Elmiron is a drug used to treat interstitial cystitis. Most of you don’t know what interstitial cystitis is, and that’s a good thing. Unless you are a urologist, you wouldn’t have reason to know about the condition . . . unless you suffer from it. But if you suffer from interstitial cystitis, you probably know a lot about it. In this post I am going to describe the condition, then discuss Elmiron, the only FDA-approved drug to treat the condition, and finally highlight the latest studies indicating that Elmiron may cause pigmentary maculopathy, which can cause vision loss or even blindness.

Interstitial Cystitis

Interstitial cystitis is a painful bladder condition. Interstitial means situated within but not restricted to one organ or tissue, especially fibrous tissue. Cystitis means an inflammation of the urinary bladder. Urinary tract infection is one example of cystitis. Interstitial cystitis causes the walls of the bladder to become irritated or inflamed. This leads to bladder pressure, bladder pain, and pelvic pain. Interstitial cystitis is one of several conditions labelled painful bladder syndrome.

When your bladder is full (and working properly) it sends a signal through the pelvic nerves to your brain to let you know that you need to urinate. When you suffer from interstitial cystitis, these signals don’t work properly, and several symptoms may result, including:

• The sensation that you need to urinate more often;
• Frequent trips to the bathroom to urinate (often small amounts per visit);
• Pain in the bladder, pelvis, or abdomen;
• Frequent urinary tract infections (UTIs);
• Pain during intercourse;
• Pain near the perineum (near the anus);
• Abdominal pressure and bloating;
• Menstrual cramps.

A few factors that may cause interstitial cystitis include defects in the lining of the bladder, some of which may cause bladder leakage. Other factors could be an autoimmune reaction, allergies, or infection.

Women are more likely to develop interstitial cystitis than men. There is no cure for interstitial cystitis, but there are therapies, including physical therapy, nerve stimulation, and modification of diet. There is also one medication approved by the FDA to treat interstitial cystitis: Elmiron, made by Janssen Pharmaceuticals.

Elmiron

Elmiron is the brand name for pentosan polysulfate sodium (PPS). Elmiron or PPS allegedly provides a protective coating to a damaged bladder wall. It may coat or even repair the lining of the bladder, potentially reducing leakage and related adverse symptoms. Elmiron was first approved in 1996 to treat interstitial cystitis and painful bladder syndrome.

There are side effects. Patients have reported diarrhea, heartburn, stomach pain, rash, headache, and insomnia. Unfortunately, as I mentioned in a previous post, recent studies indicate a link between Elmiron and vision loss, specifically a retinal condition known as pigmentary maculopathy.

Pigmentary Maculopathy

The macula is the central area of the retina, at the back of the eye. This is the area that receives images and color. It is where most of the “action is” with respect to quality vision. The macula allows us to see with clarity, and it also supports sharp color vision. When the macula is damaged in some way, our vision is also damaged. Pigmentary maculopathy represents several conditions that can affect the central part of the retina or macula. Pigmentary maculopathy may cause a dark spot in a person’s vision that gets worse over time. It can also cause blurred vision, flashing lights, vision distortions, light sensitivity, and other vision problems.

Recent studies show that Elmiron may cause a buildup of pentosan polysulfate sodium (PPS) in the macula, which can result in irreversible retinal damage, which means irreversible vision problems. In some cases, pigmentary maculopathy can lead to blindness.

If you have taken Elmiron to treat interstitial cystitis for an extended period and now have vision problems, you need to seek medical attention as soon as you can. If you would like to discuss whether you may have a case against Janssen Pharmaceuticals, the maker of Elmiron, give me a call: (919) 830-5602.

Elmiron (pentosan polysulfate sodium) is a prescription medication that was approved in 1996 for the treatment of interstitial cystitis. This condition is sometimes referred to as painful bladder syndrome and can consist of a range of symptoms. These can vary from the occasional mild discomfort to constant and significant pain in the bladder or lower abdomen of the body.

Currently, Elmiron is the only FDA-approved oral medication to treat interstitial cystitis. As a result, numerous individuals have taken the medication for an extended period. But over the past few years, several studies have been published that indicate that some people may suffer from vision problems from taking Elmiron. Some of the more notable studies came out in 2018 and 2019.

This blog post will examine the possibility of Elmiron causing vision loss in patients, its current status with the U.S. Food and Drug Administration (FDA), and what its makers, Janssen Pharmaceuticals, Inc. (Janssen) and Johnson & Johnson, potentially face in litigation.

Does Elmiron Cause Vision Loss?

It’s very possible. What’s interesting about this drug is that scientists aren’t even 100% sure how it works. According to the FDA, it’s believed that Elmiron attaches itself to the inside of the bladder to reduce any irritating effect urine may have on the bladder wall.

The FDA now reports that long-term use of Elmiron may cause pigmentary maculopathy. This is the technical term for pigment changes in the retina of the eye.

The retina is the back of the eye that contains many of the cells (such as rods and cones, if you recall from your elementary or middle school days) and nerves that make vision possible. Unfortunately, the FDA doesn’t know exactly how or why Elmiron harms the retina.

Reported symptoms of pigmentary maculopathy include:

• Trouble adjusting vision to low-light environments
• Blurred vision
• Difficulty reading, especially in reduced light

Most instances of pigmentary maculopathy have occurred in patients who have taken Elmiron for more than three years. However, there are reports of vision problems in those who have used Elmiron for shorter periods.

One of the most troubling aspects of these vision problems is that they are very similar to age-related macular degeneration and pattern dystrophy. So it’s very possible that many patients were misdiagnosed with one of these eye conditions. And as a result, they continued taking Elmiron, further worsening the damage to their retinas.

Has the FDA Done Anything About Elmiron?

Yes, but not much. On June 16, 2020, the FDA approved Janssen’s request for a labeling change. Specifically, the “Warnings” section will now mention pigment changes to the retina. Before this change, there was nothing listed under the Warnings section. This follows what other governmental regulatory agencies are doing.

For example, as early as June 2019, the European Medicines Agency recommended Elmiron labeling changes to reflect the newly recognized risk of pigmentary maculopathy.

Are There Any Elmiron Lawsuits?

Yes, there are a few. Given how recent these Elmiron developments are, there aren’t a large number of lawsuits and many have been filed just this year. This means they’re in the very early stages of litigation.

In Allen v. Janssen, the plaintiff filed a proposed class-action lawsuit in May 2020 where she seeks a declaration that Elmiron is a defective drug, medical monitoring and damages. The plaintiff argues that the defendants did not properly test Elmiron, did not report the risk of vision problems to the FDA and failed to warn users of Elmiron of its risks.

Another case, Pisco v. Janssen, involves a plaintiff arguing strict liability and negligence causes of action against the defendants. Plaintiff seeks a variety of damages, including pain and suffering, medical costs and lost wages.

There have been tens of thousands of patients who took Elmiron. So many more cases are likely. However, it’s very early in the litigation process, so not much is happening right now. But if there’s a notable development, I will keep you updated. If you have any questions, you can call me at (919) 830-5602.

But let’s back up.

What is Risperdal?

Risperdal is an anti-psychotic drug that was approved for limited use in 1993 to manage the symptoms of schizophrenia. According to multiple sources, in the years that followed Johnson & Johnson pressed the FDA for approval to treat other conditions, such as bipolar disorder and autism, and to permit use in children. Risperdal was soon prescribed for adults and children to treat attention deficit hyperactivity disorder, anxiety and depression. Treating these conditions using Risperdal is considered an “off label” use, which is the use of a drug in a manner unapproved by the FDA. Off-label use could involve using a drug to treat a condition which is not authorized by the FDA, or prescribing the drug to an unapproved age group. Shockingly, Risperdal has had horrific side effects in children. Among other symptoms, Risperdal can cause the growth of female breasts in male children, a condition known as gynecomastia. I have written about Risperdal often in this blog. You can check out those articles here.

The Case of Andrew Yount

Andrew Yount is a boy from Tennessee who was prescribed Risperdal in 2003 to treat attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder. At the time the FDA had not approved the drug for use in treating behavior disorders in children. Andrew was just five years old when he began taking the drug. A year after taking Risperdal, Andrew grew female breasts.

Andrew Yount is now in his late teens. He has had to deal with this embarrassing disfigurement for most of his life.

At trial, the lawyers for Andrew and the Yount family argued that Janssen Pharmaceuticals and its parent company Johnson & Johnson were aware of the risks of children growing female breasts but worked to downplay the risk involved. Despite the data showing a connection between use of Risperdal and the growth of female breasts in vulnerable boys, Janssen and Johnson & Johnson kept pushing the prescription to doctors and parents and children.

What the Jury Saw

The jury reviewed the evidence and concluded that Janssen and Johnson & Johnson failed to warn the Yount family about the risks of taking Risperdal. The jury also seems to have concluded that the defendant companies intentionally buried or falsified scientific evidence showing a link between Risperdal and gynecomastia. If this is true (and evidence supports the view), then it represents hideous behavior from the companies. The jury in the Yount case clearly saw this horrific corporate behavior and awarded Andrew Yount a huge monetary award. But just as likely, the jury got angry and awarded this money as a signal to Johnson & Johnson that this kind of corporate greed will be severely punished. The hope is that jury verdicts like this one will discourage Johnson & Johnson and all pharmaceutical companies to recommit to developing and testing and marketing safe and effective drugs.

Naturally, Janssen and J&J have stated they will appeal the verdict.

Other Risperdal Cases

I wrote about the Austin Pledger trial from last fall, which resulted in a $2.5 million verdict and which you can read about here. Other Risperdal trials have yielded jury awards ranging from $500,000.00 to $1.75 million. One jury trial ended in a defense verdict for Janssen and Johnson & Johnson, though I would not put much stock in that outcome, as plainly the plaintiffs are winning many more of these cases than they are losing. After this latest huge loss in the Yount case, Johnson & Johnson would be wise to consider settling many of the more than 1,500 cases still in the pipeline. Another Risperdal case goes to trial in Philadelphia later this month. I’ll let you know how it turns out.

The Takeaway

For much of my life I have mainly believed that pharmaceutical companies develop and market drugs with the overarching goal to improve and extend the lives of patients. But this is not always the case. Sometimes a company can become blinded by greed. Companies may then push an untested drug onto the market, or even sell a drug it knows to be unsafe. So be skeptical. Do some research. Ask your doctor many questions about the latest drug she wants to prescribe for you or your child. Get a second or a third opinion. You can never eliminate all risk, but you can at least learn how a product reached the market, whether it was adequately tested, and even whether lawsuits have been filed against the drug maker.

The case is titled A. Y. v. Janssen Pharmaceuticals, Pennsylvania Court of Common Pleas (No. 130402094)

Photographs for illustrative purposes only.