Interstitial cystitis is a common condition affecting between three and eight million women in the U.S., and between one and four million men. Characterized by pain, a sensation of heaviness, and urinary urgency, it can interfere significantly with one’s quality of life. Thus far, one of the few medications commonly prescribed for the condition was Elmiron, whose active ingredient is pentosan polysulfate sodium. Recent research has found that Elmiron is linked to vision loss, with some patients experiencing pigmentary maculopathy and other vision complications.
Legal Ramifications
Currently, lawsuits are being filed across the U.S. with plaintiffs alleging that the drug’s manufacturers (Janssen Pharmaceuticals, under Johnson & Johnson) were aware that the drug was tied in to vision loss since 2018 yet failed to warn patients of the risk of vision loss. In some states, individual lawsuits have been brought as well as Elmiron class action suits, in which various plaintiffs make similar allegations. The plaintiffs claim that the manufacturers had received multiple AERs (adverse event reports) from health professionals about the effects of Elmiron. They add that the manufacturers “knowingly withheld and/or misrepresented information required to be submitted under FDA NDA regulations about the safety and effectiveness of Elmiron.”
What Vision Problems Are Linked To Elmiron?
Just a few vision problems linked to Elmiron include having problems in one’s field of vision, difficulties with reading and seeing close objects, dimming of omission, and having problems adjusting to low or dark lighting. These can be attributed to pigmentary maculopathy, which involves the back part of the retina. The retina is responsible for sensing light and sending signals to the brain, enabling vision. Maculopathy is the most common cause of vision loss in the Western world.
Can Pigmentary Maculopathy Be Stopped?
When this condition is caused early and the medication is stopped, damage can be stopped. However, when this medication has been taken for many years, vision loss can be permanent. It was in May 2018 that W Pearce at al from the Emory Eye Center published research showing that six patients who had taken pentosan polysulfate sodium for interstitial cystitis had pigmentary maculopathy. Subsequent research showing similar results was published in 2019 and 2020. The severity of damage was linked to dosage. That is, persons who took over 1,500g had the highest toxicity rates. Currently, around 25% of people who take Elmiron for over half a year may show ocular damage because of drug toxicity.
Lawsuits, both individual and class action, are currently being brought against Janssen Pharmaceuticals for the medication, Elmiron. The latter has been linked in various studies to vision loss, caused by pigmentary maculopathy. The latter is a condition affecting the back part of the retina. If you have been taking Elmiron and you have difficulty adjusting to the dark, reading problems, or issues viewing items which are close, seeing both your doctor and legal professional may be advised. If you have been taking the medication for many years, the vision problems may be permanent and may interfere with your quality of life or your ability to do your job.
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