Elmiron Side Effects Include Macular Degeneration and Pigmentary Maculopathy
Written by: Lauren Schwab, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
Elmiron (pentosan polysulfate sodium) was approved by the FDA on September 26, 1996, for the treatment of painful bladder syndrome (interstitial cystitis). More recently, however, Elmiron has been linked to cases of eye damage and vision-related injuries.
Elmiron Studies on Side Effects
Several studies, including a May 2018 study and an April 2019 study conducted by Emory Eye Center, have shown a connection between Elmiron and severe eye disorders, such as macular degeneration (maculopathy), more specifically pigmentary maculopathy. Macular degeneration is a serious eye disorder, typically classified by symptoms such as central vision loss, blurred, dimmed or spotty vision, prolonged dark adaptation, and blindness.
According to a report from Science Direct, Kaiser Permanente conducted a study reviewing medical records from nearly 4.3 million patients taking Elmiron. The study found that as the quantity and dosage of Elmiron increased, so did the amount of the patient's eye damage, i.e., dose-response relationship.
Label Warning Discrepancies
The underlying claim for Elmiron lawsuits being filed against the manufacturing company Janssen Pharmaceuticals and other drug companies is a failure to properly warn doctors and patients about the potential risks of vision problems associated with Elmiron.
Despite claims of eye damage from Elmiron, the label and prescribing information for Elmiron in the US remarkably still states "Warnings: None". In October 2019 Health Canada required the Elmiron label to be changed,with pigmentary maculopathy added to the "Warnings and Precautions", "Post-market Adverse Drug Reactions", and "Consumer Information" sections of the label. The United States, however, the FDA has not required any such changes be made to the Elmiron label
Case Criteria and Current Litigation
There are currently several pending Elmiron lawsuits. The first lawsuit was brought against Teva Branded Pharmaceutical Products R&D, Teva Pharmaceuticals USA, Inc., Janssen Pharmaceuticals, Inc, and Johnson & Johnson, Inc. This Elmiron lawsuit in the United States District Court for the District of Connecticut.
The typical Elmiron lawsuit involves a woman between the ages of 30 to 60 who had ingested Elmiron for at least one year at a dosage of at least 100mg. The patient who is the plaintiff in the Elmiron lawsuit was diagnosed with a vision-related Elmiron side effect such as wither pigmentation maculopathy, pigmentation macular degeneration, pigmentation maculitis, retinal maculopathy or dry macular degeneration. Significantly, the patient does not need to be taking Elmiron up until the time of their Elmiron side effect diagnosis, unlike most drug injury cases.
Our law firm is currently investigating cases involving a vision-related Elmiron side effect as a possible drug injury lawsuit against the responsible pharmaceutical companies.
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