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

A growing body of research points to dangerous and previously undisclosed side effects of a popular medicine used to treat bladder issues. In this two-part article, we explain what it can mean to you.

Do you trust the drugs you take to be safe and effective? Certainly, many of us feel compelled to take some medicine from time to time and it seems that the American public, in general, are confident in the drugs they take. In fact, if data gathered in 2015 and 2016 still holds true today, it is likely that as much as 45.8 percent of the US population used prescription drugs in the past 30 days. The prevalence of the use of over-the-counter drugs is even higher. According to the Consumer Healthcare Products Association, a staggering 81 percent of American adults “use OTC medicines as a first response to minor ailments.”

There seems to be little correlation, however, between the widespread use of prescription or over-the-counter drugs and the level of trust the general public has in big drug manufacturers. In one 2019 survey, only 44 percent of American respondents said they trusted in the pharmaceutical industry. That percentage was lower in only 5 other countries meaning that the US drug manufacturers and distributors are among the least trusted in the world–at least among their target consumer base.

These statistics should hardly surprise anyone who has been following the news. Throughout the last decade, the US pharmaceutical industry’s reputation has been marred by scandals and controversies. Allegations raised against key manufacturers and distributors have been many and serious–regarding anything from negligence through illegal marketing practices and fraud to irresponsibility in having played a substantial role in the escalation of the national opioid epidemic. Even well-respected and widely trusted pharmaceutical companies such as Johnson & Johnson, or extremely popular drugs like Risperdal, are now targets of investigations and lawsuits initiated by both private individuals and state governments. 

Recently, a growing body of research has exposed a previously unknown, dangerous side-effect of another popular drug–Elmiron®. These discoveries have sparked a new wave of lawsuits against the drug manufacturer, Janssen Pharmaceuticals, claiming that the company failed to properly warn the public of the risk of eye damage from using Elmiron®. In this two-part article, we provide a comprehensive overview of this story and present information that may be useful to those who suspect they may have experienced eye damage due to Elmiron® use.

Elmiron® and Interstitial Cystitis

Elmiron® is the brand name of a prescription drug containing pentosan polysulfate sodium. In the US, the drug is produced by Janssen Pharmaceuticals and was approved by the Food and Drug Agency (FDA) in 1996. Elmiron® has been available on the market ever since and is currently the only drug approved for the treatment of symptoms associated with a condition known as interstitial cystitis.

Interstitial cystitis, or IC, is a chronic condition manifesting as bladder pressure, bladder pain, or even pelvic pain–all of which can cause considerable discomfort. 

While this condition can affect people of both sexes, there is more prevalence of IC cases among women. It is estimated that in the US alone, IC may affect between 3-8 million women and between 1-4 million men. People of all ages, including children, can develop interstitial cystitis. Currently, there is no known cure for the condition and since it is a persistent ailment, it can adversely affect a person’s quality of life.

Elmiron® was designed to alleviate pain and discomfort caused by IC. Interestingly, while the drug does bring relief to people suffering from bladder issues, the exact biochemical mechanism that allows the medicine to work remains largely unknown. According to the most widely accepted theory, pentosan polysulfate sodium–the active ingredient of Elmiron®–is thought to help replace a damaged bladder surface, serving as an artificial barrier that prevents substances found in urine from causing irritation.

Although any drug may cause some side-effects, ranging from mild to severe, pentosan polysulfate sodium used to be largely regarded as safe. The initial long-term analysis showed a very low amount of “adverse events” in response to the drug, most of which were mild and included diarrhea, nausea, headache, and rash. In some cases, the drug also caused alopecia, or hair loss, but it was reversible. It wasn’t until 2018 that the evidence of previously unknown and extremely dangerous side-effects of Elmiron® began to surface.

Tune in next week for the second part of this article in which we will explain how the risk of severe eye damage related to Elmiron® use was discovered and what legal ramifications it may have for the drug’s manufacturer as well as potential victims.