A popular prescription drug known as Elmiron has been treating people with bladder issues and pain for nearly 20 years. There are many people claiming that Elmiron is causing vision damage. Following the allegations, many people are filing lawsuits against the makers of Elmiron claiming the makers did not warn of the risks of using the drug and potential vision issues.

What is Elmiron?

Elmiron, also known as pentosan polysulfate sodium (PPS), is a prescription drug that doctors prescribe to patients who suffer from bladder pain from interstitial cystitis. It works by forming a layer around the walls of the bladder and preventing irritation and pain caused by certain bladder conditions. Elmiron is in hard gelatin 100 mg capsules and prescribed patients take them about three times a day. At this time, this drug is the only drug on the market to relieve the pain and treat cystitis.

Elmiron’s advertised possible negative side effects include:

  • Hair Loss
  • Nausea
  • Abdominal pain
  • Bruising
  • Diarrhea
  • Gastroesophageal reflux
  • Headaches
  • Dizziness
  • Rash
  • Depression
  • Skin rash
  • Sleep disorders

How is Elmiron Allegedly Harming people?

Although Elmiron is a medication for bladder issues, many people are claiming the drug is negatively affecting another part of their body, the eyes. Many are claiming that Elmiron is toxic to the retina in your eye and causing vision damage. There are claims that people that have taken Elmiron over a long period of time are developing maculopathy. Maculopathy is a medical condition in the macula which is located in the back center of the retina and is responsible for our central vision.

According to a study performed in 2018, Nieraj Jain, M.D reported vision changes and difficulty reading amongst 6 people who were taking Elmiron for an average of 15 years. Between the 6 people, ages ranged from 37-62 years of age, they all displayed signs of changes in their retina. The patients showed that they began having trouble reading in dim light and other vision issues. Because of the results, it led researchers to issue a warning that the long-term use of Elmiron can potentially cause retinal damage.

In 2019, Janssen Pharmaceuticals added warnings of vision damage/loss to Elmiron’s label in Canada and Europe. However, Janssen Pharmaceuticals did not update the United States label until recently, June 2020, where they added vision loss to the warning label.

In January of 2020, a study was conducted for Elmiron by a group of doctors to test the toxicity of Elmiron for vision damage from a collection of patients. The doctors selected the patients from a group of 140 that took over 5,000 pills over 15 years. Following, 91 of the patients agreed to take a vision exam and doctors performed a vision exam by taking images of the back of their eyes. The doctors then found that 22 of the people showed signs of drug toxicity after further examination.

The Symptoms

Many people are reporting numerous injuries in relation to the eyes that have previously taken Elmiron. The most common injuries reported include:

  • Distorted or blurred vision
  • Diminished eyesight
  • Difficulty reading
  • Difficulties seeing objects that are close
  • Eye strain or fatigue after screen time
  • Raised time to adjust to darkness or dim lighting
  • Difficulty adjusting to dim lighting or the dark
  • Eye pain
  • Visual disturbances such as flashes, moving lights, or shadows

The Elmiron Lawsuit

Many people are filing lawsuits against the makers of Elmiron for allegedly causing damage to their vision. The lawsuit is regarding ‘failure to warn’ of this possible side effect. On the advertised list of warnings and possible side effects, maculopathy was not one of them. Therefore, due to the product liability regulation of ‘failure to warn’ Janssen Pharmaceuticals may be liable for those alleging vision problems due to the usage of Elmiron.

Janssen Pharmaceuticals is the current manufacturer of Elmiron, which is a company owned by Johnson & Johnson. The first lawsuit filed against the company was on May 4th, 2020 where the plaintiff claimed she developed maculopathy after being prescribed Elmiron for her interstitial cystitis. The woman began suffering from vision problems in 2019 after taking the drug since 2012 and was eventually diagnosed with pigmentary maculopathy in both eyes. She states that Janssen Pharmaceuticals never warned of the alleged damages due to taking Elmiron, in relation to eye disease.

Due to the failure to warn, we may see more lawsuits filed against Janssen Pharmaceuticals for the development of vision issues after using Elmiron over an extended period. However, there is no recall on Elmiron at this time, neither voluntary nor an FDA issued recall.

In December of 2020, the United States District Court has officially created an MDL for the Elmiron cases. The Elmiron lawsuits will be combined into an MDL held at the United States District Court of New Jersey.

Do you Qualify?

You may be eligible for compensation for damages for an Elmiron lawsuit if:

  • A doctor prescribed you Elmiron and you took the drug consistently over three years
  • If diagnosed with vision issues including blindness, maculopathy, or other non-age-related eye disorders 

Though the Elmiron lawsuit is not in an MDL, it is important to find proper legal representation. You will need an attorney experienced in product liability and mass tort cases. It is important to find an experienced attorney to help you get the compensation and aid you deserve. Furthermore, if you want to learn more about how mass torts work, read the article where we break everything down for you in simple terms.