People rely on prescription medications to be safe. When medications like Elmiron are not safe, the people who are injured may be entitled to compensation. Boston product liability attorney Michael O. Smith and his team of attorneys at Mass Injury Group can provide legal guidance and advice to the victims of medications like Elmiron.

Elmiron, the brand name of pentosan polysulfate sodium (“PPS”), is a medication prescribed to treat symptoms of interstitial cystitis. Interstitial cystitis causes pressure and pain in the bladder. It is a chronic condition without a cure. The FDA approved Elmiron in 1996 and there is currently no generic equivalent. As the only oral drug approved by the FDA to treat the bladder discomfort and pain associated with interstitial cystitis, Elmiron has been widely used in interstitial cystitis patients, often long term and in large doses. While Elmiron may have provided relief to many people, serious concerns have arisen about the drug’s safety in recent years.

In 2018, three doctors published a paper linking pigmentary maculopathy to chronic exposure to PPS. Additional studies have supported this finding. Maculopathy is a condition or disease of the part of the retina known as the macula. Pigmentary maculopathy involves changes in the retinal pigment epithelium. Patients report blurry vision, difficulty reading, and taking longer to adjust to low levels of light.

Janssen Pharmaceuticals, Inc., the manufacturer of Elmiron, did not include a warning regarding maculopathy until very recently. In 2020, the FDA approved a new label which added a warning about retinal pigmentary changes. The warning states that most cases occur after 3 years or more of use, but some cases have occurred in a shorter timeframe. The warning recommends an ophthalmologic history be taken for all patients and a comprehensive baseline retinal exam be taken for patients who have pre-existing eye conditions before they start taking Elmiron. It also recommends periodic retinal exams during treatment. “Pigmentary changes in the retina” has been added as an adverse reaction. The drug label was revised again in March 2021.

Although Elmiron now includes a warning regarding maculopathy, it was on the market for more than 20 years without such a warning. Many, many people took this medication without knowing the potential risk for eye damage. The Medication Guide in the most recent version of Elrimon’s drug label states that the pigment changes in the retina may continue even after a person stops taking Elmiron. It is unknown how many people may now be suffering from eye damage or vision loss without knowing the cause or how many people could be affected in the future.

Drug manufacturers should ensure their products are properly tested, manufactured and distributed. Additionally, they should provide instructions on use and warnings of any potential side effects. Manufacturers of unsafe drugs should be held responsible for the damage they cause. If you have been diagnosed with maculopathy after taking Elmiron, you deserve to be compensated for your injuries. Vision damage can significantly affect a person’s life. The damages that can be recovered will depend on the facts of each case but may include: medical expenses, pain and suffering, lost wages, and lost earning potential.

Anyone who has developed eye or vision problems following use of Elmiron should consider discussing pigmentary maculopathy with a health care professional. It is sometimes misdiagnosed as other eye conditions. If you have been diagnosed with maculopathy after taking Elmiron, you should speak with a skilled Boston Elmiron maculopathy lawyer about your case. Attorney Michael O. Smith and Mass Injury Group can inform you of your legal options and advise you on your case. We are dedicated to serving clients in Boston and nearby areas. Your case will be handled on a contingency-fee basis, and the initial consultation is free. Contact us online or call (617) 263-0060 to schedule your consultation.