Individuals who were treated with Elmiron and suffered from maculopathy and other serious eye conditions may be eligible to pursue a claim and seek financial compensation.
Elmiron is a medication for interstitial cystitis, a medical condition better known as “painful bladder syndrome” which causes chronic pain in the bladder. Elmiron is also given to patients suffering from osteoarthritis. In May 2020, lawsuits were filed against manufacturers Teva Pharmaceuticals and Janssen Pharmaceuticals by patients who allegedly developed maculopathy and other eye disorders as a result of taking Elmiron. The lawsuits claim that the company was aware of Elmiron’s dangerous side effects but failed to warn consumers.
If you or a loved one were treated with Elmiron and developed maculopathy or other eye problems, contact Maxwell Law Group today. We can answer your questions and review your case for free.
What is Elmiron?
Elmiron (generic name: pentosan polysulfate sodium) is a medication given for the treatment of interstitial cystitis, a condition that causes bladder pain and pressure. Patients may experience a wide range of pain, from slight discomfort to debilitating pain. A normal bladder expands as it gets filled with urine. Once filled, it sends signals to the brain triggering the urge for urination. In interstitial cystitis, the signals get mixed up, resulting in frequent urination and pain in the pelvic area.
Elmiron received FDA approval in 1996. It is manufactured by Teva Pharmaceuticals and Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.
Elmiron Quick Facts
Medication for the treatment of interstitial cystitis
Maculopathy (retinal injuries)
Teva Pharmaceuticals and Janssen Pharmaceuticals
How Does Elmiron Work?
Although Elmiron’s exact mechanism of action is unknown, clinical models show that it binds with the bladder wall and possibly acts as a buffer to prevent irritating elements in the urine from reaching the cells.
Risks and Warnings
In 2019, Canada required Janssen to add a warning label to Elmiron regarding reports of maculopathy (retinal injuries) with continued use of the drug. Patients were advised to undergo regular ophthalmic examinations for early detection, especially for patients who have prolonged use of Elmiron.
Currently, there is no required warning label regarding Elmiron’s maculopathy risk in the United States. However, the FDA Adverse Event Reporting System (FAERS) issued last July to September 2019 lists Elmiron and its potential eye disorder risk. It also indicates that the FDA is evaluating the need for regulatory action.
Other risks include:
- Hair loss
- Headache and dizziness
- Skin rash
- Sleep disorders
- Abnormal liver function tests
Injuries from Elmiron
In November 2018, researchers from Emory Eye Center published a study that looked into the connection between maculopathy and chronic Elmiron use. The study concluded that non-Elmiron users did not have the specific form of pigmented maculopathy present in patients treated with Elmiron.
Another study by Kaiser Permanente eye doctors in October 2019 examined patients who took Elmiron for over 15 years. The researchers found that about 25% of patients with long-term use of Elmiron suffered from eye damage, specifically in the macula, the central part of the retina responsible for clear central vision.
In March 2020, a patient filed a lawsuit against manufacturers Teva Pharmaceuticals and Janssen Pharmaceuticals. The lawsuit claimed that the plaintiff developed permanent maculopathy after being treated for 6 years with Elmiron for interstitial cystitis. In addition, the lawsuit alleges that these companies knew about the link between Elmiron and eye damage risk but continued to market it as a safe medication.
How Maxwell Law Group Can Help
If you or a loved one were treated with Elmiron and developed maculopathy or other eye problems, Maxwell Law Group could help get you the compensation you deserve. Call (844) 525-7155 or fill out the form below, and we’ll investigate your case at no cost to you.
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