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FDA Warns of Serious Long-Term Eye Damaged from the Drug Elmiron

Anyone that has been using the drug Elmiron to treat bladder conditions should be aware of the growing tide of concerns regarding the long-term safety of this popular drug. After an initial wave of reports linking the use of Elmiron to serious vision impairment, the Food and Drug Administration (FDA) has recently stepped in and required the manufacturer of Elmiron to add a “black box” warning label. The new warning label alerts doctors and patients that Elmiron may cause a rare eye disease called pigmentary maculopathy that can cause vision impairment or blindness. The new warning label comes just as Elmiron lawsuits are already being filed across the country

Elmiron and Interstitial Cystitis

Interstitial cystitis is an ailment involving the urinary tract system that causes chronic bladder and abdominal pressure and pain. The condition is a part of a spectrum of diseases known as Bladder Pain Syndrome. More than one million people in the United States, mostly women, are estimated to have the condition.

The drug Elmiron has been sold in the U.S. since 1996 by Janssen Pharmacy (a subsidiary of Johnson & Johnson).  Since its creation, Elmiron has been promoted as a safe and reliable treatment for users who suffer from interstitial cystitis. Today Elmiron is the primary method of treatment for interstitial cystitis and Janssen has generated hundreds of millions of dollars in annual revenue from sales of the drug.

Elmiron Safety Concerns

Until very recently, Elmiron was considered a very safe drug with little known side effects or dangers. That all changed very rapidly in 2019 when a series of studies and scientific case reports revealed that patients who had used Elmiron for extended time periods were suddenly developing a rare eye condition called pigmentary maculopathy. Maculopathy is a disease of the macula, the small spot in the retina where vision is keenest. The studies have linked Elmiron to a specific type of maculopathy which causes permanent vision loss, blurry vision, and prolonged adaption to dim light.

The initial Elmiron studies prompted the FDA to launch its own independent investigation.  While the final results of that examination are still pending, the FDA announced on June 16, 2020 that Elmiron will now be sold with new, heightened warning labels. These new warning labels specifically disclose the potential link between prolonged use of Elmiron and the development of “Retinal Pigmentary Changes.” These new warning labels are intended to alert the public and doctors alike to the potential dangers of using Elmiron for long time periods.

In light of the new warnings and recent findings, medical experts are recommending that anyone who has previously used Elmiron should have an ophthalmic examination for early detection of maculopathy. Early detection is essential for treatment. Common early symptoms of maculopathy are:

  • Having difficulty reading;
  • the difficulty of seeing close objects;
  • vision becomes dim;
  • loss of detailed vision;
  • darkened vision;
  • deterioration of the eyes;
  • spot of vision loss in the field of vision.

Elmiron is currently the only interstitial cystitis prescription available on the market. This means countless thousands of Americans have been put at risk for developing maculopathy and other serious side effects, including permanent eye damage.

This is the first time the information has been added to labels in the United States. While most patients remain unaware of the potential vision loss and side effects, they may have avoided permanent retinal damage if earlier warnings had been provided about the risks.

While the medical community has recently learned of the adverse effects associated with the drug, Elmiron’s manufacturer has known of the potential long-term damage for over 20 years.  It was reported that in early clinical trials, patients who took Elmiron for  three to four years, reported vision and eye-related side effects.

Drug manufacturers are responsible for ensuring the safety and efficacy of their products before allowing for public consumption. Not doing so has increased the likelihood of thousands of lawsuits across the United States.

Contact Us About Elmiron Lawsuits

If you or someone you know has used Elmiron and has since developed serious vision impairments, getting in touch with an experienced attorney can help you in receiving compensation. Our firm is currently accepting new Elmiron cases from anyone who took Elmiron for at least 6 months and was subsequently diagnosed with maculopathy or a similar eye condition.

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