of maculopathy.
Most recently, a case study published in Ophthalmic Surgery, Lasers and Imaging Retina last November suggested that Elmiron-induced maculopathy might even continue long after treatment ended. Many experts are now recommending that all Elmiron patients undergo ophthalmic examinations for early detection of maculopathy and other eye disorders, particularly long-term users.