Living with a chronic condition is challenging enough, but for some, unfortunately, medications can cause serious side effects. Elmiron®, a treatment for bladder pain and inflammation also known as pentosan polysulfate sodium (PPS), is the only FDA-approved oral medication available to treat the chronic bladder condition interstitial cystitis (IC). Women taking Elmiron, for relief from the pain and discomfort caused by IC, have reported experiencing unexpected complications, including a newly discovered, progressive eye disease that may result in permanent vision loss.
UPDATED LABEL WARNS OF PERMANENT VISION LOSS
July 8, 2020
Janssen Pharmaceuticals updated Elmiron’s label in June 2020 to warn of potential damage to the retina and irreversible vision loss that Elmiron could cause. According to the new label, the majority of damage and vision loss were reported in patients who had been taking Elmiron for at least three years, but cases involving patients who took Elmiron for a shorter time were also reported. Read more.
If you’re suffering complications you suspect may be caused by Elmiron, you may have a legal claim. If you took Elmiron long-term to treat bladder pain and inflammation or interstitial cystitis and developed vison complications, you may contact medical drug attorneys Kimberly Barone Baden and Ann E. Rice Ervin by email or call 1.800.768.4026 for more information or to discuss your potential claim.
Elmiron (PPS) side effects
The Emory Eye Center in Atlanta released a study in November 2018 in which it found “a novel and possibly avoidable maculopathy associated with chronic exposure to PPS.” This newly discovered eye disease is often misdiagnosed as retinal pigmentary maculopathy, pattern dystrophy, or age-related macular degeneration.
The American Academy of Ophthalmology found similar results in a study it performed on patients at Kaiser Permanente in Northern California. Roughly a quarter of patients who reported significant use of Elmiron showed signs of eye damage, the study found.
Common signs of Elmiron®-associated eye damage/vision complications may include:
- Difficulty adapting to changes in light
- Blurred vision (often centrally in the patient's field of vision)
- Dark spots in center of vision, blind spots or floaters
- Straight lines appearing curved or squiggly
- Muted, less vivid colors
- Changes in the color of the eye
If you or a loved one took Elmiron and have been diagnosed with one of the following you may have a legal claim:
- Retinal Maculopathy
- Retinal Pigmentary Endothelium Injury (RPE)
- Pigmentary Maculopathy
- Pigmentation Maculopathy
- Pigmentation Macular Degeneration
- Dry Macular Degeneration
Interstitial cystitis mostly affects women and causes chronic pain in the bladder and pelvis. The FDA approved Elmiron in 1996 to treat IC. It is the only FDA-approved oral medication to treat the condition, which is believed to affect roughly a million American women.
Previously manufactured by Baker Norton Pharmaceuticals, the drug is currently owned and manufactured by Janssen Pharmaceuticals, Inc., a Johnson & Johnson subsidiary.
The drug’s label did not warn of potential permanent vision loss or eye damage until the update to the drug’s label was made in June 2020.
Our medical drug litigation experience
Motley Rice medical attorneys have experience litigating for patients alleging they were hurt by dangerous prescription and over-the-counter drugs, including representing clients in large scale litigation against Janssen Pharmaceuticals and Johnson & Johnson. Our attorneys also hold multiple leadership positions in litigation related to defective medical devices or potentially harmful prescription medications.
We understand that as a patient or family member, what you know about the medicines you or your loved one take and the health risks of the medicine may be limited. If you believe a medicine made you sick or hurt you, our attorneys have the resources needed to thoroughly investigate and:
- Identify potentially harmful medicines,
- Determine if the medicine hurt you,
- Review the medicine manufacturer’s compliance with FDA regulations,
- Confirm if the manufacture adequately warned you about potential side effects,
- Identify anything the manufacturer did wrong or illegal concerning your medicine, and
- Recognize other issues that could affect your potential claim.
Always consult a medical professional before stopping or changing any medication.