Doctors and researchers have recently discovered a troubling fact: Elmiron leads to eye problems in patients exposed to the drug over time. Long thought to be safe for the ongoing treatment of bladder conditions, millions of patients have relied on Elmiron for years at a time. In fact, Elmiron eye problems include permanent damage to the retina, vision problems and blindness.
Critics say the drugmaker, Johnson & Johnson, knew or should have known of the risk for Elmiron eye problems, yet failed to warn the public. Attorneys handling Elmiron eye problems lawsuits believe persons and the family members of persons who have suffered from Elmiron eye problems may be eligible for compensation. This page provides a comprehensive look at Elmiron eye damage.
Elmiron (pentosan polysulfate sodium) was approved by the FDA in 1996. Since that time, it has remained the only approved treatment for interstitial cystitis, a bladder condition that affects more than a million Americans--most of them women.
Interstitial cystitis, or IC, is characterized by chronic pain in the pelvic area and bladder. Treatment involves long term dependence on Elmiron, a drug previously believed to be safe for extended use. Researchers believe Elmiron resolves the symptoms of IC by forming a protective layer on the wall of the bladder.
Elmiron is marketed by Janssen Pharmaceuticals, a division of Johnson & Johnson. The drug's patent expired in 2010, yet no generic alternatives have been developed. Janssen has increased the price for Elmiron periodically, and patients who rely on it pay approximately $600 monthly to keep bladder pain at bay. Elmiron brings J&J approximately $150 million in annual sales.
Elmiron eye damage is a risk faced by anyone taking the drug, though it is known that eye problems from Elmiron typically develop after a significant exposure to the drug. Long believed to be safe, we now know Elmiron poses a risk for pigmentary maculopathy and macular degeneration.
Symptoms of Elmiron eye damage include:
Elmiron eye problems result from the substance's toxicity to the retina, according to researchers. The tissue at the back of the eye that senses light, the retina is vital to seeing. Over time, exposure causes structural changes to the pigmented (colored) layer of the retina, resulting in Elmiron eye problems.
It is known that the risk for Elmiron eye damages increases over time, but it is not yet known how much of the drug is too much. Medical providers are now urged to monitor annually for early signs of retina damage from Elmiron. Experts believe stopping the use of the drug can halt further Elmiron eye damage, yet there is no alternative treatment for the bladder condition, IC.
Researchers believe hundreds of thousands of Americans may have suffered from mis-diagnosed Elmiron eye problems for decades. The link between Elmiron and eye damage was only discovered in 2019, when the first Elmiron eye problems study confirmed the hunch of a clinician.
Nieraj Jain, M.D., of Emory Eye Center in Atlanta, Georgia, raised a red flag when he noticed a worrisome trend: Six of his patients had developed structural changes to the macula, creating a range of vision problems, and each of these patients was taking Elmiron. This was the first indication of Elmiron eye damage.
As a result of Dr. Jain's warning, a team of ophthalmologists in the Kaiser Permanente network conducted a comprehensive analysis of their system's 4.3 million patients. Among these, they closely examined patients who had taken Elmiron for at least five years. The results showed a clear connection between Elmiron and eye damage: 24% of patients develop eye damage from Elmiron over the long term. The researchers determined that as exposure to Elmiron increases, the rate of drug toxicity and retinal damage also rises.
"It's unfortunate," said Dr. Robin A. Vora, M.D of Kaiser Permanente. "You have a patient with a chronic condition like interstitial cystitis, for which there is no cure and no effective treatment. They get put on these medications because it's thought to have few side effects and few risks, and no one thinks about it again. And year after year, the number of pills they're taking goes up and up."
Patients taking Elmiron were never warned of the potential for severe and permanent Elmiron eye damage. What is more, many of these cases were misdiagnosed as age-related macular degeneration or pattern dystrophy--meaning the patients continued to take the toxic drug Elmiron, potentially resulting in ongoing Elmiron eye damage.
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