What is Elmiron?

Elmiron (pentosan polysulfate sodium) is a brand-name drug manufactured by Janssen, a subsidiary of Johnson & Johnson. The drug was originally developed by Teva Branded Pharmaceutical Products R&D and licensed to Janssen. 

Elmiron is the only drug specifically approved by the U.S. Food & Drug Administration (FDA) for the treatment of interstitial cystitis, a painful, chronic bladder condition. It has been on the market since 1996, and is not available in generic form.  The medication is offered only in capsule form, with most users taking three 100 mg capsules per day. 

Researchers don’t know exactly how Elmiron works. It is believed to build up or create a buffer for the lining of the bladder, protecting the bladder from irritants. 

What’s Wrong with Elmiron? 

In 2018, a doctor in Georgia noted that several patients who had taken or were taking Elmiron were suffering from a similar retinal problem. In response to his warning, doctors with a large medical organization identified more than 100 patients who had taken the drug long-term. Among those who agreed to be examined, they reported that 24% showed clear signs of toxicity. 

That initial small study revealed that the likelihood of retinal damage increased with the amount of the drug a patient had taken over time. 

The condition, known as pigmentary maculopathy, may eventually lead to blindness. Some earlier-stage signs include: 

• Difficulty reading
• Difficulty adjusting to low lighting
• Visual disturbances
• Eye pain
• Blurred vision

More advanced pigmentary maculopathy may result in dark spots in the field of vision.

How is Pigmentary Maculopathy Diagnosed?

The macular degeneration believed to be caused by long-term use of Elmiron is typically diagnosed through an ocular scan. The two types of scans most commonly used to diagnose pigmentary maculopathy are relatively quick, non-invasive procedures. 

The drug’s manufacturer suggests regular eye examinations during treatment with Elmiron.

Is Elmiron Still on the Market?

Elmiron has not been recalled or withdrawn from the market in the United States. However, in 2020, the FDA approved changes to the medication’s labeling that warned of reported changes in the retina, typically after three years or more of use, but sometimes occurring sooner. The label further notes that “cumulative dose appears to be a risk factor.” 

It is recommended that anyone commencing treatment with Elmiron undergo a baseline retinal examination within six months, and then continue periodic assessments as long as treatment is underway.

The manufacturer has indicated that it does not intend to withdraw the drug, which has remained profitable despite patent expiration and the new warnings regarding potential permanent vision damage or blindness.

Elmiron Litigation

As of October 15, 2021, there are 580 Elmiron lawsuits pending in the multi-district litigation (MDL) in the U.S. District Court for the District of New Jersey. The MDL includes cases filed all over the country that have been gathered together in one court to simplify the litigation process. This clustering of cases can streamline the exchange of information, save all parties time and money, and allow the judge overseeing the MDL to become more fully educated about the relevant science. 

In MDL, the parties choose a small number of cases to be tried early on. These cases, known as “bellwether cases,” offer an opportunity for the court and the attorneys on both sides to learn more about what to expect in other, similar cases. This greater understanding of how cases are likely to play out can make it easier to settle claims, which can significantly speed up the process of securing compensation for people harmed by the drug. 

What Should I Do if I Took or Am Taking Elmiron?

If you took Elmiron for an extended period of time or are still taking the drug, your next steps depend on whether you have been diagnosed with pigmentary maculopathy, have experienced symptoms but have not been diagnosed, or have no symptoms but are concerned about possible damage to your retina. 

Even if you have no symptoms, it is a good idea to consult an eye doctor to determine whether you should have a retinal scan. Damage may be visible before you experience symptoms, and the sooner you find out about it, the better. This is important even if you have stopped taking Elmiron. A 2020 study concluded that the progression of both symptoms and structural changes may continue long after the patient stops taking the drug. 

If you have suffered visual disturbances, blurred vision, loss of ability to adjust to dim lighting, or other visual impairment after taking Elmiron for an extended period, or have been diagnosed with pigmentary maculopathy after taking Elmiron, you should also consult an attorney experienced with pharmaceutical product liability cases and familiar with the Elmiron litigation. 

How Much are Elmiron Visual Damage or Blindness Claims Worth? 

Every case is different, and Elmiron litigation is still in the early stages. No attorney can tell you with certainty how much your case is worth today, or guarantee you a minimum settlement or verdict. Generally, the type of damages that may be available in a pharmaceutical product liability case include: 

• Compensation for medical expenses associated with the harm caused by the drug
• Compensation for lost income due to the harm caused by the drug
• Compensation for expenses that were necessary due to the harm caused by the drug, such as accessibility modifications and assistance
• Compensation for non-economic damages like pain and suffering and loss of enjoyment of life

Depending on the circumstances, punitive damages may also be awarded. Punitive damages aren’t intended to compensate for specific losses. Instead, they are meant to punish the defendant for wrongdoing and give the company and others a good reason not to do something similar in the future.

An Elmiron litigation attorney can provide a more detailed assessment of the strength of your claim and the types of compensation that may be available. The next step is easy. Just fill out the form on this page right now and we’ll connect you with an attorney in your area.