Van Wey, Metzler & Williams


What is Elmiron®?

Elmiron, scientifically known as pentosane polysulfate sodium (“PPS”), is an oral medication that is prescribed to treat bladder pain or discomfort that is typically associated with interstitial cystitis. In the last few years it has been discovered that consistent use of Elmiron can lead to the deterioration of a consumer’s macular, a part of the eye that allows people to see. Research studies show that Elmiron is unique in deteriorating this part of the eye and consumers can experience blurriness that can lead to permanent vision loss.

This medication is manufactured by Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson, and remains the only FDA approved medication to treat interstitial cystitis. Elmiron is a prescription medication and, surprisingly, its manufacturers have conceded that it is “not known exactly how Elmiron works.” Currently PPS exists only as the brand Elmiron, with no generic versions, even though the Elmiron patent expired in 2010. The FDA requires such a high level of data from manufacturers that would want to provide a generic version of the medication that it is unlikely an generic version will be produced any time soon; therefore, Janssen continues to hold a monopoly over this medication in the United States. Conversely, there are generic versions in other countries such as Europe and Canada.

Patients are typically advised to take a recommended dose of three capsules (200 to 400mg) per day over a considerable amount of time (several years) for relief from interstitial cystitis symptoms. Although it is unclear how the medication truly works, it is believed that Elmiron acts as a type of chemical Band-Aid on the bladder by slowly coating the bladder lining to lessen the pain and irritation experienced from interstitial cystitis. Unfortunately, only about 6% of the medication is actually absorbed into the body. The rest of the medication can become a “load” in the body, which is later excreted. With such a high recommended dosage, there is more load building up in the body than medication absorption, which can be an issue.

What is Interstitial Cystitis?

Interstitial cystitis is a chronic bladder condition that can cause pain and pressure in the bladder and pelvic area. This disorder usually causes urgent and frequent urination, as frequent as sixty times a day. Although much research has been conducted into interstitial cystitis, no one knows the exact cause of the disorder and it seems to occur rather spontaneously. However, it has been found that interstitial cystitis disproportionately affects women over the age of 30. At this time there is no cure for interstitial cystitis but Elmiron remains one of the medications offered to provide some relief.

What research has been conducted on Elmiron and what does it tell me?
Has Janssen been involved in any legal proceedings?

Even though research has proven a connection between taking Elmiron and incurring maculopathy for some patients, there have not been any FDA recalls of the medication and lawsuits are only just beginning. From individual lawsuits to class actions, Janssen Pharmaceuticals is beginning to be held responsible for the harm that they have caused.

Earlier this year, a lawsuit was filed against Janssen Pharmaceuticals by Ms. Pelczar for vision loss that she was experiencing as a result of taking Elmiron. Ms. Pelczar began taking Elmiron in 2005 to combat symptoms from her interstitial cystitis, ten years later she began suffering from eye problems and vision loss. For the next four years, from 2015 to 2019, Ms. Pelczar saw medical providers about her visual symptoms and was ultimately diagnosed with a type of permanent retinal injury and vision loss caused by Elmiron toxicity. The complaint that was filed states that Janssen failed to properly warn physicians and the public that Elmiron could cause vision problems and claims that they actively hid the side effects from the public.

Recently, a class action was filed against Janssen and Johnson & Johnson in the United States District Court for the Eastern District of Pennsylvania. Similar to Ms. Pelczar’s case, this action alleges that the company has never provided any warning of maculopathy or retinopathy associated with use of the drug or warned patients to have regular eye exams to monitor vision while using the drug and seeks class certification to assist patients with these eye exams to monitor their vision.

These are just a couple examples of the litigation that is starting to take place against Janssen for the harm brought forth by Elmiron. If you or a loved one have been taking this medication and have been experiencing vision complications, please do not hesitate to reach out for a consultation.

What are the complications from taking Elmiron?

How Can We Help You?

If you or someone you love have been experiencing the symptoms above after taking Elmiron, contact us today to further evaluate your rights to compensation.

Here at Van Wey, Metzler & Williams, we have more than 100 combined years of experience fighting against a healthcare industry that seems to put profits over patients. This includes doctors, hospitals, and the manufacturers of medical devices. The Elmiron medication and its manufacturer, Janssen, have had issues with failing to warn consumers of the negative impact this medication can have on vision and can be subject to suit to repay you for your injuries.

If you or someone you love has consistently been taking Elmiron and are experiencing vision issues, please call us or submit your case for evaluation today.

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