Kirkendall Dwyer LLP

Elmiron Lawsuit - Will There Be An Elmiron Recall For Vision Damage?

What is Elmiron?

Elmiron is an FDA-approved medication used to treat painful bladder pain and discomfort caused by interstitial cystitis. The drug has been on the market since the late ’90s and is the only drug approved to treat interstitial cystitis.

Interstitial cystitis is a medical condition that affects millions of people but is much more prevalent in women. Many patients use Elmiron long term to treat this painful disease.

Are There Side-Effects To Taking Elmiron?

Elmiron’s warning label previously included common side-effects such as headaches, diarrhea, dizziness, and weight gain.

But recent lawsuits accuse Janssen Pharmaceuticals, the maker of Elmiron, for failing to warn the public about the risk of vision damage. 

Elmiron’s warning label previously included common side-effects such as headaches, diarrhea, dizziness, and weight gain.

But recent lawsuits accuse Janssen Pharmaceuticals, the maker of Elmiron, for failing to warn the public about the risk of vision damage. 

Recent FDA Label Change

On June 16th of 2020, the FDA released information in regards to Elmiron that included an update to their warning label.  According to the FDA, cases have been identified in long term users of Elmiron, seeing retinal pigmentary changes known as maculopathy. 

Elmiron warning label now includes on their list of adverse reactions, retinal pigmentary changes.

The FDA recommends that anyone considering taking Elmiron should receive retinal exemptions after six months of taking the medication.

What Is Maculopathy?

Maculopathy is a retina disease that causes vision damage. Issues include blurred vision and sensitivity to light environments. This eye disease changes the center of the retina and may lead to permanent loss of central vision.

Elmiron Lawsuits

The risks of taking Elmiron long-term were unknown until 2015, when multiple women in Atlanta developed the same eye-condition after taking the medication for multiple years. 

Currently, there are about 50 cases pending in federal and state courts across the United States. Most cases are being reported by patients who have been taking Elmiron for one year or longer.

The Elmiron litigation is still in the beginning stages, but because tens of thousands of people have potentially taken Elmiron, attorneys expect the litigation to grow.

Elmiron Full List of Side Effects

  • Hair loss
  • Nausea
  • Diarrhea
  • Blood In Stool
  • Upset Stomach
  • Headache
  • Rash
  • Dizziness
  • Bruising 
  • Weight Gain

The updated label now includes side effects such as:

  • Blurred Vision
  • Difficulty Reading
  • Distorted Vision
  • Eye Pain
  • Issues Adjusting To Darkness
  • Vision Problems
  • Vision Loss

If any patient has experienced changes in their vision such as difficulty reading, slow adjustment to low or reduced light, or wavy vision in the center of their field, they should see their healthcare professional immediately.

Who Is Being Affected By Elmiron?

Interstitial cystitis is diagnosed more frequently in women than in men. Doctors typically prescribe Elmiron to females over the age of 16. Women aged 50+ are so far the most affected population.

What To Consider Before Taking Elmiron?

Patients who are considering taking Elmiron should speak to their healthcare professional and note any family or personal history of eye disease. Any patient who already suffers from eye disease should not use Elmiron as a way to manage interstitial cystitis.

Patients should have regular eye exams before and during treatment. Eye exams should include checking the retina for detection of pigmentary maculopathy. Healthcare professionals can then help you decide if Elmiron is the right treatment for you.

Patients should discuss any questions or concerns about taking Elmiron with their healthcare professional.

Will Elmiron be Recalled?

As of September 2020, the FDA has not announced any plans to recall Elmiron. Janssen Pharmaceuticals has only added the potentially permanent vision damage to their warning label and has not pulled Elmiron from the market.

A total recall of the medication at this time is unknown

Elmiron Lawsuit

Are you taking Elmiron and have experienced vision loss? We are accepting cases from patients who have taken Elmiron for at least two years. 

Vision problems that have started while taking Elmiron or within a year of stopping treatment may have a case.

At Kirkendall Dwyer LLP we can help you hold pharmaceutical companies accountable for mishandling side effects and not warning patients. 

We can help you with a free case review to determine whether or not you have a solid case and deserve compensation for vision damage and any other losses due to taking Elmiron medication. 

Our Goal

Our goal at Kirkendall Dwyer LLP is to help you with personal injuries that have taken a toll on the quality of your life. We have a long history of helping clients with compassionate, caring service. 

With our extensive experience, we know exactly what it takes to get you back on your feet after a devastating loss.  You can feel certain that our dedicated attorneys will fight for your rights and get you the justice you deserve.

If you find yourself in a personal injury situation due to taking Elmiron, please contact us and begin the recovery process today.

FREE Elmiron Case Evaluation