Elmiron Side Effects: Maculopathy
What are the Elmiron Lawsuits About?
Lawsuits against the common bladder medication Elmiron claim that the drug causes an eye disorder known as maculopathy and other disorders within the retina (the light-sensing tissue located at the back of the eye that enables us to see) and may lead to blindness. The lawsuits also allege that the manufacturer of Elmiron, Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson), failed to properly warn the public about the risk of vision problems.
What is Elmiron Supposed to Treat?
Elmiron is a drug intended to treat interstitial cystitis (IC) which causes chronic pain in the bladder and pelvis area due to inflammation. Research estimates that more than one million people in the United States suffer from IC and most of the sufferers are women.
What are the Side Effects of Elmiron?
The current prescription information provided by Janssen Pharmaceuticals about Elmiron lists the drug’s basic side effects and warnings (see below), but does not provide any information about the risk of maculopathy—the disease that affects the macula—or other visual changes or conditions as a result of taking the medication.
- Hair loss
- Bloody stool
- Abnormal liver function tests
Visual Side Effects of Elmiron:
- Conjunctivitis (“pinkeye”)
- Optic neuritis (inflammation of optic nerve)
- Amblyopia (“lazy eye”)
- Retinal hemorrhage (bleeding in retina)
What is Maculopathy?
Maculopathy is a progressive disease that can result in vision loss—usually in both eyes. The disease impacts the part of the eye located in the back of the retina which is called the macula. The macula controls your ability to read, see fine details in objects, recognize faces and colors, and focus central vision.
This is a unique type of maculopathy which has only been found in people taking Elmiron. The condition is distinguishable from age-based degeneration in that it causes a unique pigmentary maculopathy during exposure to Elmiron.
What is the Link Between Elmiron and Maculopathy?
Researchers at Emory University first discovered the potential link between Elmiron (pentosane polysulfate sodium) and Maculopathy (specifically, pigmentary maculopathy) in 2018 when 6 patients were suffering from the condition but did not have any previous retinal issues in their medical history. Researchers discovered that the common thread between all 6 patients was their long-term use of Elmiron.
In Summer 2019, Kaiser Permanente in California followed up on the 2018 study. In the Kaiser Permanente study, 91 of the patients who were taking an average of 5000 Elmiron pills over 15 years participated. Of those 91 participants, 22 participants were found to have significant damage to their retina associated with drug toxicity. The rate of toxicity increased with the amount of Elmiron that had been consumed—from 11% of those taking 500 to 1000 grams to 42% of those taking 1500 grams or more.
Through the studies, researchers identified the following symptoms as being associated with Elmiron-related Maculopathy:
Symptoms Associated with Elmiron-Related Maculopathy from Studies:
- Difficulty reading
- Difficulty adapting to dim lighting
- Areas of vision loss in field of vision
- Problem seeing options that are close-up
- Vision dimming
Several subsequent studies have since been performed by researchers where a statistically significant link between long-term Elmiron usage and maculopathy were identified.
A 2019 Harvard study has noted that the condition can worsen over time and is not likely reversible.
GoldenbergLaw Can Help
GoldenbergLaw is currently investigating cases where an individual has taken Elmiron long-term and suffered harm to the eye. We have been litigating complex cases for over thirty years and will fight to bring you the justice and gold standard of advocacy that you deserve.