Elmiron – the recognizable brand name for pentosan polysulfate sodium (PPS) – is the leading pharmaceutical choice to treat painful bladder syndrome or interstitial cystitis. It is also suspected to be a new source of eye damage and vision loss among its users.
Janssen Pharmaceuticals and Johnson & Johnson (J&J) are facing scrutiny and lawsuits by Elmiron users who want answers and fair compensation. According to the complaints from affected users, there were no adequate warnings that extended Elmiron use could cause vision loss or total blindness. The drug’s packaging even went as far as to say that there were no warnings that needed to be outlined there.
The Big Pharma companies are believed to collect more than $150 million in revenue from Elmiron sales each year, and the drug has been popular for at least the last 10 years. It is only fair to assume that the companies can afford to fairly compensate Elmiron users. But it is a question of if they will without putting up a legal fight.
What are Elmiron Side Effects?
The reported side effects of Elmiron use include:
- Heartburn
- Bruising
- Uncharacteristic mood swings
- Diarrhea
- Headaches
- Dizziness
- Hair loss
- And more
It was only after the first signs that Elmiron could cause eye damage with extended use did Janssen update the side effects list to include temporary eye complications like conjunctivitis. At no point did the Big Pharma corporation add blindness and other permanent eye conditions to the warning list, despite knowing that this could happen to users.
Only recently, Janssen added maculopathy to Elmiron’s risks after studies concluded that the drug could cause the eye condition. Maculopathy is caused by damage to the macula, which is the part of the retina that allows for keen facial recognition and sharp color distinction. When the macula is significantly damaged, it can cause complete vision loss. To date, it is believed that thousands and thousands of Elmiron users have experienced maculopathy to some degree.
What Studies Back Up the Complaints Against Elmiron?
The Emory Eye Center in Georgia first began to suspect that Elmiron could cause macula damage in 2015. Six patients who all had unusual macula damage not typical of most maculopathy cases were found to have all been longtime users of Elmiron. In 2017, the researchers first reported their suspicions that Elmiron could cause vision loss, a side effect previously not disclosed to the public.
A year later, researchers from the same institution expanded their case study to 10 more patients who had maculopathy and used Elmiron. Another 156 patients were studied who had painful bladder syndrome but did not use Elmiron to treat it. The study uncovered that none of those 156 patients had signs of macula damage, which was a stark contrast to 100% of the Elmiron users developing this eye condition.
Not long after the Emory Eye Center released its expanded findings, studies from Kaiser Permanente, the British Journal of Opthalmology, and the American Academy of Ophthalmology (AAO) all backed up the findings. In fact, the AAO researchers concluded that a shocking 25% of Elmiron users would more than likely suffer from maculopathy, especially among users who were taking larger daily doses. Most recently, a 2020 study from the AAO used another 117 patients for further research and still reached the same conclusion: Elmiron causes blindness or permanent vision problems.
“Failure to Warn” Lawsuits Against Janssen
Dangerous drug lawsuits filed against Janssen primarily accuse the Big Pharma company of failing to warn users about the full extent of Elmiron’s potential side effects. Many have claimed that Janssen and J&J did not know to warn people about vision loss caused by Elmiron because the companies did not dedicate an adequate amount of time to researching the drug and its side effects before sending it to the market. Janssen even admitted after lawsuits began to form that most of the drug did not get absorbed into the bladder where it can alleviate painful bladder syndrome symptoms. Instead, the drug is dispersed throughout the bloodstream, where it seems to eventually collect in the macula, causing permanent damage.
Side effects commonly named among Elmiron lawsuits include:
- Maculopathy
- Blurry vision
- Poor vision at night
- Total blindness
- Inability to read without pain
- Haloed lights
If you have used Elmiron and are now experiencing these side effects and more, then it is time to discover your legal options. You might be able to bring a lawsuit against Janssen and J&J for selling an unsafe and largely untested drug. Even if Elmiron did help treat your painful bladder syndrome, you can still demand compensation if you’ve suffered from vision loss or maculopathy after using the drug.
Golomb Legalis currently hearing from Elmiron users throughout Pennsylvania and across the country. We are recognized as a premier class action law firm with a national reach and a history of success. To date, we have recovered more than $2 billion in verdicts and settlements for our clients, who have filed individual lawsuits and joined class actions alike. If there is one team of Elmiron attorneys you can trust to go head-to-head with Big Pharma for you, it’s us.
Find out if you should be filing an Elmiron lawsuit or joining a class action by calling (215) 278-4449 today. Free consultations are available to inquiring clients. We accept calls from people nationwide, so don’t hesitate to reach out to us, no matter where you call home.