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SERIOUS EYE CONDITION LINKED TO USE OF ELMIRONĀ®
A bottle of Elmiron capsules.Elmiron® is known scientifically as pentosan polysulfate sodium (PPS).  It is used to treat interstitial cystitis, a urinary tract condition that causes pain in the abdomen, pelvic, and genital regions. The condition may also lead to frequent urination. For those with chronic symptoms, Elmiron is often prescribed for extended periods of time. Less frequently, Elmiron is sometimes used to treat osteoarthritis. 

Eye Damage Associated with Elmiron Use
In 2017 the Emory Eye Center in Atlanta, Georgia began studying an eye condition they had not seen before; “retinal maculopathy”.  Maculopathy refers to a variety of pathological disorders of the central part of the retina, known as the macula.  If left untreated, this condition can result in serious, long-term vision impairment or loss. The Emory Eye Center discovered that every patient in their study diagnosed with retinal maculopathy had been taking Elmiron. However, since Emory's case series consisted of only 6 patients, there wasn't enough data to understand what percentage of people taking Elmiron were affected by retinal maculopathy. More research was needed.

In 2018, an article by the American Academy of Ophthalmology revealed that several patients had been diagnosed with retinal maculopathy after being treated with Elmiron for interstitial cystitis. In December 2019, the Interstitial Cystitis Network conducted a survey of its members taking Elmiron, and the results were shocking! More than half of the patients taking Elmiron who participated in the survey suffered from retinal disease. Yet, the Elmiron packaging contained no warnings whatsoever about adverse effects.

Retinal Maculopathy Symptoms:
This rare but serious eye disease alters pigment cells in the retina, changing the eye color while causing significant eye damage and vision loss. It is often mistaken for a similar condition called macular degeneration.  Symptoms for patients experiencing Elmiron-associated eye damage include:
  • Change in eye color (these may be small spots of color changes in the iris-the  colored part of the eye)
  • Blurred vision (often centrally in the person’s field of vision)
  • Difficulty reading
  • Dark spots in center of vision
  • Difficulty adapting to dim lighting
  • Straight lines appearing curved or squiggly
  • Less vivid colors
Maculopathy In Patients Can Continue to Progress Even After They Stop Using Elmiron!
Perhaps even more frightening, the maculopathy can progress even after the drug has been discontinued.  Dr. Rachel M. Huckfeldt, an ophthalmologist specializing in retinal degeneration at Harvard Medical School, published one of the most concerning case reports regarding the dangers of Elmiron. In October 2019, Dr. Huckfeldt published a case report in the Journal Ophthalmic Surgery Lasers and Imaging chronicling the story of a female eye patient she had treated over the course of an eight year period. Although the patient had stopped using the drug years earlier, the patient continued to see substantial progression of retinal damage and vision loss.

If You Have Ever Taken Elmiron, You Should Get Your Eyes Examined By An Ophthalmologist
The medical community advises that Elmiron users, past and present, should see an ophthalmologist to check for Elmiron-associated retinal maculopathy.  It's important that patients seek a comprehensive examination from an ophthalmologist, not an optometrist. Only an ophthalmologist can perform the necessary exams to determine your retinal health as it relates to Elmiron-associated eye disease.  However, even your ophthalmologist may not be aware of the link between vision problems and Elmiron use.  Be certain to advise of your concerns and let your provider know about the studies referenced above.

The Manufacturer Knew of the Link Between Elmiron and Eye Damage
While the medical community has only recently learned of this connection, it is believed that Elmiron’s manufacturer, Janssen, has known of the link between Elmiron and eye damage for over 20 years.  In early clinical trials of patients who took Elmiron for up to four years, both vision and eye related adverse events were reported. Despite this knowledge, Janssen never added warnings to the label or conducted further research on the link between Elmiron and eye damage.  Instead, they went on to earn billions of dollars selling Elmiron. Janseen is now facing thousands of lawsuits from patients who suffered severe eye damage. 

Elmiron Lawsuits
Drug manufacturers are responsible for ensuring the safety and effectiveness of their products before marketing them for use by the public. Failure to do so can be considered negligence and is grounds for litigation. 

If you have used Elmiron and believe that you may have suffered vision loss or have been diagnosed with macular degeneration or a similar condition, the attorneys at Lacy Katzen LLP can help. We have successfully represented injured patients and their families for over 70 years.
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