Vision & Eye Problems related to Elmiron

Elmiron®️ (Pentosan Polysulfate)

In October 2019, a warning and precautions were added to the Canadian Monograph for the drug Elmiron®️ (pentosan polysulfate sodium) relating to the use of the drug and serious eye and vision problems, including the possibility of Pigmentary Maculopathy which is permanent and irreversible without a chance for recovery. The more Elmiron taken, the greater increase in eye damage. Janssen Pharmaceuticals, the maker of Elmiron®️, has never updated their labeling for Elmiron or conducted further research concerning this associated risk despite the company knowing about the connection for over 20 years. The United States Monograph has yet to be updated. 

While this warning on the Canadian Monograph is very helpful for those patients who had been considering taking the drug, it does not provide relief or assistance to those who have already taken Elmiron and incurred the vision issues as a serious side effect that they were unaware existed. Contact our product liability attorneys if you feel that you or a loved one may have been affected. 

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What Is Elmiron®️ and What Is It Used for?

Elmiron®️ is a prescription drug used in the treatment of interstitial cystitis, also known as painful bladder syndrome. With this condition, patients endure discomfort and pain in the bladder as well as bladder pressure and pelvic pain. Interstitial cystitis causes the signals in the brain to become confused and the patient feels the need to urinate more often with smaller volumes than other people because the bladder is not yet full. 

The exact way that Elmiron®️ works is not completely understood, but in an effort to relieve the pain and discomfort from this bladder issue, Elmiron®️ is thought to adhere to the bladder mucosal lining, preventing potentially irritating solutes in the urine from reaching the bladder wall.

What Are the Side Effects of Elmiron®️?

Until very recently, only mild side effects related to the use of Elmiron®️ such as nausea, diarrhea, headache, or an increased risk for bleeding were reported by Janssen. However, the serious side effects related to eye damage and vision problems were never disclosed, even though Janssen had been aware of these potentially permanent injuries for more than 20 years. 

The potential side effects that have been recorded include:

  • Eye pain 
  • Difficulty seeing up close 
  • Blurred vision
  • Difficulty reading
  • Distorted vision
  • Trouble adjusting to darkness
  • Vision loss
  • Dark spots
  • Change in eye color
  • Hair loss 
  • Diarrhea 
  • Severe nausea 
  • Bloody stool 
  • Rash 
  • Bruising

Additionally, Elmiron®️ has also been linked to very serious conditions including: 

  • Macular degeneration 
  • Pigmentary maculopathy 
  • Retinal maculopathy
  • Retinal degeneration
  • Macular disease
  • Pigmentary retinopathy
  • Pigmentation macular degeneration
  • Pigmentation maculitis
  • Dry macular degeneration
  • Optic neuritis
  • Retinal hemorrhage
  • Retinal detachment 

Those patients who have taken Elmiron®️ and developed any of these vision impairments may be eligible to file a lawsuit against the drug’s manufacturers and fight for the compensation you deserve for your pain and suffering. Although Elmiron®️ is the only prescription medication available for interstitial cystitis, these severe side effects could warrant a recall by the manufacturer.

Elmiron®️ in the Pharmaceutical Market

Since the late 1990s, Elmiron®️ has been available as the only prescription medication treatment option for patients suffering from interstitial cystitis, and it has been distributed through Johnson & Johnson subsidiary Janssen Pharmaceuticals since 1996. Research has recently discovered that using Elmiron®️ in the long-term can result in the serious side effects listed above. Unfortunately, despite clear empirical evidence of the harm caused by the drug to its users, Elmiron has not yet been recalled by either the manufacturer or the Food and Drug Administration (FDA).

Drug recalls are an effective way to eliminate the potential for harm from a dangerous drug or other product to the larger public, but they are voluntary. Pharmaceutical companies are not required to recall any product from the market, and Elmiron®️ has not faced any such recalls. Even with substantial evidence pointing to severe eye and vision issues, Janssen Pharmaceuticals and the FDA have not alerted consumers to the risks they may face if prescribed Elmiron®️. 

Although Elmiron®️ is the only prescription medication treatment for painful bladder syndrome, the side effects to patients who take it could have prompted recall action to be taken by either the manufacturer or the FDA. Patients who have suffered from blindness or other painful eye conditions directly related to Elmiron deserve compensation for their injuries and should consult an experienced attorney to evaluate and handle their case.

Contact Carey Danis & Lowe for a Free Case Evaluation

At the law offices of Carey Danis & Lowe, our product liability attorneys have been representing individuals who have been injured by America’s largest corporations since 1995. Our firm has played a significant role in many high-profile class action and mass tort cases because we care about the victims in these cases. In the last decade, we have worked tirelessly for harmful drug and pharmaceutical liability clients and have obtained over $1 billion in verdicts and settlements. Our attorneys will continue to fight in state and federal courts for those injured by harmful drugs.

If you or a loved one has sustained injuries as a result of taking Elmiron®️ for painful bladder syndrome, our experienced lawyers at Carey Danis & Lowe can help. We are happy to provide you with a free case evaluation and determine if you might be eligible to fight for compensation, including coverage of medical expenses related to Elmiron®️, pain and suffering, loss of enjoyment, and punitive damages against the manufacturer. Contact us today to discuss your case.

(1.)  Jain N, Li AL, Yu Y, et al. Br J Ophthalmol/Epub doi:10.1136/bjophthalmol-2019-314765

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