The prescription drug Elmiron (pentosan polysulfate sodium) is a weak blood thinner and bladder protectant that is used to treat the discomfort of cystitis and bladder pain. Recently, studies indicate that Elmiron may cause serious eye damage in some patients. Elmiron lawsuits claim that the drug causes maculopathy and other disorders of the retina. These disorders can ultimately lead to blindness.
If you took Elmiron and suffered serious vision problems, you may be eligible to file an Elmiron lawsuit. At Coxwell & Associates, PLLC, our Elmiron injury lawyers are helping victims explore their legal options. Our lawyers can examine your case and help you learn more about your legal options. We charge no fees unless we are successful in obtaining a settlement for you.Elmiron: The Facts
Although Elmiron does not “cure” Interstitial Cystitis or bladder pain syndrome, it has been found to offer some relief. IC is a common condition that affects more than one million men each year and from 3-8 million women in the U.S. each year. There is currently no cure for interstitial cystitis. Researchers are unclear about the causes of Interstitial Cystitis (IC), although certain foods or drinks could trigger symptoms among some.
The normal recommended dosage of Elmiron is 300 mg per day, usually taken as one 100 mg capsule three times per day. According to the manufacturer of Elmiron, the drug can adversely interact with a variety of drugs, including NSAIDs, Aspirin, Alteplase, Anistreplase, Clopidogrel, Streptokinase, Ticlopidine, Urokinase, or Dipyridamole.
It is unknown whether Elmiron passes into breastmilk, so is not recommended for women who are breastfeeding. Unfortunately, as with many prescription drugs, there are serious side effects for those taking Elmiron for regional bladder or pelvic pain. Since Elmiron is currently the only FDA approved drug for these issues, the company essentially has an exclusive market, with a drug that could be adversely affecting millions of women and men.When Did Elmiron Receive FDA Approval?
Janssen Pharmaceuticals originally had Elmiron approved in 1996 by the FDA under the “Orphan Drug Act.” This Act is for drugs that treat rare diseases and for which there are no other drugs currently approved for the disease. Special incentives and status are given under the Orphan Drug Act to manufacturers of these medications. Elmiron received “regular” FDA approval in 2001, only for use in regional bladder or pelvic pain.
The manufacturers of Elmiron tested the drug in 2 clinical trials, with 2,627 patients. Of those, 2,343 were women, 262 were men, and 22 were unknown. After three months in the second trial, more than half of the participants had dropped out of the study. It was found that Elmiron did relieve pain from IC among many of the study participants, usually within three months. A small percentage of the participants took up to six months to notice any pain relief at all. An independent study done on a smaller number of patients, and published in The Journal of Urology, found that Elmiron offered few benefits to most IC patients.Side Effects Noted During Clinical Trials
There were a significant number of side-effects noted during the clinical trials, with six patients dying during the study. The consensus was that “other health problems” were the cause of the deaths, rather than Elmiron. The most common side effects (hair loss, diarrhea, nausea, headache, upset stomach, rash, abdominal pain, dizziness, and abnormal liver function) occurred in one to 4 percent of study participants, while very serious side effects occurred in 33 of the participants. Since almost half of the study participants dropped out, 33 is a significant number. Elmiron’s insert also mentions weight gain and edema as potential side effects, and in a phase 4 study of 128 patients, 6.3 percent of those participants experienced rectal hemorrhage (though most described it as “mild”).Post marketing Data and FDA Adverse Event Reporting System
Between 1997 and December 31, 2019, there were 2,460 adverse event reports turned in to the FDA over the prescription drug, Elmiron. Of those 2,460 adverse event reports, 1,691 were serious, with 23 deaths. The FDA was unable to verify if the deaths were directly related to Elmiron.
Many of the adverse event reports sent to the FDA regarding Elmiron were about vision problems. It appears Elmiron can cause retinal damage which changes the macula of the eye (the central part of the retina that is responsible for delivering crisp, clear, central vision. This retinal damage may be misdiagnosed as age-related degeneration maculopathy among older patients, although researchers have found that lesions on the scans are more centralized in pigmentary maculopathy which gives Elmiron a “signature” injury.”Can Elmiron Cause Permanent Eye Damage?
Research has linked the drug Elmiron with a unique form of progressive eye disease. This progressive eye disease is usually diagnosed by ophthalmologists as retinal pigmentary maculopathy, or age-related macular degeneration. Those who experience Elmiron-associated eye disease may have the following symptoms:
- Problems adapting to dim lighting;
- Difficulty reading;
- Blurry vision, often in the central field of view;
- Dark spots in the central field of view;
- Seeing colors as much less vivid, or
- Straight lines that occur squiggly or curved.
Ophthalmologists in Atlanta, Georgia witnessed an entirely new eye disease in six of their patients, found using advanced retinal imaging. This new eye disease was called “retinal maculopathy,” which means the pigment cells within the retina of the eyes changed color, leading to significant vision and eye dysfunction, like the effects seen in elderly patients who have been diagnosed with age-related macular degeneration. All six of the patients were women, and, after an exhaustive review of each woman’s medical records, it was found all six were taking Elmiron for IC. This study was published in 2018 in the Journal of Ophthalmology.Could You Benefit from Legal Assistance After Taking Elmiron?
Although there is currently no warning on U.S. Elmiron labels, Canada changed its label to add a warning in October 2019. Elmiron is currently a Teva brand, under license to Janssen, with more than $150 million in sales. Since Elmiron is not generic, there are no preemption issues. Our law firm is currently in the process of evaluating Elmiron cases for filing.
If you or someone you love has suffered eye damage after taking the drug Elmiron, it is important to speak to one of our injury attorneys immediately to protect your rights. At Coxwell Law & Associates, we are currently investigating Elmiron cases. Our lawyers believe in holding negligent pharmaceutical companies accountable for producing and marketing dangerous drugs to the public. If you have been diagnosed with eye damage, such as retinal pigmentary maculopathy, or age-related macular degeneration after taking Elmiron, we can help. Contact the skilled team at Coxwell & Associates, PLLC at (877) 231-1600 for a free initial consultation and review of your case. We can help you review your legal options and get you the compensation you need.