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Janssen Pharmaceuticals is alleged to have known about, but not timely disclosed life-changing injuries resulting from its Elmir

Close up of a human eye

The only drug available to treat interstitial cystitis has a dirty secret. According to several studies and an article by Forbes, the long-term use of Elmiron has been linked to retinal damage and toxicity as well as vision injuries and even vision loss. The claims and lawsuits to date largely allege that the provider of Elmiron®, Janssen Pharmaceuticals, knew of these problems, but did not timely warn or take action. Finally, in June 2020, Janssen did update the drug’s label to warn of potential vision problems. While this new information may help those patients who are prescribed Elmiron® in the future, it is too late for way too many.

What Is Interstitial Cystitis?

Also referred to as “painful bladder syndrome,” interstitial cystitis (IC) is a chronic condition causing pressure and pain in the bladder. Sometimes, it causes pelvic pain, as well.

Symptoms of IC include:

  • Pain in the pelvis between the vagina and anus (in women)
  • Pain between the scrotum and anus (in men)
  • Chronic pelvic pain
  • A persistent, urgent need to urinate
  • Frequent urination (up to 60 times a day)
  • Pain or discomfort while the bladder fills
  • Pain during sexual intercourse

Some people with IC feel like they have a permanent urinary tract infection (UTI) – even when no infection exists. There is no known cure for interstitial cystitis, so patients depend on medication and therapy to help with symptoms.

What Is Elmiron®?

Elmiron®, or pentosan polysulfate sodium (PPS), is the only FDA-approved medication for the treatment of interstitial cystitis. The drug works by forming a protective coating on the inner lining of the bladder.

Like any medication, Elmiron® has side effects. Nevertheless, Janssen Pharmaceuticals (Elmiron®’s manufacturer) is alleged to have failed to timely disclose one of the drug’s more serious consequences.

A Shocking Discovery

An eye doctor in Atlanta, Georgia uncovered what appears to be Elmiron®’s most insidious side effect when patients who had been taking the drug for years developed unusual changes in their macula (eyes). Because the macula is the central part of the retina and responsible for delivering clear central vision, many of these patients had trouble reading in dim light and seeing clearly, especially at night. The Emory Eye Center doctor examined patients’ medical histories and performed genetic testing. Seeing no evidence of genetic abnormalities and the common factor of long-term Elmiron® use in all patients, the doctor issued an alert.

From there, ophthalmologists at Kaiser Permanente discovered a woman who was misdiagnosed as having retinal dystrophy. Upon examining its patient databases, Kaiser Permanente found 140 patients who had taken Elmiron – 91 of which agreed to participate in a study.

Researchers at Kaiser discovered that 22 of the 91 patients (about 25%) showed clear signs of drug toxicity. Left unchecked and untreated, this toxic maculopathy can lead to permanent vision loss.

What To Do if You Take Elmiron®

If you take Elmiron®, see your eye doctor as soon as possible to discuss your concerns and know that some researchers recommend you schedule screenings for retinal damage at least once a year. If you show damage, you should speak to your urologist or OB/GYN about discontinuing the medication. Of course, you should also speak with your eye doctor.

Maculopathy is one of the leading causes of blindness. If you’ve been diagnosed with toxic maculopathy after long-term Elmiron® use, Brett H. Oppenheimer, PLLC may be able to help.

Call Brett at (502) 242-8877 or contact our firm online for a free, confidential consultation.

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