Elmiron Recall 2020 Update

Elmiron is a brand name drug used to treat bladder pain caused by a health condition known as interstitial cystitis. Pentosan polysulfate sodium is the generic equivalent of Elmiron. Some people also refer to interstitial cystitis as painful bladder syndrome.

The Food and Drug Administration (FDA) labeled Elmiron an orphan drug when approving its use because it originally considered interstitial cystitis a rare condition. Orphan drugs refer to a medication being the only drug available to treat certain conditions or one of only a few available drugs. Drug manufacturers often have extra financial incentive to create orphan drugs, which can lead to a rush to get them to market. Since FDA approval of Elmiron, more than one million Americans have received a diagnosis of interstitial cystitis.

The issue of serious Elmiron side effects first came to light in May 2018. Dr. William Pearce and several of his colleagues at Emory Eye Center published the results of a small study involving six adults who took Pentosan polysulfate sodium to treat interstitial cystitis. The study results showed that chronic exposure to the drug caused pigmentary maculopathy, which is an injury to the epithelium pigment of the eye’s retina. These are the cells that provide the retina with nourishment. Several additional studies since that time have drawn the same conclusion.

Plaintiffs are now suing Janssen Pharmaceuticals, the makers of Elmiron, because they state that the drug manufacturer’s packet of information about side effects included nothing about eye disease. The most common eye disorder associated with long-term use of Elmiron is maculopathy. It can lead to blindness in severe cases.

Follow-Up Study by Doctors from the American Academy of Ophthalmology

Dr. Ronald Melles, Dr. Amar Patel, and Dr. Robin Vora are three physicians who discovered signs of toxicity with a larger group of patients who had taken Elmiron. After presenting their findings at the American Academy of Ophthalmology in late 2019, the doctors released results of a study with 117 ophthalmology patients in January 2020.

Melles, Patel, and Vora believe that their study results draw a positive link between long-term use of Elmiron and the development of toxic maculopathy and other serious eye conditions. Approved by the Food and Drug Administration (FDA) in the 1990s, Elmiron is currently the only prescription drug available to treat interstitial cystitis.

Understanding Maculopathy

The retina of the eye senses incoming light and sends a signal to the brain for processing. The term macula describes the back of the retina. Damage to the retina causes vision problems, up to and including blindness. Maculopathy is currently the leading cause of blindness in Western nations. Some people who used Elmiron have developed a sub-type of maculopathy known as pigmentary maculopathy. This condition appears to be unique to long-term use of Elmiron according to the research studies released on it so far.

Eye damage caused by Elmiron appears to be minimal when people taking the drug discontinue its use immediately after discovering a problem. Unfortunately, pigmentary maculopathy caused by long-term use of Elmiron can cause mild to severe vision loss and other permanent eye damage. People who have filed an Elmiron lawsuit have stated that the first and most common side effects are an inability to adjust to dim lighting and difficulty reading. Other side visual side effects associated with Elmiron include:

  • Difficulty seeing objects in close proximity
  • Dimming of vision
  • Paracentral scotoma, which describes absolute or relative vision loss within 10 feet of the fixation point of the eyes

In the studies published by Melles, Patel, and Vora, people who took Elmiron at a strength of 1,500 g or higher had the greatest risk of developing toxic maculopathy. You may be eligible to file a personal injury lawsuit or join a class-action lawsuit against Janssen Pharmaceuticals if you took Elmiron to treat interstitial cystitis for at least two years. Your vision problems must have started while taking Elmiron or within one year of discontinuing it.

Common Injuries Caused by Long-Term Use of Elmiron

People who have already filed an Elmiron lawsuit have reported these eye conditions:

  • Full or partial vision loss
  • Impaired vision
  • Blurred vision
  • Bilateral blindness
  • Unilateral blindness
  • Degenerative maculopathy
  • Scotoma
  • Retinopathy
  • Halo vision
  • Reduced vision at night
  • Macular degeneration
  • Macular or pattern dystrophy
  • Retinal pigment epithelium atrophy
  • Metamorphopsia
  • Pigmentary maculopathy

Has Elmiron Been Recalled Yet By FDA?

Elmiron is still on the market as of late 2020. This is despite the fact that research surfaced as early as 2018 indicating a clear link between long-term use of Elmiron and macular degeneration, retinal maculopathy, pigmentary maculopathy, pattern dystrophy, vision loss, and other vision problems. The FDA has recently released details on a change of label for Elmiron. This label update now mentions pigmentary maculopathy in the “Warnings” and “Adverse Reactions” sections. In addition to this, the FDA is recommending periodic eye exams for consumers starting Elmiron.