Elmiron is used to relieve the irritation and pain caused by interstitial cystitis. The medication does not work like any other pain relievers or anti-inflammatories and does not have any generic counterpart.
This product is manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, and has been in the market since 1996. However, Elmiron made headlines when vision impairments were linked to its use without any warnings.
Interstitial cystitis is more commonly known as painful bladder syndrome. Until now, researchers have not yet discovered any cure. Symptoms include pelvic and abdominal pain and pressure, urinary urgency (the feeling of having to urinate even after urinating), frequent urination, and incontinence (involuntary urination).
This condition is more prone to women, but men and children can develop this as well. The pain of having interstitial cystitis can range from mild to severe, with some experiencing pain more frequently than others. To relieve discomfort, doctors may prescribe Elmiron, antihistamines, nonsteroidal anti-inflammatories, or tricyclic antidepressants.
The cause of interstitial cystitis is still unknown. Most of the time, a person with interstitial cystitis is not diagnosed right away because of the symptoms that are similar to other disorders. These disorders include urinary tract infection, chronic pelvic pain syndrome, chronic prostatitis, endometriosis, and bladder cancer.
Elmiron’s Side Effects
Elmiron, the drug that relieves the pain of interstitial cystitis, also carries some side effects. These common side effects include abdominal pain, abnormal liver function test, blood in the stool, bruising, diarrhea, dizziness, headache, hair loss, nausea, rash, and upset stomach.
According to clinical trials, most of the side effects suffered by the participants were minor. Only thirty-three trial participants out of 2,627 endured severe side effects. It was also found out that there are more or less 97% of Elmiron users who experienced hair loss.
The side effects listed above are visible on Elmiron’s warning label. But, the risk of having vision impairment, such as pigmentary maculopathy, was not, in any way, mentioned. This year, Janssen Pharmaceuticals decided to add vision side effects in the US market due to the pressure from researchers and the public. The same warning has been added to the Canadian version of the medication way back in October 2019.
In 2018, several studies linking Elmiron to vision impairments were produced by researchers. As published in the Journal of Urology, Dr. William A. Pearce and his colleagues asserted that long term use of Elmiron develops “injury in the retina and the underlying retinal pigment epithelium.” The statement was a result of their case study involving six adult patients using Elmiron for interstitial cystitis.
In 2019, further studies were made by the doctors at Emory Eye Center. As a result of observing ten patients with a history of interstitial cystitis, the researchers mentioned that those who did not take Elmiron did not develop pigmentary maculopathy or any form of visual damage. The doctors recommended an eye examination for everyone using Elmiron.
Furthermore, those who developed any vision impairment are advised to refrain from using the drug. Since then, more and more studies have emerged that links Elmiron to vision impairments, especially pigmentary maculopathy.
Lawsuits for Vision Impairment
Despite studies published by esteemed doctors and scientists since 2018, it took a long time for Janssen Pharmaceuticals to add vision side effects to Elmiron’s warnings in the US. Several lawsuits have been filed against the use of Elmiron. The Food and Drug Administration already warned the public of its use and started its investigation regarding the matter.
Below are some of the patients who filed cases against Janssen Pharmaceuticals, the subsidiary of Johnson & Johnson, and the manufacturer of Elmiron.
On May 4, 2020, an Elmiron lawsuit was filed by Tina Pisco. Pisco claimed that the use of Elmiron was the main reason she developed maculopathy. Ever since she took Elmiron in 2012, her vision began to deplete.
Furthermore, in 2019, Pisco was diagnosed with permanent retinal injury in both her eyes. Pisco alleged that Janssen Pharmaceuticals withheld vital information regarding the risks of having visual damage by taking Elmiron. Visual side effects, such as conjunctivitis, optic neuritis, amblyopia, and retinal hemorrhage, were only classified under the 1% category listed in the leaflets and official website.
Valerie Hull decided to file a complaint against the use of Elmiron on June 8, 2020. She began to use Elmiron for interstitial cystitis starting 2001 up to 2018. She claims that Elmiron caused her to develop serious visual damage, such as vision loss, eye color pigment, pigmentary maculopathy, and loss of night vision.
In 2019, Kimberly Pelczar was diagnosed with vision loss and permanent retinal injury, which she believes was the result of using Elmiron. Pelczar’s condition prompted her to file a case on March 26, 2020.
Pelczar started to use Elmiron in 2005. Ten years later, she began to develop visual problems. Pelczar alleged that Elmiron’s manufacturers tried to hide the risks of having eye problems caused by using the drug.
Janssen Pharmaceuticals and Johnson & Johnson have been silent concerning the issues that surround the use of Elmiron. However, lawyers are willing to help those who suffered eye problems due to the long term use of the drug. Those who took the drug before the added warnings regarding visual side effects and suffered visual impairments while taking Elmiron are qualified to file a lawsuit.
There is scientific proof that links the use of Elmiron to vision impairments. Scientists and other researchers have made efforts to warn the public regarding this matter. With that said, it is best to think twice about taking this medication and consult your doctor.
The Editorial Team at Healthcare Business Today is made up of skilled healthcare writers and experts, led by our managing editor, Daniel Casciato, who has over 25 years of experience in healthcare writing. Since 1998, we have produced compelling and informative content for numerous publications, establishing ourselves as a trusted resource for health and wellness information. We offer readers access to fresh health, medicine, science, and technology developments and the latest in patient news, emphasizing how these developments affect our lives.