After over a year of controversy, U.S. health officials finally added warning labels to the medication Elmiron about the risk of vision loss and potential blindness. Recent studies have found that the popular prescription drug increases users’ likelihood of developing a rare retinal disease known as pigmentary maculopathy.

On June 16, the U.S. Food and Drug Administration posted a new warning label about Elmiron increasing user’s risk of developing a rare eye disease that can lead to blindness. Elmiron (pentosan polysulfate sodium or PPS) has been used for decades to treat interstitial cystitis or “painful bladder syndrome.”

Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, first introduced Elmiron to the market in 1996 to treat interstitial cystitis. Because it is a chronic condition with no cure, those diagnosed with painful bladder syndrome often have to stay on treatment for years, sometimes decades.

However, over the past year case report and studies have linked Elmiron to a side effect called pigmentary maculopathy. This disease may cause severe side effects including blurry vision, dark spots, vision loss, and prolonged adaptation to dim light.

“Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use,” the warning shows. “While the etiology is unclear, cumulative dose appears to be a risk factor.”

The new warning label also recommends for healthcare professionals to use extreme caution in diagnosing patients with previous retinal pigmentary changes. The FDA recommends for doctors to get a detailed ophthalmologic history before starting them on Elmiron treatment.

Experts anticipate hundreds, perhaps thousands, of Elmiron lawsuits over vision loss in the upcoming moths as Elmiron users find their vision injuries were caused by the dangerous side effects of the drug.

Elmiron Side Effects Lawsuits

If you were diagnosed with vision loss or injury after using Elmiron, you may be entitled to compensation from Janssen Pharmaceuticals for their negligence. Manufacturers of medications have a duty to protect users and ensure their products are safe. If you are harmed by an unreasonably dangerous product without proper warning being given, the manufacturer is responsible for your injuries.

At AVA Law Group, our attorneys battle negligent manufacturers in court to ensure you get just compensation for your Elmiron side effects. We cut through the legal red tape so you can focus on healing and recovery. For your free, no-obligation case evaluation, contact us today at 1.800.777.4141; we have caring representatives standing by 24/7 to answer your questions and concerns.