Maculopathy

You can develop eye problems, such as maculopathy, for a variety of reasons. Some conditions cannot be prevented. However, some can. If you are taking Elmiron, be aware that using this medication has been linked with serious eye damage.

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What Is Maculopathy?

Maculopathy is “any pathologic condition or disease of the macula, the small spot in the retina where vision is keenest.” This condition is also called macular retinopathy. (1)

Types of maculopathies include: (2) (3) (4)

  • Age-related macular degeneration.
  • Hereditary maculopathies.
  • Cellophane maculopathy.

Age-Related Macular Degeneration

Age-related macular degeneration is common. In people 50 years and older, this condition is a leading cause of vision loss. (5) This condition develops when the central portion of the retina, the macula, degenerates. When this occurs, side or peripheral vision may remain intact, but central vision is often lost. (6)

Approximately 11 million people in the United States have age-related macular degeneration. (7)

If you suffered vision damage after taking Elmiron, you may be eligible for compensation.

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The dry form is the most common type of age-related macular degeneration, approximately 85-90 percent of all cases. In this type, yellowish deposits build up beneath the retina, causing progressive vision loss. This form typically affects both eyes, though vision loss typically occurs in one eye before the other. (8)

Ten to fifteen percent of dry form age-related macular degeneration cases progress to the wet form. The wet form of age-related macular degeneration “is characterized by the growth of abnormal, fragile blood vessels underneath the macula. These vessels leak blood and fluid, which damages the macula and makes central vision appear blurry and distorted.” Unfortunately, the wet form can cause severe, rapid vision loss. (9)

Hereditary Maculopathies

You can also develop problems with your retinas because you have an inherited maculopathy. Hereditary maculopathies include:

  • Doyne honeycomb retinal dystrophy (DHRD): This condition generally begins to show itself in early to mid-adulthood. It does lead to vision loss, but that loss varies from person to person. DHRD is characterized by small, round, white spots called drusen accumulating beneath the pigmented layer of the retina, known as the retinal pigment epithelium. The National Institutes of Health’s (NIH’s) National Center for Advancing Translational Sciences notes, “Over time, drusen may grow and come together, creating a honeycomb pattern.” (10)
  • Stargardt disease: This typically autosomal dominant eye disease, according to the American Academy of Ophthalmology, “is the most common hereditary macular dystrophy, with a prevalence of 1 in 10,000, and it accounts for approximately 7% of all retinal dystrophies.” This condition, characterized by “beaten-bronze” or a “bull’s-eye” pattern macular lesions, usually shows up in children and young adults before they turn 20 years of age. For someone diagnosed with this disease, the prognosis is poor. Visual acuities tend to range from 20/200 to 20/400. (11)
  • North Carolina macular dystrophy: Researchers named this autosomal dominant disorder after working with a large North Carolina family who had descended from three Irish brothers. Other cases have been discovered in affected families throughout the world. The condition begins to show itself in infants or at birth. Visual acuity generally ranges from 20/20 to 20/200. (12)
  • Sorsby fundus dystrophy, also called Sorsby pseudoinflammatory macular dystrophy: This rare, progressive autosomal dominant retinal dystrophy can lead to bilateral central vision loss. Usually, this condition does not show itself until you are in your 30s or 40s. (13)
  • Best vitelliform macular dystrophy, also known as Best disease: Onset of this autosomal dominant, progressive condition begins in childhood. The prognosis is relatively good. Visual acuity remains pretty good over time. However, in the disease’s later stages, central vision loss may occur. (14)
  • Adult vitelliform macular dystrophy, or adult-onset foveomacular vitelliform dystrophy: This condition refers to a group of diseases that are similar to Best disease. However, these diseases do not show signs until patients have reached young or middle adulthood, unlike Best disease. The prognosis overall is favorable. (15)
  • Congenital retinoschisis, or juvenile X-linked retinoschisis: This disease is rare and progressive. Usually, this X-linked recessive disease is first detected in childhood. Children with the disease have decreased central vision. Roughly 1 in 5,000 to 1 in 25,000 people worldwide may have this condition, which “is the most common juvenile-onset macular degeneration in males.” (16)
  • Dominant cystoid macular dystrophy, or dominant cystoid macular edema: This condition is extremely rare and progressive. This disease usually first appears at 30 years of age or older. The visual prognosis is usually poor. (17)
  • Central areolar choroidal dystrophy: This rare disease usually first shows up between the ages of 20-40. Central visual deterioration is progressive. The final visual prognosis is poor, often worse than 20/200. (18)

Cellophane Maculopathy

Cellophane maculopathy is known by multiple names, including macular pucker, retina wrinkle, premacular fibrosis, internal limiting membrane disease, and surface wrinkling retinopathy. A macular pucker refers to scar tissue that forms on the macula. Some people do not experience any vision loss due to a macular pucker, whereas, although rarely, some experience severe vision loss. (19)

As the NIH’s National Eye Institute notes, people with a macular pucker “may notice that their vision is blurry or mildly distorted, and straight lines can appear wavy. They may have difficulty in seeing fine detail and reading small print. There may be a gray area in the center of your vision, or perhaps even a blind spot.” Most of the time, vision does not progressively worsen with cellophane maculopathy. (20)

Elmiron and Maculopathy

Elmiron is approved as a treatment for interstitial cystitis. Interstitial cystitis is a chronic condition affecting the bladder. Symptoms include bladder pressure, bladder pain, and occasionally, pelvic pain. The pain can range from mild to severe. If you have this condition you may also feel like you need to urinate more frequently. (21)

Studies have linked Elmiron used in patients with interstitial cystitis to retinal damage. An article published by the American Academy of Ophthalmology described patients treated at Emory Eye Center who presented with a unique pigmentary maculopathy after taking Elmiron for interstitial cystitis. (22) This study is one among many that have been recently published. (23) (24) (25)

At least one recently published article has found that even after Elmiron is discontinued, the maculopathy that has been linked with its use may continue to worsen. (26)

Are you or a loved one experiencing vision loss after taking Elmiron? Call us today for a free consultation.

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Filing Lawsuits for Elmiron and Maculopathy Injuries

If you took Elmiron, you may now have been diagnosed with specific types of maculopathies. These include pigmentary maculopathy, retinopathy, degenerative maculopathy, macular or pattern dystrophy, or retinal pigment epithelium atrophy.

Symptoms of these eye diagnoses may include:

  • Vision loss.
  • Vision impairment.
  • Scotoma.
  • Halo vision.
  • Unilateral (one eye) or bilateral (both eyes) blindness.
  • Blurred vision.
  • Metamorphopsia (distortion of linear objects or lines; such that they appear curved).
  • Reduced night vision.

Lawsuits are being filed accusing Elmiron’s manufacturer, Janssen Pharmaceuticals (owned by Johnson & Johnson), of failing to properly warn the public about the risk of vision loss or other eye problems. In one such lawsuit, a woman claims to have “sustained retinal damage and impaired vision as a result of taking the prescription drug Elmiron to treat a bladder pain syndrome known as interstitial cystitis.” (27)

According to the lawsuits, many patients, studies, and government agencies “have established that Elmiron causes retinal damage.” However, these suits claim, “defendants have failed to warn, advise, educate or otherwise inform Elmiron users, prescribers or governmental regulators in the United States about the risk of pigmentary maculopathy or the need for medical, ophthalmological monitoring.” (28)

As of June 2020, the Elmiron warning label now warns “pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of Elmiron. 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.” (29)

How W&L Can Help

Weitz & Luxenberg is currently accepting cases involving clients who have been diagnosed with certain types of maculopathy after taking Elmiron.

If you or a loved one has been diagnosed with maculopathy after using Elmiron, you may be entitled to financial compensation. We can help you explore your legal options.

We have a team of attorneys with experience in pharmaceutical product liability law. As a national personal injury law firm, we have dedicated ourselves to helping clients harmed by defective drugs for more than three decades.

“When you are prescribed a drug to help relieve your symptoms of interstitial cystitis, you expect it to be safe,” says Danielle Gold, lead Elmiron attorney for W&L. “However, some patients taking Elmiron have developed serious vision problems and the retinal damage may be irreversible. This is a devastating injury and we plan to hold the defendants accountable.”

W&L attorney Ms. Gold has been appointed to serve on the Plaintiffs’ Executive Committee in the Elmiron multidistrict litigation (MDL) centralized in the District of New Jersey. Discovery is underway and a Science Day presentation is scheduled.

Our attorneys have secured billions of dollars in verdicts and settlements on behalf of our clients. Among our successes are:

  • $9 billion — W&L helped secure a jury verdict of $9 billion on behalf of a client who developed bladder cancer after taking Actos, a diabetes drug.
  • $13.5 million — W&L achieved a $13.5 million verdict on behalf of our client who had taken the pain medication Vioxx. He and many others suffered heart attacks after taking this medication to treat arthritis and other pain conditions.

  1. Shiel, Jr., W.C., (n.d.). Medical Definition of Maculopathy. Retrieved from https://www.medicinenet.com/script/main/art.asp?articlekey=32564
  2. Boyd, K. (2020, February 28). What Is Macular Degeneration? Retrieved from https://www.aao.org/eye-health/diseases/amd-macular-degeneration
  3. American Academy of Ophthalmology. (n.d.). Hereditary Maculopathies. Retrieved from https://www.aao.org/focalpointssnippetdetail.aspx?id=04233cba-5975-42fa-81a2-a87ae19edebd
  4. National Eye Institute. (2019, July 8). Macular Pucker. Retrieved from https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/macular-pucker
  5. American Optometric Association. (n.d.). Macular Degeneration. Retrieved from https://www.aoa.org/healthy-eyes/eye-and-vision-conditions/macular-degeneration?sso=y
  6. Boyd, K. (2020, February 28). What Is Macular Degeneration? Retrieved from https://www.aao.org/eye-health/diseases/amd-macular-degeneration
  7. MedlinePlus. (2020, August 18). Age-related macular degeneration. Retrieved from https://medlineplus.gov/genetics/condition/age-related-macular-degeneration/#frequency
  8. Ibid.
  9. Ibid.
  10. National Center for Advancing Translational Sciences. (2014, October 20). Doyne honeycomb retinal dystrophy. Retrieved from https://rarediseases.info.nih.gov/diseases/1912/doyne-honeycomb-retinal-dystrophy
  11. American Academy of Ophthalmology. (n.d.). Hereditary Maculopathies. Retrieved from https://www.aao.org/focalpointssnippetdetail.aspx?id=04233cba-5975-42fa-81a2-a87ae19edebd
  12. Ibid.
  13. Ibid.
  14. Ibid.
  15. Ibid.
  16. Ibid.
  17. Ibid.
  18. Ibid.
  19. National Eye Institute. (2019, July 8). Macular Pucker. Retrieved from https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/macular-pucker
  20. Ibid.
  21. Mayo Clinic. (2019, September 14). Interstitial cystitis. Retrieved from https://www.mayoclinic.org/diseases-conditions/interstitial-cystitis/symptoms-causes/syc-20354357
  22. Pearce, W.A., et al. (2018, May 22). Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium. Retrieved from https://www.aaojournal.org/article/S0161-6420(17)33695-3/abstract
  23. Wang, D., et al. (2020, April). Pentosan-associated maculopathy: prevalence, screening guidelines, and spectrum of findings based on prospective multimodal analysis. Retrieved from https://www.sciencedirect.com/science/article/pii/S0008418219312724
  24. Barnes, A.C., et al. (2020, May 21). Pentosan Polysulfate Maculopathy versus Inherited Macular Dystrophies: Comparative Assessment with Multimodal Imaging. Retrieved from https://www.sciencedirect.com/science/article/abs/pii/S2468653020302001
  25. Shah, R., et al. (2020 July 9). Disease Course in Patients With Pentosan Polysulfate Sodium – Associated Maculopathy After Drug Cessation. Retrieved from https://jamanetwork.com/journals/jamaophthalmology/fullarticle/2768082
  26. Ibid.
  27. Carroll, M. (2020, May 16). Janssen Pharmaceuticals will fight bladder drug claims outlined in Florida lawsuit. Retrieved from https://flarecord.com/stories/537128828-janssen-pharmaceuticals-will-fight-bladder-drug-claims-outlined-in-florida-lawsuit
  28. Ibid.
  29. U.S. Food & Drug Administration. (n.d.). Drug Safety-related Labeling Changes (SrLC). Retrieved from https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2277

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