A 2018 study published by the American Academy of Ophthalmology described the cases of 6 patients who had been diagnosed with pigmentary maculopathy, also known as macular degeneration, after being prescribed Elmiron for interstitial cystitis. The study was updated in 2019 stating that 10 additional patients at Emory Eye Center had developed symptoms of maculopathy from Elmiron.
What’s the Problem?
At least 100 complaints involving “eye disorders” in patients treated with Elmiron were filed with the FDA Adverse Event Reporting System (FAERS) from 1997 to 2019. Eighty of the reports were classified as serious, and 22 listed maculopathy as the specific condition.
Lawsuits allege that the labeling of Elmiron does not include a warning about pigmentary maculopathy or any other form of the disease. The only mention of potential vision problems with the drug are found in the Adverse Reactions section, and reference nystagmus, conjunctivitis, optic neuritis, amblyopia, and retinal hemorrhage.
What is Elmiron?
Elmiron (generic: pentosan polysulfate sodium) is a weak blood-thinner approved to treat bladder pain caused by interstitial cystitis, better known as “painful bladder syndrome.” The drug is also used for the treatment of osteoarthritis in humans, horses and elderly dogs. Pentosan polysulfate works by forming a layer on the bladder wall and protecting it from harmful/irritating substances in the urine. Elmiron is manufactured by Janssen Pharmaceuticals, and was approved by the U.S. Food & Drug Administration (FDA) in September 1996.
Elmiron Side Effects
- Pigmentary maculopathy
- Alopecia (hair loss)
- Gastroesophageal reflux
- Skin rash
- Sleep disorders
- And more
Pigmentary maculopathy is a painless disease characterized by progressive loss of central vision that impairs eye function, according to MedicineNet. The condition may occur in patients who do not notice any eye problems, since a healthy eye may compensate for vision loss in the other. When symptoms do present, they include:
- Difficulty reading
- Prolonged dark adaptation
- Image distortion, or metamorphopsia, where objects appear deformed or smaller than they actually are.
Anyone with these symptoms should make an appointment with a vision care specialist.
Factors that may increase your risk of macular degeneration include:
- Taking Elmiron
- Being 50 or older
- Having myopia
- Having one eye that has previously been affected by the disease
- Having other risk factors identified by a routine ophthalmologic exam
Eye Care Tips
- Get a comprehensive dilated eye exam
- Find out if you’re at risk for eye diseases
- Take care of your health
- Protect your eyes
- Give your eyes a rest from reading / computer (take a break every 20 minutes and look at something about 20 feet away for 20 seconds)
- If you wear contacts, take steps to prevent eye infections
(source: National Eye Institute)
Can I File a Class Action?
Although Schmidt & Clark, LLP, is a nationally recognized class action firm, we have decided against this type of litigation when it comes to Elmiron. Our lawyers feel that if there is a successful resolution to these cases, individual suits, not class actions will be the best way to get maximum payouts to our clients. If you’ve been injured by Elmiron side effects, we know you’ve suffered emotionally and economically, and want to work with you personally to obtain the maximum compensation for the damages caused by your injuries. Contact us today to learn more about your legal rights.
Do I Have an Elmiron Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Elmiron lawsuits. We are handling individual litigation nationwide and currently accepting new maculopathy cases in all 50 states.
Again, if you or a loved one has been diagnosed with pigmentary maculopathy after taking Elmiron, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.