The manufacturers of Elmiron (pentosan polysulfate sodium) are facing yet another lawsuit, this time a class action complaint that seeks medical monitoring on behalf of consumers allegedly at risk for retinal damage and vision loss.
Elmiron is the only drug cleared by the U.S. Food & Drug Administration (FDA) to relieve bladder pain and discomfort associated with interstitial cystitis. However, since approving the drug in 1996, the agency has received at least 100 reports of eye disorders affecting Elmiron users, including 8 cases considered serious and 22 that mentioned various forms of maculopathy.
In recent years, a growing number of case reports and studies have also linked Elmiron to pigmentary maculopathy and other forms of retinal damage that can result in permanent vision loss. While information about pigmentary maculopathy was added to the Elmiron label in Canada last October, the drug’s U.S. label continues to omit any mention of retinal injury.
According to the Elmiron class action lawsuit filed in the U.S. District Court, Eastern District of Pennsylvania, on May 6th, the lead plaintiff was prescribed the medication for interstitial cystitis in 2009. She claims she and other member of the proposed class are more likely to suffer severe visual injuries, including vision loss, retinal macular dystrophy, pigmentary maculopathy and atypical macular degeneration, due to their long-term use of Elmiron. (Case No. 2:20-cv-02183)
“Throughout the time Defendants marketed Elmiron, Defendants withheld material adverse events from the public, medical community, and the FDA. Defendants failed to disclose the serious link between Elmiron use and significant visual damage, including pigmentary maculopathy,” the complaint states. “Ultimately, tens of thousands of patients, including Plaintiff, were placed at risk and harmed as a result of this misleading conduct.”
The Elmiron lawsuit also notes that may patients experiencing retinal damage remain asymptomatic prior to the manifestation of significant injuries. For that reason, the plaintiff is demanding that Johnson & Johnson and its Janssen Pharmaceuticals subsidiary establish a medical monitoring protocol for all class members consisting of:
“The relief Plaintiff seeks on her own behalf and on behalf of the Class is reasonable and consistent with the FDA’s approved labeling on other drugs associated with retinal damage,” the complaint asserts. “Those labels . . . generally require patients receive regular eye exams to monitor for signs of retinal damage and that they should cease use of the drug at the first sign of damage.”