Everything You Need to Know About Elmiron® Lawsuits: Part II

How great is the risk associated with long-term Elmiron® use? What kind of damage may it cause to a person’s eyesight? And what legal remedies can the victims take? Read this second installment of our Elmiron® lawsuits mini-series to obtain comprehensive answers to these questions.

Elmiron®, also known by its generic name pentosan polysulfate sodium, is a popular drug manufactured by Janssen Pharmaceuticals. As we discussed in the previous article, the medication is used to treat pain and discomfort caused by interstitial cystitis–a common yet little-understood condition of the bladder that’s affecting millions of Americans. 

Elmiron® was first approved by the Food and Drug Agency (FDA) in 1996 and has been in wide use ever since. For decades, it has been generally viewed as safe. However, this perception has recently been challenged by new scientific discoveries, leading to legal action against Janssen Pharmaceuticals. In this article, we explore how Elmiron® came under increased scrutiny, the risk associated with its use, and what legal options you may have if you have suffered adverse health effects due to regular Elmiron® use.

Elmiron® Safety Concerns on the Rise

As all drugs, Elmiron® is known to cause certain side effects. Up until recently, though, most of such side effects were mild and relatively rare or infrequent. Nevertheless, scientists and doctors started to express concerns about the drug’s overall safety after a study published in 2018 pointed to a previously unknown dangerous secondary effect of long-term exposure to pentosan polysulfate sodium.

That year, a group of researchers from a well-known clinical eye care and research facility in Atlanta, Georgia, presented evidence that Elmiron® use may be related to a higher risk of developing a rare condition known as pigmentary maculopathy. This particular ailment is the result of damage to the central part of the retina known as the macula. It was first discovered in 6 patients with the only common denominator in their medical history being that they had all been taking Elmiron® for about 15 years. 

One year later, a similar study was conducted on a group of about 100 people who also had been regularly using Elmiron® over the course of 15 years. It was discovered that 25 percent of patients in that group also suffered retinal abnormalities. The extent of the damage correlated with the dose of Elmiron® they had been taking–meaning that the more of the drug they had consumed, the greater their retinas were affected. The researchers conducting the study noted that while the damage may have been mitigated if patients stopped taking pentosan polysulfate sodium, one other possible adverse effect of the drug is permanent vision loss. 

Can You File a Claim in Relation to Elmiron® Eye Damage?

The controversy related to Elmiron® and its previously unknown, dangerous side effects is still unfolding. It is expected that as more research is conducted and more pentosan polysulfate sodium users who have suffered adverse health effects come forward, scientists and medical professionals will be able to better understand the relation between the drug and eyesight deterioration. Still, some affected patients have already started taking legal steps to protect their rights and potentially secure the payout of compensation for their injuries from the drug’s manufacturer.

For example, in March 2020, there was a lawsuit filed against Janssen Pharmaceuticals in the United States District Court for the District of Connecticut. The lawsuit alleges that the pharmaceutical company developed and distributed the drug (without full disclosure of risks) in the US market despite knowing better.  

Pharmaceutical companies can indeed be found liable for injuries related to the use of a particular drug if they were aware of the risks associated with the drug and failed to disclose them. A drug manufacturer can also be held responsible for failing to take all the reasonable measures to ensure the drug’s safety. This includes discovering all the potentially dangerous side effects and informing both the regulatory bodies–such as the FDA–and the public about them.

Has Janssen Pharmaceutical been negligent in the way described above when it comes to Elmiron® and its associated risks? This will be decided in the courts throughout the US in the months and years to come. 

You may already consider taking legal action against the pharmaceutical company if you have been using Elmiron® for a considerable time and have experienced the following symptoms:

If you or a family member may have been injured by the long-term use of Elmiron® or another drug and you wish to obtain more information, please visit our dedicated Elmiron® Vision Loss page or contact Ron Bell Injury Lawyers for a free consultation.