Update: Emory Eye Center Study “Patient Zero” Files Lawsuit Over Elmiron Side Effects
A woman whose case was documented as “Patient Zero” in a 2018 study conducted by physicians at the Emory Eye Center in Atlanta, Georgia, has filed a lawsuit seeking compensation for eye problems she allegedly suffered after taking Elmiron. Plaintiff Valarie Hull of South Carolina claims she took Elmiron from 2001 to 2018, and as a result, developed serious visual injuries including changes in eye color pigment, severe vision degradation, loss of night vision, and pigmentary maculopathy.
Hull was treated by Dr. Nieraj Jain, an ophthalmologist at Emory Eye Center. In 2018, Jain and other researchers published their findings, based on Hull and 5 other patients with the same eye problems who all took Elmiron. The lawsuit accuses Janssen Pharmaceuticals, Teva Branded Pharmaceutical Products R&D, Teva Pharmaceuticals, and Teva Pharmaceutical Industries Ltd. of failing to warn of the risk of severe eye and vision-related injuries with Elmiron. The complaint is: Hull vs. Janssen Pharmaceuticals Inc., et al., Case No. MIDL003646-20.
What is Elmiron?
Elmiron (generic: pentosan polysulfate sodium) is the only medicine approved by the U.S. Food & Drug Administration (FDA) to treat 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.
Bladder Medication Linked to Eye Damage: AAO Study
A 2018 study published by the American Academy of Ophthalmology (AAO) described the cases of 6 female patients that took Elmiron for interstitial cystitis who had been diagnosed with retinal maculopathy, also known as pigmentary maculopathy or retinal pigmentary endothelium injury (RPE). The report concluded that Elmiron may be toxic to the retina, a thin layer of tissue at the back of the eye whose purpose is to convert light into neural signals which are then sent to the brain for visual recognition.
Kaiser Study Reveals Danger of Long-Term Elmiron Use
The AAO study led researchers at Kaiser Oakland to examine its database for patients who had been prescribed Elmiron for painful bladder and had also suffered from eye damage. The researchers found 140 patients in the system who had taken an average of 5,000 Elmiron pills each over the course of 15 years. Of the 140 patients, 91 agreed to undergo an eye exam during which researchers took detailed images of the backs of their eyes.
Twenty-two of the 91 participants had clear symptoms of Elmiron toxicity. The rate of toxicity rose with the dosage of Elmiron taken, from 11% of those taking 500 to 1,000 grams to 42% of those taking 1,500 grams or more.
The findings indicated that about 25% of patients who’d taken large doses of Elmiron had signs of eye damage, and that damage caused by the drug could be mistaken for other retinal conditions, such as age-related macular degeneration or pattern dystrophy.
“It’s unfortunate,” said Dr. Robin Vora, lead author of the study. “You have a patient with a chronic condition like interstitial cystitis, for which there is no cure and no effective treatment. They get put on these medications because it’s thought to have few side effects and few risks, and no one thinks about it again. And year after year, the number of pills they’re taking goes up and up.”
100+ Reports of Eye Damage in Elmiron users: FDA Warning
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.
Retinal 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)
What are Elmiron Lawsuits Alleging?
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.
Elmiron Side Effects
- Eye damage
- Retinal maculopathy
- Pigmentary maculopathy
- Retinal pigmentary endothelium injury (RPE)
- Alopecia (hair loss)
- Gastroesophageal reflux
- Skin rash
- Sleep disorders
- And more
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.
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 suffered eye damage after taking Elmiron, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.