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Is There an Elmiron Recall?

Is there an Elmiron recall? As of early 2021, no, but…

Elmiron Complications: Brief Background

Elmiron Recall and FDA Warning - Riddle & BrantleyElmiron (pentosan polysulfate sodium), is a prescription drug approved to treat the discomfort and pain caused by interstitial cystitis (IC), a painful bladder condition which can be helped by medication but not cured. Common side effects of taking Elmiron include diarrhea, nausea, and hair loss. However, rare yet serious side effects include serious eye damage and vision problems, sometimes resulting in partial or total vision loss. As of now there is not an Elmiron recall despite studies linking long-term use of this drug to eye damage and vision loss.

Despite there being no Elmiron recall, the Food and Drug Administration (FDA) has issued a warning and the manufacturer has added a warning label to Elmiron packaging.

History of Elmiron

The FDA approved Elmiron in 1996. A subsidiary of Johnson and Johnson, Janssen Pharmaceuticals, manufactures the drug. Currently, there are no generic versions of Elmiron, and it is the only oral drug approved to treat bladder discomfort and pain. The majority of people who use Elmiron are women. Interstitial cystitis affects between 3 and 8 million women and 1 to 4 million men, according to the Interstitial Cystitis Association.

Elmiron Eye Damage Warning

In June 2020, Janssen added a side effect warning for retinal pigmentary maculopathy which is an eye disorder that damages the retina. Symptoms of retinal pigmentary maculopathy include:

  • Difficulty reading
  • Blurred vision
  • Trouble adjusting to low light environments
  • Eye pain
  • Distortion of straight lines (lines appearing curved)

The damage to the retina can be irreversible and may progress even after stopping the medication.

Elmiron Recall and Lawsuits

IMPORTANT: As of January 2024, we are no longer investigating or taking new Elmiron cases. 

There have not been any recalls on Elmiron. However, studies from 2018 to 2020 have linked Elmiron to vision loss and other eye problems.

Researchers have linked long-term use of the drug to an uncommon type of maculopathy called pigmentary maculopathy. Even though Janssen Pharmaceuticals added a warning for retinal pigmentary changes, the FDA has not yet released a recommendation for an Elmiron recall or safety communication.

Elmiron Lawsuits

Elmiron Lawsuits - Riddle & BrantleySome patients who have suffered vision damage after taking Elmiron have filed lawsuits against Janssen Pharmaceuticals. These lawsuits state that Janssen knew the drug could possibly cause vision problems and failed to warn patients and doctors.

If you or a loved one has experienced changes in vision or vision loss potentially due to Elmiron, contact your healthcare provider immediately.

Riddle & Brantley is representing clients who have suffered vision loss or other eye damage potentially due to Elmiron.

Injuries that may qualify you for an Elmiron lawsuit include:

IMPORTANT: As of January 2024, we are no longer investigating or taking new Elmiron cases. 

Experienced Elmiron Attorneys

At Riddle & Brantley, we help injured victims hold pharmaceutical companies accountable for not warning patients of the adverse side effects of drugs and other negligence. We’ve recovered millions of dollars in compensation (see disclaimer below) for injury victims.

We will be happy to help you with a free consultation and case review to determine whether or not you have a solid case and deserve compensation for vision damage and other losses due to taking Elmiron.

At Riddle & Brantley our goal is to help you secure compensation for personal injuries that have taken a toll on you or your loved one’s quality of life. We help clients with compassionate and caring service.

Please call 1-800-525-7111 or fill out the short form below for a FREE, no-obligation consultation with an experienced Elmiron lawsuit lawyer.

“This settlement changed me and my family’s lives.”

Linda B., Riddle & Brantley client

Our dangerous drug lawyers have over 220+ years of combined experience and can help you get on your feet and reclaim your quality of life after a devastating loss.

Our dedicated attorneys will always fight for your rights and see the maximum compensation you deserve. If you’ve suffered injury potentially due to Elmiron, call 1-800-525-7111 today and let’s see how we can help.

Justice Counts.


*** Disclaimer: The results mentioned are intended to illustrate the type of cases handled by the firm. These results do not guarantee a similar outcome, and they should not be construed to constitute a promise or guarantee of a particular result in any particular case. Every case is different, and the outcome of any case depends upon a variety of factors unique to that case.