Elmiron Eye Problems – Elmiron Vision Lawsuits

The drug is, Pentosan Polysulfate Sodium. Elmiron, its trade name, is a carbohydrate derivative. It is a white, odorless powder. When used medicinally, the chemical comes in a capsule form.

Janssen Pharmaceuticals submitted a New Drug Application for Elmiron. FDA approved it on November 8, 2001. It is a semi-synthetically produced heparinlike macromolecular carbohydrate derivative indicated for the relief of pain or discomfort associated with interstitial cystitis.

KBA wrote about the risks concerning Elmiron over a year ago. This was long before most lawsuits began. We wrote that Elmiron could potentially precipitate significant side effects and serious complications. Individuals who have taken or been prescribed this medication should be educated on the important facts about it, as well as the possible adverse impacts it can cause.

Last year, research in a peer-review journal noted, Chronic use of pentosan polysulfate sodium associated with risk of vision-threatening disease. Researchers in February 2020 wrote about possible vision-threatening maculopathy secondary to Elmiron. They conducted a multicenter screening study of patients with IC/BPS. Doctors sometimes diagnosed these as other conditions. For example, one group of authors presented a case of pentosan polysulfate maculopathy originally diagnosed as stargardt disease. 

One report explained

A drug widely prescribed for a bladder condition for decades, now appears to be toxic to the retina, the light sensing tissue at the back of the eye that allows us to see. After an initial report last year that Elmiron (pentosan polysulfate sodium) may be associated with retinal damage, three ophthalmologists conducted a review of patients at Kaiser Permanente in Northern California. They found that about one-quarter of patients with significant exposure to Elmiron showed definite signs of eye damage, and that this medication toxicity could masquerade as other known retinal conditions, such as age-related macular degeneration or pattern dystrophy. The research will be presented today at AAO 2019, the 123nd?Annual Meeting of the American Academy of Ophthalmology.

This report went on to chronicle the timeline. In 2018, Nieraj Jain, M.D., of Emory Eye Center in Atlanta, Ga., reported six patients taking Elmiron for about 15 years developed unusual changes in their macula, which is the central part of the retina. This part of the human eye helps us see clearly. Doctors employ a method called, differential diagnosis, to figure out the cause of conditions like this. These patients did not have any pre-existing conditions that seemed culpable. Diagnostic tests did not help.

Robin A. Vora, M.D , Amar P. Patel, M.D., and Ronald Melles M.D., ophthalmologists at Kaiser Permanente evaluated their patients. Kaiser has a patient database with information concerning millions of patients. The good doctors analyzed it. They found patients with vision problems. They also suggested some misdiagnoses, including retinal dystrophy. They found many patients who Elmiron for over 10 years. Some agreed to submit to vision tests. Some of the patients showed drug toxicity.

You can read some of the research about Elmiron here:

• Progressive maculopathy after discontinuation of pentosan polysulfate sodium RM Huckfeldt, DG Vavvas – Ophthalmic Surgery, Lasers and Imaging …, 2019.
• A Novel Multimethod Image Analysis to Quantify Pentosan Polysulfate Sodium Retinal Toxicity A Hadad, O Helmy, S Leeman, S Schaal – Ophthalmology, 2020 – Elsevie
• Association of macular disease with long-term use of pentosan polysulfate sodium: findings from a US cohort N Jain, AL Li, Y Yu, BL VanderBeek – British Journal of Ophthalmology, 2019

Janssen Pharmaceuticals continues selling the drug. A label we found at FDA does not mention vision problems in it. Maculopathy is not mentioned. There are literally no warnings. A 2004 label remained the same. FDA’s Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System report from July – September 2019 noted that it is looking into drug disorders and evaluating the need for regulatory action. The company revised the label in June 2020. It now has a warning.

Plaintiffs are filing lawsuits. Plaintiffs allege the drug is unsafe and injured the victims. They present product liability claims or negligence claims. In most pharmaceutical lawsuits, attorneys conduct discovery for about a year. They take depositions, hire experts, and make legal arguments. Eventually there is a trial or a settlement.

The first step is retaining an attorney to investigate. Contact KBA is you would like to explore your options.