With many long-trusted drugs now coming under scrutiny for very undesirable side-effects, another level of frustration is added when you take a drug for one thing, and it causes an issue that seems completely unrelated.
Such is the case in the arising Elmiron lawsuit that alleges eye problems, such as maculopathy, may result from taking Elmiron.
If you have experienced deteriorating eyesight and you take Elmiron, there may be a connection between the two. This article will help you get a deeper understanding of that connection and the current lawsuits.
What is Elmiron Used For?
Elmiron is a medication prescribed to women that is meant to ease pain and discomfort for interstitial cystitis, a type of bladder problem.
The active ingredient in Elmiron is pentosan polysulfate sodium (PPS), which is the source of a lot of the issues arising in the lawsuit.
PPS works by creating a layer on the bladder wall to protect it from harmful and irritating substances that may be in your body’s urine.
The drug was first submitted to the FDA in June of 1991 and was granted its first approval for consumption on September 26, 1996. This means that the drug has been on the market for over 2 decades.
Elmiron is currently manufactured by Janssen Pharmaceuticals, which today simply goes by the name Janssen. They are part of the Johnson & Johnson family of companies.
It may seem odd that a drug meant to create relief from bladder pain would cause something seemingly unrelated like blindness, but more and more data is arising to show the connection.
Unexpected Side Effects of Elmiron
Labels on drugs are required to list out their side effects.
The label on Elmiron lists the common side effects like diarrhea, hair loss, blood in the stool, rash, headache, upset stomach, abnormal liver function tests, bruising, and dizziness.
Prior to June of 2020, it stated nowhere on the label that it may cause the development of pigmentary maculopathy. In June, the label was changed to include a warning for possible “retinal pigmentary changes.”
The side effects may start with less severe vision problems such as difficulty reading and seeing objects up close but may scale up to severe problems like blindness.
The fact that Janssen hadn’t even added maculopathy as a possible side effect to the label for the first 24 years to cover themselves legally goes to show how far out of left field this diagnosis seems to come, given the fact that Elmiron is meant to treat irritation in your bladder.
The Research Behind Elmiron and Blindness
There are several studies that point to the connection between taking Elmiron and developing pigmentary maculopathy.
In 2015 and 2017, a group of researchers were studying Elmiron and found that many of the patients had developed an eye disorder. The study described the occurrence as “novel,” and that the symptoms were indicative of early Retinal Pigment Epithelium (RPE) injuries.
Further research in 2019 showed that long-time and recurring use of PPS (such as that found in Elmiron) cause structural changes in the eye that show themselves as pigmentary changes.
Misdiagnosis and Elmiron Issues
Given that the diagnosis of pigmentary maculopathy is defined as “novel” by researchers, it’s safe to assume that optometrists likely won’t know that the root cause of eye issues you may have are linked with taking Elmiron. However, an ophthalmologist who specializes in diseases of the eye, may be able to link the root cause of your disorder.
It’s hard to ask your eye doctor if your maculopathy is related to taking Elmiron, because it’s a bladder medication and the connection seems to be unrelated.
If you have had a diagnosis of a degenerative eye disorder and you do take Elmiron, it’s a good idea to contact a personal injury attorney for a free consultation.
Is the Elmiron Lawsuit a Class Action or MDL?
The Elmiron litigation is still in the very early stages as more information is gathered on the alleged link between the drug and blindness.
In December of 2020, 130 lawsuits were transferred to New Jersey to be overseen in a multi-district litigation (MDL) by U.S. District Judge Brian Martinotti.
The lawsuits are directed at Janssen Pharmaceuticals for the eye problems allegedly caused by their drug Elmiron.
While the label now contains a side effect warning for “retinal pigmentary changes,” the label was missing this warning prior to June 2020.
Elmiron isn’t a class action lawsuit because the current lawsuits involve possible major damages being awarded to the plaintiffs.
Class actions usually occur when a large number of people were affected, but the damages don’t individually merit a lawsuit.
Elmiron has been consolidated into an MDL so that a few bellwether cases can be tried, and then the ruling from those cases can be applied to the larger swath of cases in the litigation.
Is Elmiron Still Available?
Elmiron (pentosan polysulfate sodium) capsules have not been recalled by the FDA since the drug was approved in 1996.
This stands even in light of more recent studies showing the alleged connection between Elmiron and pigmentary maculopathy.
The drug is still available as a prescription for over 1 million people in the United States that have interstitial cystitis.
There are currently no dates set for an Elmiron recall as more research is being done, and lawsuits are in the very early stages of litigation.
Do You Qualify For An Elmiron Lawsuit?
If you have taken the drug Elmiron for interstitial cystitis, and have a diagnosis of a deteriorating eye condition, it may be a good time to call a personal injury attorney.
VanDerGinst Law has decades of experience in helping victims of dangerous drugs and has recovered hundreds of millions of dollars on behalf of our injury clients.
We invite you to call us for a free consultation to see if you qualify for an Elmiron lawsuit.
You will never owe us anything out of pocket.
Reach out to us today at 800-797-5391, or contact us online.
We would be honored to help.