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According to allegations raised in a recently filed lawsuit, Elmiron side effects caused a Texas woman to go blind and experience complications that were initially misdiagnosed as part of the genetic disorder pigmentary retinary dystrophy, but which actually involved chorioretinal degeneration resulting from years of exposure to the painful bladder drug.
The complaint (PDF) was filed by Shari Lewis in the U.S. District Court for the Eastern District of Pennsylvania on November 24, indicating that Janssen Pharmaceuticals, Inc. failed to adequately to warn users and the medical community about the vision risks associated with their treatment for interstitial cystitis.
Elmiron (pentosan polysulfate sodium or PPS) was introduced in 1996, and is often taken for years, if not decades, since there is no known cure of the bladder and pelvis pain associated with interstitial cystitis.
Although the drug has been on the market for decades, no warnings were provided about the toxic effect Elmiron may have on the retina until earlier this year, leaving many doctors unaware that the medication may be the cause of blindness and vision problems experienced by long-term users.
It was only after a series of independent case reports and studies were published about the link between Elmiron and pigmentary maculopathy that the drug maker announced a warning label update in June 2020, which now advises users, urologists and opthalmologists that Elmiron may cause pigmentary changes in the retina, which can cause difficulty adjusting in dark light, trouble reading, centralized dark spots and complete blindness.
According to the lawsuit, Lewis began taking Elmiron in August 1997, and continued to use the medication until earlier this year. However, as early as 1999 she began to suffer vision problems, and she was diagnosed with pigmentary maculopathy in both eyes in 2002. After her vision continued to deteriorate, Lewis was declared legally blind in 2010
In 2013, Lewis was diagnosed with pigmentary retinal dystrophy, which is a genetic disorder which causes deterioration of vision, starting with night blindness and loss of side vision, and continuing until entire blindness results. However, at that time Elmiron had not been linked to vision problems and it was not until October 2020 that a retina specialist noted pigment epithelium changes and retina atrophy, leading to a diagnosis of chorioretinal degeneration caused by Elmiron.
“Throughout the time Defendant marketed Elmiron, Defendant withheld material adverse events from the public, medical community and FDA. Defendant failed to disclose the serious link between Elmiron use and significant visual damage, including pigmentary maculopathy,” the lawsuit states. “Ultimately, tens of thousands of patients, including Plaintiff, were placed at risk and harmed as a result of this misleading conduct.”
Since most ophthalmologists were previously unaware of the vision risks associated with Elmiron, many users were misdiagnosed with other forms of retinal disease and continued to be exposed to the medication, further worsening the damage.
Lewis’s claim joins a growing number of Elmiron lawsuits now being pursued throughout the U.S. court system. However, as lawyers continue to review and file claims in the coming months and years, it is expected that hundreds, if not thousands, of similar complaints may be brought in state and federal courts nationwide.