Recent studies have suggested that long-term use of Elmiron can cause maculopathy, an eye disorder that can lead to blindness. Doctors studying the drug have identified numerous patients with pigmentary maculapothy that those patients developed after taking Elmiron. The American Academy of Opthamology reports that doctors studying the drug recommend eye imaging for patients currently on Elmiron to determine whether maculopathy is present and discontinuation of the drug if maculopathy is found.
Patients who have taken Elmiron are now suing the manufacturer of the drug, Janssen Pharmaceuticals. Patients accuse Janssen of failing to warn patients about the full dangers of taking the drug, including the risk of maculopathy and blindness. If you or a loved one took Elmiron and then developed maculopathy, filing a lawsuit may help you pay for medical bills, lost wages, and other costs associated with your suffering. Lawsuits can also help send a strong message to big pharmaceutical companies that they should fully test their products for safety before selling them to the public.
Elmiron (pentosan polysulfate sodium) is a drug commonly prescribed to treat interstital cystitis, a bladder disorder. Interstitial cystisis is part of a group of diseases referred to as "painful bladder syndrome" or bladder pain syndrome. Untreated, interstitial cystitis can cause bladder pressure and bladder and pelvic pain that can range from moderate to severe. The disorder most frequently affects women and can lead to the sensation of needing to go to the bathroom more often.
Though doctors are not sure exactly how Elmiron interacts with the body, Elmiron is believed to work by attaching itself to the wall of the bladder and providing a buffer to irritating substances. In this way, the drug may decrease bladder pressure and pain.
Elmiron is currently the only FDA approved drug to treat interstitial cystitis and/or bladder pain syndrome. Though the patent expired on Elmiron in 2010, the lack of substitute drugs means that many patients pay thousands of dollars out of pocket for the medication. Janssen Pharmaceuticals, a division of Johnson & Johnson and the current manufacturer and marketer of Elmiron, has not offered an explanation for the increasing prices of Elmiron. Nevertheless, Janssen stands to make increasing profits on Elmiron as the market for interstitial cystitis treatment is increasing.
Elmiron, which is manufactured by Janssen Pharmaceuticals, was approved by the FDA to treat bladder pain and discomfort associated with interstitial cystitis.
Elmiron has come under scrutiny after studies have linked it to vision problems, described as a type of pigmentary maculopathy, but which sometimes may be diagnosed as macular degeneration or macular or pattern dystrophy. The macula is responsible for central and detailed vision.
A study in JAMA Ophthalmology found that patients with exposure to PPS experienced metamorphopsia, in which straight lines may appear wavy, blurred vision, and prolonged dark adaptation. A similar study published in the Journal of Urology identified the most common symptoms of PPS-related ocular problems as difficulty reading and adapting to dim lighting. Authors of studies discussing these PPS-related eye problems have described PPS-related ocular toxicity as “vision-threatening.”
Elmiron has no warnings regarding eye problems in its labeling and there are now several dozen adverse events related to eye disorders and vision problems similar to those discussed in the medical literature that have been reported in the FDA’s FAERS database.
Symptoms for patients experiencing Elmiron-associated eye damage include:
While the medical community has only recently learned of this connection, Elmiron’s manufacturer Janssen has known of the link between Elmiron and eye damage for over 20 years. In early clinical trials of patients who took Elmiron for up to four years, both vision and eye related adverse events were reported.
Although Janssen knew of the link between Elmiron and eye damage for more than 20 years, the company never added warnings to the label or conducted further research on the link between Elmiron and eye damage. Instead, they ignored the risks and went on to earn billions of dollars selling Elmiron. Now they will face thousands of lawsuits from patients that suffered severe eye damage. If you have taken Elmiron and experienced eye damage, contact us today.
Drug manufacturers are responsible for ensuring the safety and efficacy of their products before marketing them for public consumption. Failure to do so is considered negligent and grounds for litigation. The attorneys at Ennis & Ennis, P.A. handle litigation across the United States for victims injured by defective pharmaceuticals and medical devices. If you believe that you may have suffered vision loss or have been diagnosed with macular degeneration or a similar condition, please call us today at 1-800-856-6405 or email us at Holly@ennislaw.com so that we may provide you with addition information about your legal rights.