A popular drug used to treat interstitial cystitis is causing millions of Americans to have damaging vision problems, and even blindness. The drug’s name is Elmiron, and since March lawsuits have been filed against the makers for failure to warn consumers about potential injuries.
Here’s everything you need to know about Elmiron.
What is Elmiron and what is used for?
The drug was developed and marketed by Janssen Pharmaceuticals, Inc. (Janssen), a corporate subsidiary of Johnson & Johnson (J&J), beginning in 1996 when it was first approved by the Food and Drug Administration (FDA). Elmiron is one of only two drugs worldwide that are marketed and approved to treat discomfort caused by interstitial cystitis, a disorder affecting more than 12 million people in America. The leading drug is taken by users with chronic pain and discomfort in the abdomen, pelvic, and genital regions as well as increasing the urgency and frequency of bladder functions. Most Elmiron users are women and many have taken the drug for more than 10 years.
What side effects have been reported by Elmiron users?
The line of studies identifying Elmiron’s toxicity began between 2015 and 2017 when doctors from the Emory Eye Center in Atlanta, noticed a trend among six patients with abnormal damage to the macula region of their eyes. Patients were diagnosed with pigmentary maculopathy, a condition causing severe vision impairment, including blurred vision, extreme sensitivity to light and dark, and difficulty transitioning from natural light to indoors. Blindness may also occur as the disease progresses. All six patients were similarly found to be long-term users of Elmiron. As a result, the Emory Eye Center published a preliminary report in 2018 suggesting that Elmiron was toxic to the retinal tissue of the human eye, specifically, causing injury to the retinal pigment epithelium, a layer of cells that nourishes the retina.
Elmiron has been linked to causes of: areas of vision loss in the field of vision, difficulty adjusting to dim lighting or darkness, difficulty reading, difficulty seeing objects at close range, and vision dimming.
It’s reported that about 25 percent of patients who used Elmiron long-term displayed signs of maculopathy or significant eye damage, including blindness.
Is there a recall on Elmiron?
Elmiron has not been officially recalled despite studies linking long-term use of the IC drug to potentially permanent vision damage. In June 2020, Janssen added a warning to Elmiron’s label. As of September 2020, FDA has not mentioned plans to request that Janssen recall the drug.
What you should do now?
Many are taking action against Janssen by filing product liability lawsuits, alleging Janssen failed to warn users about potential vision issues.
If you or a loved one has experienced damaging vision problems since taking Elmiron, contact Tiano O’Dell, PLLC. Our West Virginia product liability attorneys are ready to take litigation action against Janssen.
Your Charleston-based law firm Tiano O’Dell, PLLC is accepting cases connected with Janssen’s popular but misleading drug, Elmiron. Call (304) 720-6700 today to discuss your case.