Elmiron (PPS) eye disorders and vision problems: FDA adds Elmiron to drug list of "Potential Signals of Serious Risks."
James T. Snyder Law, PLLC, is taking cases of eye disorders and vision problems in adults who took pentosan polysulfate sodium (PPS), also known as Elmiron. The U.S. Food and Drug Administration recently added eye disorders related to Elmiron to its drug list of “Potential Signals of Serious Risks” generated by its Adverse Event Reporting System, and is currently evaluating the need for regulatory action regarding Elmiron.
What is Elmiron?
Elmiron is a prescription medication approved by the FDA to treat interstitial cystitis (“IC”), or “painful bladder syndrome” and osteoarthritis. Interstitial cystitis is a chronic condition affecting the bladder and pelvis, and presents as urinary urgency and frequent urination, often in small amounts. This condition mostly affects women. Elmiron, which is manufactured by Janssen Pharmaceuticals, is the world’s only PPS medication; there are currently no generics or therapeutically-equivalent versions of Elmiron available in the U.S.
Eye Damage Associated with Elmiron:
Recent studies show that patients taking Elmiron may develop a rare but serious eye disease called retinal maculopathy. Similar to macular degeneration, this condition alters pigment cells in the retina, changing the eye color while causing significant eye damage and vision loss. Symptoms for patients experiencing Elmiron-associated eye damage include:
- Change in eye color;
- Blurred vision;
- Difficulty reading;
- Difficulty adapting to dim lighting;
- Difficulty reading;
- Difficulty in adapting to dim lighting;
- Dark spots in center of vision;
- Straight lines appearing curved or squiggly; and
- Muted, less vivid colors.
In 2017 the Emory Eye Center in Atlanta, Georgia began studying a new eye disease, “retinal maculopathy” in patients. Emory discovered that every patient in the study with this eye disease had been taking Elmiron (PPS):
https://www.ncbi.nlm.nih.gov/pubmed/29801663
Shortly thereafter, Kaiser Permanente Northern California, Oakland, found even more patients in their database with retinal maculopathy and eye damage who had taken Elmiron:
https://www.aaojournal.org/article/S0161-6420(20)30040-3/abstract
On November 6, 2019, the Harvard Medical School Department of Ophthalmology issued a similar report regarding PPS-associated maculopathy associated with chronic use of the drug Elmiron, which potential for eye damage progression continued for six (6) years after discontinuance of the drug:
A list of these medical studies regarding Elmiron and retinal maculopathy from the Interstitial Cystitis Network (“ICNetwork”), including active links to many of these reports and more, is included here:
https://www.ic-network.com/long-term-pentosan-elmiron-use-may-be-linked-to-retinal-disease/
The FDA recently added eye disorders related to Elmiron to its drug list of “Potential Signals of Serious Risks” generated by its Adverse Event Reporting System, and is currently evaluating the need for regulatory action:
These eye disorders that damage your retina may be irreversible. In worst-case scenarios, you could lose your vision entirely.
Consult your doctor before stopping any prescribed medication.
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Drug manufacturers are responsible for ensuring the safety and efficacy of their products before marketing them for public consumption. Failure to do so is considered negligent and grounds for litigation.
If you or someone you know in New York State was diagnosed with an eye disorder or vision problems such as maculopathy, pigmentary maculopathy, retinopathy, degenerative maculopathy/macular degeneration, macular retinopathy, macular/pattern dystrophy, or retinal pigment epithelium atropy resulting in scotomas, vision loss, halo vision unilateral blindness, or blurred vision after taking the medication Elmiron (PPS) for interstitial cystitis or osteoarthritis, you may be entitled to compensation.
For a free, no-obligation personal and confidential consultation about your legal rights or those of another in New York regarding any such eye disorder or vision diagnosis linked to taking Elmiron (PPS), call us at 315-884-8888 or send us an email inquiry using this link:
https://www.jimsnyderlaw.com/contact
We promise to respond immediately.