Have you or a loved one taken oral prescription drug Elmiron for urinary pain — and then suffered serious vision problems, or even blindness? If so, you took Elmiron with lack of warnings about its dangerous side effects. Such negligence by the drug’s maker means you may qualify for an Elmiron lawsuit claiming payments for your losses.
Longtime Elmiron Use is Risky
The fact is, longtime use of Elmiron to treat urinary pain caused by interstitial cystitis can be extremely risky. And Americans have been using Elmiron for a long time — since it was first approved by the U.S. Food and Drug Administration back in 1985.
Marketed and sold in the United States by Belgium’s Janssen Pharmaceuticals, Inc., which is owned by American pharmaceutical giant Johnson & Johnson, Elmiron was first FDA-approved to treat interstitial cystitis.
What is interstitial cystitis?
Also known as IC or “painful bladder syndrome,” it’is a chronic ailment which leads to bladder and pelvic pressure and pain — pain which can be so severe that it becomes debilitating. Interstitial cystitis is believed to be suffered by up to one million Americans, most of whom are female.
But they can’t take Elmiron to treat their pain and then stop. Rather, they must continue to take the drug long-term to keep fending off the bladder and pelvic pain they suffer. For many Elmiron users, that means taking the drug for many years. It is this very long-term Elmiron use which makes the drug especially dangerous. Even if you’ve taken Elmiron for only six months, if you then suffered vision loss or blindness it may be due to this defective drug. And you could be entitled to substantial financial rewards for your injury via an Elmiron lawsuit.
Elmiron Vision Loss
Studies presented to the American Academy of Ophthalmology have shown that as many as one-fourth of long-term users of Elmiron may have suffered ocular damage which can cause vision loss or blindness. Researchers found that a higher risk of vision loss and ultimately blindness was associated with long-term Elmiron use.
Their research was based on medical claims from 2002-2016 by persons who’d used Elmiron for a prolonged period of time. These persons then showed signs of ocular toxicity and eye damage. Some Elmiron vision loss victims at first may be diagnosed with other vision disorders, such as pattern dystrophy or macular degeneration. But a closer inspection can reveal that their vision loss is related to their sustained, long-term use of Elmiron.
According to the FDA’s Adverse Event Reporting System (FAERS), 100 cases found to be eye disorders among Elmiron users were identified and filed with the FDA between 1997 and 2019. Of those 100 cases, 80 were classified as serious, and more than 20 of such reports noted some type of maculopathy.
What is Maculopathy?
As for what is maculopathy, that condition refers to the macula, which is a layer of tissue located at the rear of the eye but in front of the central part of the light-sensitive retina. Macula damage can lead to loss of visual acuity and, given enough time, even blindness.
Also known as macular degeneration, maculopathy produces symptoms incuding gradual loss of central vision (as opposed to lateral, or side vision) for one or both eyes. The condition is painless, and it may not lead to substantial vision loss for some time, especially if it involves one eye, and the other eye compensates. Progression of macular degeneration can be rapid, or it can take several years.
A more specific vision problem known as pigmentary maculopathy is the disorder which seems to be affecting Elmiron users the most. In fact, it may be unique to such patients. This means the victim may develop pigmented spots of the retina, or excessive capillaries. A physician at the Emory Eye Center in Atlanta, GA reported in 2019 that over the previous four years, 10 patients experienced pigmentary maculopathy which had no apparent cause. But a cause was suggested by the fact that each of these 10 patients had taken Elmiron.
Elmiron Label Lacks Warnings
Though such vision problems related to Elmiron usage have been known for years, the drug’s maker has not included on its Elmiron label any language noting pigmentary maculopathy or any other type of maculopathy. Yet the drug’s maker appears to have known of Elmiron eye problems for years.
Evidence indicates that research into potential eye damage caused by Elmiron began at least in 2018, if not earlier. Yet up to today, no warnings for macular damage, visual changes or other eye conditions have been listed on the prescribing information for Elmiron. Further, the label for Elmiron products has no relevant warnings about vision loss, and it does not identify any relevant adverse vision events which have been observed post-marketing.
Indeed, the sole indication that Elmiron use could be associated with ocular or vision-related disorders is in the “adverse reactions” section of the labeling. This refers to optic neuritis, retinal hemorrhage, nystagmus, amblyopia and conjunctivitis observed during premarket clinical trials of the drug. But there’s no mention of pigmentary maculopathy or another type of maculopathy which tend to afflict Elmiron users.
Get Elmiron Attorneys to Help
If someone in your family suffered such vision loss after taking Elmiron for six months or more, you need to get Elmiron attorneys to help you with your legal case.
To do so, contact us at the Willis Law Firm for a free legal review of your case. We’ll provide Elmiron attorneys to help you determine your chances for a successful Elmiron vision loss lawsuit. Then you can decide how you want to proceed. Find out what legal rights you may have for damages in a Elmiron vision loss lawsuit.