Have You Suffered Serious Eye Damage After Using Elmiron®?

If So, You May Be Eligible to File A Lawsuit Today.

 

Breaking News: On June 16, 2020, regulators at the Federal Drug Administration (FDA) posted a new Elmiron® warning label, about the risk of serious vision side effects from Elmiron®, an interstitial cystitis drug, that has been linked to reports of a rare retinal disease known as pigmentary maculopathy reported in research among long-term users of the medication. The warning label reads as follows:

“WARNINGS – Retinal Pigmentary Changes. Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON® (see ADVERSE REACTIONS). Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor. Visual symptoms in the reported cases included difficulty reading, slow adjustment to low or reduced light environments, and blurred vision. The visual consequences of these pigmentary changes are not fully characterized. Caution should be used in patients with retinal pigment changes from other causes in which examination findings may confound the appropriate diagnosis, follow-up, and treatment.”

 

Recent research has linked prescription Elmiron® (generic name: pentosan polysulfate PPS), the popular interstitial cystitis (aka. painful bladder syndrome) drug, to a unique form of progressive eye disease, typically diagnosed by ophthalmologists as retinal pigmentary maculopathy, pattern dystrophy, or age-related macular degeneration.

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Elmiron® (aka. pentosan polysulfate sodium, or PPS) was first approved for use for bladder pain in 1996 and is an oral medication (pill). It was thought to provide a “bladder coating effect” to patients by adding an extra coating of protection to the inner bladder walls, which helps to mitigate bladder irritation and discomfort. While the typical dose prescribed by urologists is 300 mg per day (usually in 100 mg doses taken three times per day), it is not uncommon for patients with severe symptoms to be prescribed higher daily doses of 1,000 mg to 1,500 mg per day.

From 2015 to 2018, ophthalmologists at The Emory Eye Center in Atlanta, GA, began finding, through advanced retinal imaging, something they had never seen before – an entirely new eye disease, which was classified as a “retinal maculopathy” – meaning the pigment cells within the eye’s retina literally changed color. This change in color can cause significant vision and eye dysfunction, like the effects seen in patients with age-related macular degeneration. After an exhaustive review of each patient’s medical history, a clear and convincing commonality was found – each patient had been previously diagnosed with interstitial cystitis (painful bladder syndrome) and were currently taking the prescription drug, Elmiron® – a common first-line therapy prescribed by urologists to patients who suffer from painful bladder.

The Manufacturer of Elmiron® Knew Back In The 90’s That Elmiron® Could Cause Serious Eye Injuries –

But Never Listed Them On The Drug’s Warning Label.

When Emory Eye Center of Atlanta first discovered the Elmiron®-associated retinal maculopathy in their patients, before publishing their case series to The Journal of Ophthalmology, they looked back at all the early clinical trials of Elmiron® that were performed by the manufacturer, Janssen Pharmaceuticals, and found that in an unmasked clinical trial of 2,499 patients who took Elmiron® for up to four years, both vision and eye related adverse events were indeed reported.

Janssen Pharmaceuticals knew that patients in the drug’s clinical trials were found to develop optic neuritis and retinal hemorrhage — but failed to list this on the drug’s warning label. Even worse, no further tests or research were done to explore if Elmiron® could cause such serious eye disorders.

It was simply ignored.

After more studies became available showing a link between Elmiron® and serious eye disease, Janssen Pharmaceuticals failed to take any action, such as updating the drug’s warning labels, and remained silent.

What Are The Common Symptoms For Patients Experiencing Elmiron® associated eye damage?

  • Difficulty reading
  • Difficulty adapting to dim lighting
  • Blurred vision (often centrally in the patient’s field of vision)
  • Dark spots in center of vision
  • Straight lines appearing curved or squiggly
  • Muted, less vivid colors

You Should Have Your Eyes Examined If You Have Ever Taken Elmiron®

If you ever took Elmiron®, you should see an ophthalmologist to check for Elmiron®-associated retinal maculopathy. It is important that Elmiron® patients seek a comprehensive eye examination and have the necessary tests to evaluate your retinal health and see if you have an Elmiron® associated eye disease.

Why Choose Brindisi, Murad & Brindisi Pearlman

For Your Elmiron® Lawsuit?

As a result of Janssen’s failure to properly warn patients and doctors of eye disease risks, you, along with your doctor, were not given the opportunity to make a truly informed decision as to whether Elmiron®’s potential benefits were worth the associated eye-related injury risks. If you are a victim of this drug and were not properly warned of eye damage risks, you may be entitled to substantial damages.

We are investigating potential Elmiron® lawsuits on the grounds that Janssen Pharmaceuticals failed to properly warn patients and doctors of known eye-related injury risks.

Our attorneys are nationally recognized and are experienced in all aspects of serious personal injury litigation, including, defective medical drugs litigation. Our law firm has been in business for over 60 years. We know first-hand how devastating it can be to become seriously and permanently injured or harmed as the result of someone else’s negligence.

We are committed to helping victims receive fair and equitable settlements. Our law firm has secured well over $100 million for our clients in verdicts and settlements. The attorneys at Brindisi, Murad & Brindisi Pearlman are focused on personal injury law and fighting for the rights of injured people. If you have suffered Elmiron® associated eye disease, we will fight to help you get the compensation that you deserve.

If You Have Been Injured By Elmiron

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