Over the past few years, Elmiron (pentosan polysulfate sodium, “PPS”), a therapy designed to treat patients with interstitial cystitis (IC), has been associated with potential vision damage. Despite a variety of research suggesting this, drug manufacturer Janssen Pharmaceuticals (“Janssen”) made few changes until June 2020, when the drug’s label finally warned of potential damage. Currently, multiple lawsuits are taking place to hold Janssen liable. According to New York Injury Law News, new research and evidence again link Elmiron to vision damage, an additional blow for Janssen. Read the newly published evidence in the Canadian Journal of Ophthalmology.
According to RXList, Elmiron is:
a weak blood thinner and also works as a bladder protectant used to treat bladder pain and discomfort caused by cystitis (bladder inflammation or irritation).
Currently, Elmiron is the sole FDA-approved treatment for IC. Previously, Elmiron received Orphan Drug status. The orally administered treatment must be taken continually to provide relief from IC-related symptoms, meaning patients are often taking the drug for years at a time. Associated side effects include nausea and diarrhea, hair loss, and abdominal pain.
Prior studies have already linked Elmiron with vision damage. For example, research performed by Kaiser Permanente in 2019 highlighted how 22% of patients taking Elmiron for at least 5 years showed signs of PPS-associated maculopathy, a rare vision-threatening macular disease. According to the American Association of Ophthalmology (AAO) EyeWiki, PPS-associated maculopathy:
often causes symptoms of prolonged dark adaptation and nyctalopia and may cause blurred vision. While visual acuity may initially remain intact, cystoid macular edema, macular neovascularization, and retinal pigment epithelium (RPE) atrophy may occur resulting in severe vision loss.
In this most recent study, researchers sourced data from patients with IC treated at the University of California – Los Angeles (UCLA). During their treatment, patients received Elmiron. Next, patients received retinal imaging screening to evaluate macular damage. Ultimately, researchers determined that:
- Approximately 20% of patients showed signs of PPS-associated maculopathy. Unlike other macular damage or degeneration, PPS-associated maculopathy presents wholly unique macular damage.
- Signs of PPS-associated maculopathy include small dark spots on the retina and macula, as well as yellowish subretinal deposits. Additionally, patients also experience vision damage and vision loss.
- Altogether, patients who took lower Elmiron doses, or received Elmiron for shorter time periods, showed no symptoms of PPS-associated maculopathy.
- Patients with IC who are taking Elmiron, particularly for longer periods, should receive annual retinal imaging to identify any emerging problems.
Interstitial Cystitis (IC)
Interstitial cystitis (IC) is a chronic bladder issue resulting in recurrent pelvic pain and pressure. Altogether, IC sits under the umbrella category of painful bladder syndrome (PBS). Normally, the bladder fills and then, via pelvic nerves, tells the brain that it is time to urinate. But in patients with IC, these nerves get confused, causing pain and frequent urination (despite less urine volume).
While doctors are not sure of the exact cause of IC, many believe that genetic and environmental factors play a role. Additionally, some doctors are looking into potential allergic or autoimmune causes. Risk factors include being female, having fair skin or red hair, having a chronic pain disorder, or being older than 30. Symptoms may flare when presented with certain triggers, such as stress, menstruation, or sexual activity. These symptoms include:
- Pain during sexual intercourse
- Frequent urination
- Urinary urgency
- Abdominal, urethral, or vaginal pain
- Pain when the bladder fills
- Chronic pelvic pain