According to studies, a unique type of pigmentary maculopathy and other vision problems have been linked to the use of Elmiron- a product used to relieve the pain caused by interstitial cystitis.
As this information raises many concerns from interstitial cystitis patients, the Food and Drug Administration (FDA) warns the public of its use. Furthermore, the FDA assures the public that an investigation with close supervision will be conducted regarding the matter.
Understanding Interstitial Cystitis
Interstitial cystitis is a bladder disorder that causes pain and discomfort to anyone who has it. The pain and discomfort of having this condition can range from mild to severe. Up to this date, experts do not know the cause of interstitial cystitis and how it can be cured. Moreover, since there is no cure, patients resort to medication that can help relieve bladder discomfort.
This disorder, which is also known as painful bladder syndrome, is usually experienced by women. However, men and kids can also suffer from this condition. Most of the time, interstitial cystitis is hard to diagnose. This is because it carries similar symptoms present in other disorders, such as bladder cancer, chronic pelvic pain syndrome, urinary tract infection, chronic prostatitis, and endometriosis.
Background of Elmiron
Concerning the information above, Elmiron is the only known product that specifically relieves the pain and discomfort of having interstitial cystitis. The drug has no generic equivalent and is produced by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. Elmiron has been in the market since 1996. Many patients have already been using Elmiron for an extended period of time.
Most of Elmiron’s common side effects are bruising, abdominal pain, hair loss, abnormal liver function tests, diarrhea, blood in the stool, headache, nausea, dizziness, and rash upset stomach. All of the side effects enlisted are included in Elmiron’s leaflets and official website. However, this year was the only year Janssen Pharmaceuticals decided to include vision-related side effects in its US market due to the researchers and the consumers’ outcry.
Some victims decided to file lawsuits against the manufacturer of Elmiron because of the published studies that support the link of the use of Elmiron to vision problems. These interstitial cystitis patients demand justice and are hoping for a reasonable Elmiron vision loss compensation.
An example of this would be Kimberly Pelczar, who was diagnosed with vision loss and permanent retinal injury. Pelczar claims that after ten years of using Elmiron to relieve her interstitial cystitis, she began to have vision problems, resulting in her current diagnosis. As such, Elmiron lawsuits are expected to rise as more and more patients find out they developed vision problems due to using Elmiron.
What is pigmentary maculopathy?
In general, maculopathy is a disease that affects the macula and can eventually lead to permanent vision loss. On the other hand, pigmentary maculopathy is the same as regular maculopathy but shows pigmented deposits on the macula. Such pigmented deposits are like specks that are visible in the macula. Furthermore, researchers found out that pigmentary maculopathy is rare only to Elmiron users.
Suppose patients notice the development of pigmentary maculopathy due to using Elmiron at an early stage. In that case, it can be stopped by refraining the use of Elmiron and taking proper medication. However, if caught in a later stage, it might be too late and can result in vision loss. Therefore, if you are an Elmiron user, it is wise to get regular eye checkups.
Studies Supporting the Connection of Elmiron to Vision Problems
Studies linking Elmiron to several vision problems have appeared since 2018. Since then, consumers were made aware of the additional risks of taking Elmiron. Below is a timeline of the studies that helped consumers know the hidden truth:
Dr. William A. Pearce and his colleagues at the Emory Eye Center conducted a study among six adults, who are Elmiron users. It was found out that the use of Elmiron led to the “injury in the retina and the underlying retinal pigment epithelium,” as emphasized by Dr. Pearce. Besides that, the case study was published in the Journal of Urology and was the start of a series of studies linking Elmiron to possible vision loss.
Experts at the Emory Eye Center conducted an expanded case study with 10 Elmiron users and was published in the Journal of Urology. They concluded that patients who have interstitial cystitis and have no history of taking Elmiron did not develop any pigmentary maculopathy. As such, the doctors behind the research recommended that Elmiron users undergo eye examinations to ensure safety.
Drs. Rachel M. Huckfeldt and Demetrios G. Vavvas conducted a study with one interstitial cystitis patient whose pigmentary maculopathy continued to worsen even after stopping Elmiron’s use. So far, this is the only patient recorded to have experienced such a situation. Furthermore, the case report was published in Ophthalmic Surgery, Lasers, and Imaging Retina.
Drs. Amar P. Patel, Ronald Melles, and Robin A. Vora conducted research involving 117 interstitial cystitis patients who took Elmiron. The researchers noticed that 27 out of 117 patients had absolute signs of maculopathy. Moreover, they noted that those who took more than 1,500 grams had a higher risk of toxicity.
Having interstitial cystitis is challenging as it is. And developing vision problems like pigmentary maculopathy will make a patient’s life even harder. Hence, it is crucial to take caution in taking Elmiron. However, if there is a need to use the product, it is best to consult your doctor.