Elmiron Vision Loss

Elmiron is a drug prescribed to treat a diagnosis of Interstitial Cystitis. Interstitial Cystitis is also sometimes referred to as Bladder Pain Syndrome and mostly affects women.

In 2018, an article published in the Journal of American Academy of Ophthalmology revealed that patients had been diagnosed with retinal maculopathy after being treated with Elmiron for a diagnosis interstitial cystitis. Maculopathy refers to a variety of pathological disorders of the central part of the retina, known as the macula.  If the condition is untreated, it can result in serious, long-term vision impairment or loss.

On June 16, 2020, the FDA approved a change to the warning label for Elmiron to now include the following:

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. Detailed ophthalmologic history should be obtained in all patients prior to starting treatment with ELMIRON®. If there is a family history of hereditary pattern dystrophy, genetic testing should be considered. For patients with pre-existing ophthalmologic conditions, a comprehensive baseline retinal examination (including color fundoscopic photography, ocular coherence tomography (OCT), and auto-fluorescence imaging) is recommended prior to starting therapy. A baseline retinal examination (including OCT and auto-fluorescence imaging) is suggested for all patients within six months of initiating treatment and periodically while continuing treatment. If pigmentary changes in the retina develop, then risks and benefits of continuing treatment should be re-evaluated, since these changes may be irreversible. Follow-up retinal examinations should be continued given that retinal and vision changes may progress even after cessation of treatment.

What is Elmiron?

Elmiron is known scientifically as pentosan polysulfate sodium (PPS).  It is used to treat a diagnosis of interstitial cystitis.

Is Elmiron Dangerous?

Some studies have suggested that Elmiron is associated with the occurrence of a significant disorder of the eye.  The link between Elmiron and retinal maculopathy was discovered by researchers associated with the Emory Eye Center at the Emory University Medical School.  The researchers observed that those who were treated for a diagnosis of interstitial cystitis with Elmiron on a long-term protocol between 2015 and 2017 were at an increased risk for developing retinal maculopathy. These subjects reported significant difficulty reading and adapting in low-light situations.  The authors concluded that a connection exists between this form of maculopathy and chronic exposure to Elmiron that merits further exploration.  They also urged patients who have taken Elmiron to be screened regularly by an ophthalmologist if they experience unusual vision symptoms and to discontinue use of Elmiron if they are diagnosed with an eye disease.

Elmiron Side Effects and Complications

The most serious complication associated with Elmiron is retinal maculopathy.  Early symptoms of Maculopathy may include:

  • Difficulty reading;
  • Difficulty adjusting to darkness;
  • Difficulty seeing close objects;
  • Dimness in vision; and
  • Blind spot(s) in visual field.

Other potential symptoms of retinal maculopathy include:

  • Eye pain;
  • Vision irregularities; and
  • Permanent vision loss.

Elmiron Lawyers

Contact our Elmiron Attorneys to review whether you or a loved one may be entitled to financial compensation. Our firm is currently accepting Elmiron cases on behalf of potential clients in all 50 states.

If you or someone you know has taken Elmiron and suffers from any vision complications, contact one of our Elmiron Injury Lawyers today so that we can evaluate your claim.

Elmiron Vision Loss

Elmiron is a drug prescribed to treat a diagnosis of Interstitial Cystitis. Interstitial Cystitis is also sometimes referred to as Bladder Pain Syndrome and mostly affects women.

In 2018, an article published in the Journal of American Academy of Ophthalmology revealed that patients had been diagnosed with retinal maculopathy after being treated with Elmiron for a diagnosis interstitial cystitis. Maculopathy refers to a variety of pathological disorders of the central part of the retina, known as the macula.  If the condition is untreated, it can result in serious, long-term vision impairment or loss.

On June 16, 2020, the FDA approved a change to the warning label for Elmiron to now include the following:

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. Detailed ophthalmologic history should be obtained in all patients prior to starting treatment with ELMIRON®. If there is a family history of hereditary pattern dystrophy, genetic testing should be considered. For patients with pre-existing ophthalmologic conditions, a comprehensive baseline retinal examination (including color fundoscopic photography, ocular coherence tomography (OCT), and auto-fluorescence imaging) is recommended prior to starting therapy. A baseline retinal examination (including OCT and auto-fluorescence imaging) is suggested for all patients within six months of initiating treatment and periodically while continuing treatment. If pigmentary changes in the retina develop, then risks and benefits of continuing treatment should be re-evaluated, since these changes may be irreversible. Follow-up retinal examinations should be continued given that retinal and vision changes may progress even after cessation of treatment.

What is Elmiron?

Elmiron is known scientifically as pentosan polysulfate sodium (PPS).  It is used to treat a diagnosis of interstitial cystitis.

Is Elmiron Dangerous?

Some studies have suggested that Elmiron is associated with the occurrence of a significant disorder of the eye.  The link between Elmiron and retinal maculopathy was discovered by researchers associated with the Emory Eye Center at the Emory University Medical School.  The researchers observed that those who were treated for a diagnosis of interstitial cystitis with Elmiron on a long-term protocol between 2015 and 2017 were at an increased risk for developing retinal maculopathy. These subjects reported significant difficulty reading and adapting in low-light situations.  The authors concluded that a connection exists between this form of maculopathy and chronic exposure to Elmiron that merits further exploration.  They also urged patients who have taken Elmiron to be screened regularly by an ophthalmologist if they experience unusual vision symptoms and to discontinue use of Elmiron if they are diagnosed with an eye disease.

Elmiron Side Effects and Complications

The most serious complication associated with Elmiron is retinal maculopathy.  Early symptoms of Maculopathy may include:

  • Difficulty reading;
  • Difficulty adjusting to darkness;
  • Difficulty seeing close objects;
  • Dimness in vision; and
  • Blind spot(s) in visual field.

Other potential symptoms of retinal maculopathy include:

  • Eye pain;
  • Vision irregularities; and
  • Permanent vision loss.

Elmiron Lawyers

Contact our Elmiron Attorneys to review whether you or a loved one may be entitled to financial compensation. Our firm is currently accepting Elmiron cases on behalf of potential clients in all 50 states.

If you or someone you know has taken Elmiron and suffers from any vision complications, contact one of our Elmiron Injury Lawyers today so that we can evaluate your claim.

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