Elmiron Vision Loss Lawsuits

FDA Adds WARNING Labels to the Packaging

Elmiron Used for Bladder Pain Could Cause Vision Loss and Blindness

A popular medication for painful bladder syndrome, or bladder cystitis, appears to cause severe vision problems. Patients who’ve taken Elmiron, manufactured by Janssen Pharmaceuticals, face a much higher risk of macular degeneration, maculopathy, and even blindness.

elmiron lawsuits

The vision damage from Elmiron can be subtle and easy to miss during a routine eye exam. Some Elmiron patients are diagnosed with age-related macular degeneration because doctors may not make the connection between vision loss and the toxicity of this medication.

In October 2019, the Review of Ophthalmology published research clearly linking Elmiron to serious eye and vision damage. The study found that patients exposed to Elmiron had a significantly higher risk of getting a macular degeneration or retinal maculopathy diagnosis as a direct result of taking the drug. The researchers write that what they uncovered is “suggestive of a preventable, vision-threatening medication toxicity.

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Elmiron Lawsuits in Federal Courts and an Elmiron MDL

So far, about 100 people have filed lawsuits in federal courts over vision-related injuries due to Elmiron. On December 15, 2020, the federal court system ordered the creation of a “Multi-District Litigation” (“MDL”) to handle Elmiron injury claims. An “MDL” is process where a single judge manages many similar cases at the same time. Unlike a “class action”, in which many people’s cases are combined into one large case moving toward one large trial, an MDL allows multiple separate, but similar, cases to move through the “pre-trial” stages of litigation together. When those cases are ready for trial, the MDL sends the individual cases back to local federal courts for individual trials. In the order creating an MDL over Elmiron claims, the Court said:

The actions involve common factual issues concerning the propensity of Elmiron to cause retinal injuries, notably atypical or pigmentary maculopathy. Several defendants have marketed Elmiron since its approval in 1996. This litigation likely will implicate complex scientific and regulatory issues.

In the coming months, this MDL will allow more formal litigation to begin so that attorneys can gather and review evidence from the companies that make and sell Elmiron. This will allow victims who’ve filed lawsuits to confirm what Janssen Pharmaceuticals knew about Elmiron causing irreversible eye damage, and when they knew about it.

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Our attorneys represent people across the entire United States. We are not local personal injury attorneys. We are a medical product liability law firm with decades of experience in Federal and State courts all over the country. We have the reputation of aggressively and successfully representing our clients against huge corporations during negotiations and in jury trials.

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Medical product liability lawsuits are NOT simple personal injury cases. Your attorney must have an understanding of complex medical issues involving these defective devices and drugs.  The medical product liability team at mctlaw helps clients every day with rare and complicated medical diagnoses. We thoroughly review clients’ medical records to find evidence to support their claims.

FDA Warning for Elmiron and Vision Loss 

The FDA just approved new warning labels for the drug in June 2020. Elmiron packaging now carries a label telling patients about the higher risk of retinal pigmentary changes. The label says vision damage usually happens after taking Elmiron for 3 years or longer, but that it can cause problems in less time.

The FDA advises patients to get extensive vision testing while taking Elmiron. It also suggests genetic testing in cases where there’s a family history of age-related macular degeneration (AMD).

The symptoms listed on the new labels include:

  • Difficulty Reading
  • Slow adjustment to low or reduced light
  • Blurred vision

Unfortunately, until June 2020, the packaging for Elmiron did not include any type of warnings for retinal maculopathy despite the earlier research showing the link between the drug and vision problems.

Elmiron and Interstitial Cystitis or Chronic Bladder Pain

Interstitial cystitis is known to cause chronic pain in the bladder and pelvis and makes people feel like they constantly have to urinate. It affects more than 1-million patients each year, most of them women. There are only 2 treatments approved for Interstitial cystitis, including Elmiron. The FDA approved Elmiron in 1996. Elmiron is the brand name for “pentosan polysulfate sodium.” This drug is intended to help regulate irritation of the bladder by binding to the cells in the lining of the bladder and reducing the painful and chronic urge to urinate.