Elmiron is prescribed for the treatment of interstitial cystitis, more commonly referred to as painful bladder syndrome. Elmiron, also known as pentosan polysulfate sodium, or PPS, is taken orally and was first approved by the U.S. Food and Drug Administration (FDA) in 1996. The drug was thought to ease bladder pain and discomfort by providing an extra coating of protection to the inner bladder walls, helping to mitigate painful irritation from urine in the patient’s bladder. Although men can develop interstitial cystitis, more than 90% of patients are female.
Long-term use of Elmiron has been linked to a rare but very serious eye condition called pigmentary maculopathy which is a type of macular degeneration of the eye. The condition was first discovered in early 2018 by a group of Ophthalmologists during a research study conducted by the Emory Eye Center in Atlanta. The disease was identified for the first time in 6 female patients whose only common trait was they were all taking Elmiron for interstitial cystitis.
Side Effects of Pigmentary Maculopathy
Pigmentary maculopathy is a gradual, progressive degenerative condition that first causes the loss of central vision or blind spots and can worsen into total blindness. Within the eye, Pigmentary maculopathy causes the pigmented cells underneath the retina to break down releasing pigment that winds up settling on the macula. The build up of pigment causes vision distortion and/or blurriness, difficulty adjusting to light and darkness and loss of vision. Other common injuries include:
- Dark spots
- Eye pain
- Distorted vision (metamorphopsia)
- Sensations of flashing lights
- Blurred vision
- Loss of color
- Difficulty adjusting after exposure to bright light
- Complete blindness
Litigation Against Elmiron Manufacturer J&J
Lawsuits have been filed alleging Elmiron manufacturer, Johnson & Johnson failed to warn about serious known health risks and side effects such as pigmentary maculopathy. The company’s failure to warn has put tens of thousands of patients at risk of harm due to the alleged misleading conduct of J&J.
Sad Dilemma for Painful Bladder Sufferers
Since first hitting the market in 1996, Elmiron has been the only medication available for patients suffering from interstitial cystitis which causes severe and debilitating pain in the bladder. As there is no known cure for the condition, patients are faced with living with severe pain or taking Elmiron which can cause total blindness. However, more recent studies raise the question of whether Elmiron has any positive benefits for treating the painful symptoms of interstitial cystitis.
Elmiron’s Sketchy Clinical Trial and Development History
When Elmiron was first developed in the mid 1980’s the FDA granted “orphan drug” designation because it was thought to be the only viable treatment of the rare condition Interstitial Cystitis. Elmiron was one of the first medications to receive orphan drug status after the Orphan Drug Act as was passed in 1983. Because this condition is so painful for patients, the FDA allowed the drug to be prescribed based on a “compassionate use” study rather than facing the more rigorous clinical trial testing typically required for drug approval.
Based on mounting evidence that Johnson & Johnson knew early on that the risks associated with taking Elmiron were much more extensive than what they disclosed to patients and their doctors, a class action lawsuit has been filed on behalf of victims suffering from eye injuries related taking Elmiron.
You may have a claim for damages against Elmiron manufacturer Johnson & Johnson
If you or a loved one took Elmiron and developed retinal related vision problems such as macular degeneration or pigmentary maculaopathy, you may qualify to join a class action lawsuit that has been filed. Case Works is not a law firm, but we work with some of the best attorneys in the nation and can get you connected with one of them to evaluate your case. Click the link below to get in touch with us.