Elmiron

If you or a loved one has taken Elmiron (also known as pentosan polysulfate sodium, or PPS), you may be entitled to financial compensation.

Elmiron is a medicine that many doctors (including urologists, gynecologists, internists and general practice doctors) have prescribed since 1996 for patients who suffer from painful bladder syndrome  (interstitial cystitis). Many patients had been and still are taking the medication several times a day, as their prescribing physicians have not been told by Elmiron’s manufacturer of the dangers Elmiron poses, especially after prolonged use.

Recent studies at Emory University’s Medical School’s Eye Center and at Harvard Medical School have closely linked Elmiron to serious eye disorders and vision problems  — disorders the manufacturer appears to have been aware of for a long time but hid from doctors, regualtors and the public. Elmiron is thought to cause a unique and rare eye disease called retinal maculopathy, where the pigment cells located in the eye’s retina change colors, and forms tiny subsurface abnormalities in the eye, wreaking havoc on the visual system. Common symptoms of retinal maculopathy include

  • Blurred / Worsened Vision
  • Difficulty reading
  • Difficulty adapting to dim lighting
  • Dark spots in center of vision
  • Blindness
  • Straight line distortion

Because many of these symptoms are very similar to those of another eye disorder called “macular degeneration” it’s likely that some patients who took Elmiron were told (or thought they were told) they were suffering from macular degeneration, retinal pigmentary endothelium injury, or pattern dystrophy, when in fact they may have been misdiagnosed or misunderstood their eye doctor and are victims of retinal maculopathy – the signature disease caused by Elmiron.

Elmiron began facing scrutiny after Emory Eye Center Ophthalmologists noticed a serious new eye disease developing in patients. Further research revealed that all of these patients had one thing in common – they had been taking Elmiron. Following this shocking revelation, several medical studies were initiated with the aim to determine whether Elmiron could be at fault for these harmful complications. Unfortunately, a myriad of these studies, including those run by JAMA Ophthalmology and the Journal of Urology, have all confirmed that exposure to Elmiron can result in vision-threatening eye problems.

The scope of this problem is potentially breathtaking; a survey run by the IC network (a large advocacy group for patients suffering from interstitial cystitis) revealed that 53.87% of the patients who took Elmiron developed retinal disease.

Finally, in September 2019, the U.S. Food and Drug Administration (FDA) took action to warn consumers by adding “eye disorders” linked to Elmiron to its list of New Safety Information, The FDA also is “evaluating the need for regulatory action” that world force a change in Elmiron’s labeling, the drug’s side effects notice and warning label still contains no warnings of eye complications – keeping patients everywhere at serious risk. Nor has Elmiron’s manufacturer, Janssen Pharmaceuticals, a unit of Johnson and Johnson, taken any steps to withdraw the drug from the market or even acknowledge the potential for serious eye and vision-related complications. This irresponsible lack of action is made more upsetting because in its own early clinical trials of the drug Janssen Pharmaceuticals found Elmiron related to eye complications – including optic neuritis and retinal hemorrhage. Janssen Pharmaceuticals and Johnson & Johnson knew for decades that Elmiron posed risks but buried the danger and failed to issue the appropriate warning. Instead of adding these complications to the drug’s warning label or conducting further research into the link between Elmiron and visual damage, Janssen Pharmaceuticals chose to stay silent and make billions from selling what is a dangerous drug, harming countless patients across the world in the process. Because Elmiron’s manufacturer knew of the dangers the drug posed but failed to disclose them, we are also preparing to seek potential punitive and exemplary damages for our Elmiron clients.

How We Can Help

The highly experienced lawyers at Advocate Law Group P.C., working with members of the Advocate Law Group Network are here to help hold manufacturers like Johnson & Johnson’s Janssen Pharmaceuticals fully accountable for their harmful and irresponsible actions. Our legal team has worked on many similar cases in the past and achieved major recoveries for consumers harmed by harmful drugs and defective medical devices. Justice is just a phone call away.

If you have taken Elmiron and developed visual problems, reach out to us, toll free at 1-888-ITS LEGAL (1-888-487-5342) for a free, no obligation consultation.