Patients who were prescribed Elmiron (pentosan polysulfate sodium) to treat their interstitial cystitis (IC) may have another health problem to worry about after it was revealed that the medication is associated with vision-threatening retina damage.
The link between Elmiron and an eye disease called pigmentary maculopathy was first reported more than two decades after the drug gained FDA approval. Elmiron warning labels were updated to warn of this risk in 2020, but not before the drug was prescribed to large numbers of IC patients. Many of these patients took the drug for years, unaware that it could be causing irreversible vision loss. They are now fighting back against Janssen Pharmaceuticals and filing Elmiron lawsuits.
Morgan & Morgan is leading the way in holding Janssen accountable. Read on to learn critical information about Elmiron eye disease lawsuits, and contact us to speak with an attorney.
The Elmiron-Maculopathy Link
Maculopathy is an eye disease that affects the macula—a small but important part of the retina at the back of the eye that lets us clearly see details of objects in front of us. Elmiron was first linked to maculopathy in a small 2018 study. Researchers called the disease a “novel” maculopathy because it was different from other known retinal diseases. They were puzzled by the cause of the patients’ symptoms but noticed a common factor: all were taking Elmiron for IC treatment.
This observation led to further investigation that has strengthened the Elmiron-maculopathy link. Subsequent scientific articles confirming the link have appeared in publications that include the British Journal of Ophthalmology, Ophthalmology, and the Canadian Journal of Ophthalmology. These studies have found that about 20 – 25 percent of long-term Elmiron users develop significant retina damage.
Video: Elmiron Lawsuits Explained
FDA Updates Elmiron Warning Labels
In spring 2018, the researchers that first discovered the link between Elmiron and vision problems wrote a letter to the editor of the Journal of Urology alerting readers about what they’d observed. This was the first report of Elmiron's vision loss. Two years later, in June 2020, the FDA approved a new Elmiron drug label that warns about pigmentary changes in the retina identified with long-term drug use.
As Retina Today notes in a 2020 article, PPS has been prescribed to “hundreds of thousands of patients with IC,” since the drug was first approved in 1996. Before then, it was available on a compassionate use basis starting in 1986. In other words, Elmiron was available to IC patients for 24 years—and in some cases 34 years—without any warnings about possible retina damage. Retina Today adds that “It is unusual for a potential drug toxicity to manifest decades after initial FDA approval. PPS safety was not a major issue in clinical trials, and no ocular adverse events were identified.”
Janssen’s Knowledge of Elmiron Vision Problems
Since Janssen did not warn until 2020 that taking Elmiron can damage the retina, it begs the question of what they knew about this side effect—and when they knew it.
The FDA states that retinal changes identified with long-term Elmiron treatment tend to occur after 3 years of use or longer. This delayed onset of symptoms may explain why the side effect did not show up in clinical trials, which are typically much shorter in duration. But it does not let Janssen off the hook.
In lawsuits, plaintiffs claim that since 1997 (a year after Elmiron gained FDA approval), Janssen received Adverse Event Reports (AERs) from medical professionals, both in the United States and Europe, about Elmiron. These events included retinal hemorrhage, macular degeneration, and blindness, according to lawsuits.
If these reports are true, then Janssen had knowledge of Elmiron vision problems for years but did not issue warnings. Regardless, a strong case can still be made that Janssen, in the exercise of reasonable care, should have known that Elmiron can cause eye injuries. Drugmakers generally cannot plead ignorance as a defense to negligence claims.
Qualifying for an Elmiron Lawsuit
Doctors had no way of knowing about Elmiron and vision changes prior to June 2020, when the new warning label was issued. It was ophthalmologists that first observed maculopathy in Elmiron users. The spring 2018 letter in the Journal of Urology was probably the first time that prescribing doctors, such as urologists and gynecologists, received any information about this previously unknown side effect.
Many doctors would not have prescribed Elmiron had they known about the link to retina damage. And many patients would have chosen not to take it. Neither doctors nor the FDA, bear the blame for the lack of warnings. If anyone is at fault, it’s the drugmaker, Janssen.
You may be able to file an Elmiron lawsuit against Janssen if you were prescribed the drug and have been diagnosed with maculopathy or vision damage. If you take Elmiron but have not yet received a maculopathy diagnosis, you may want to schedule an appointment with your eye doctor, who can perform retinal imaging tests. Symptoms of Elmiron-related maculopathy include:
- Difficulty reading
- Trouble adapting to darker conditions
- Muted, less vivid colors
- Changes in the color of the retina
- Partial or total vision loss
- Difficulty with near vision
- Generalized dimming of vision
- Distorted vision where straight lines become wavy
Why You Can Trust Morgan & Morgan
As America’s largest personal injury law firm, we’re one of the only firms with the size, strength, and resources to take on Big Pharma—and win.
In fact, the court overseeing Elmiron lawsuits nationwide recognized the ability and experience of our attorneys when it appointed Morgan & Morgan’s Paul Pennock Co-Lead Counsel in the litigation. Our firm, and Paul, have a proven track record of successfully resolving major pharmaceutical lawsuits. Over the last 30 years, we’ve recovered more than $10 billion for our clients, including large verdicts and settlements from the world’s biggest drug companies.
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