What is Elmiron?
Elmiron is a medication prescribed to relieve the pain and discomfort of interstitial cystitis (IC). IC is also known as Painful Bladder Syndrome (PBS). It was originally approved by the FDA in 1996 and is supplied in 100 mg white opaque hard gelatin capsules. The generic name for Elmiron is polysulfate sodium.
IC is a chronic condition in which the patient may experience bladder pressure, bladder pain, pelvic pain, bladder frequency, urge incontinence, and painful sex. Women are much more likely to experience IC than men. The pain caused by IC can range from mild to severe.
Elmiron is the only drug approved by the FDA specifically for the treatment of interstitial cystitis.
FDA Adds New Warning to Elmiron Label
In June, the U.S. Food and Drug Administration (FDA) approved a new warning label for Elmiron after the medication had been linked to cases of eye damage and vision-related injuries. Despite receiving reports of pigmentary changes in the retina, also referred to as “pigmentary maculopathy” and several studies indicating a link between Elmiron use and eye damage, the label for Elmiron did not contain any warning about the potential for eye damage. Pigmentary maculopathy is progressive and permanent. It cannot be reversed.
The new warning label warns that use of Elmiron may cause “retinal pigmentary changes”. Because of the potential eye damage which may be caused by regular use of Elmiron, the FDA recommends doctors obtain a detailed ophthalmologic history in every patient prior to beginning a course of the drug.
What is retinal maculopathy and what are the symptoms?
In May of 2018 a team of opthalmologists at Emory University in Atlanta identified six patients who had been taking Elmiron with a newly discovered retinal disorder they named “retinal maculopathy”. Nearly all the patients in this study showed hyperpigmentation of the “subtle paracentral hyperpigmentation at the level of the reginal pigment epithelium (RPE)”. They describe retinal maculopathy as novel – and possibly avoidable.
The following retinal maculopathy symptoms may be related to the use of Elmiron:
- Difficulty reading
- Slow adjustment to low or dim lighting
- Blurred vision
- Night blindness
- Difficulty reading
- Dark spots in vision
- Loss of detailed vision
- Blurry vision
- Seeing dark spots
- Color blindness
- A change in eye color
What can you do?
If you are taking Elmiron and have experienced any changes in vision that may be related to the use of the drug should speak with a doctor about getting the appropriate eye exams. The FDA recommends all patients who have a pre-existing ophthamologic condition and all patients who have taken Elmiron for more than six (6) months receive a comprehensive retinal examination.
Patients who have been diagnosed with age-related macular degeneration, retinal deterioration, and pattern dystrophy – all diseases related to pigmentary maculopathy – who are taking Elmiron may actually be experiencing retinal maculopathy.
Trust our Massachusetts Elmiron attorneys to help
If you believe you have experienced vision loss or other eye damage after taking Elmiron, you may have a claim for money damages. Please call Attorney Marilyn McGoldrick at 1-888-341-1405 or tell us your story online for a free consultation with a recognized leader in personal injury and medical device litigation. You have nothing to risk. We offer a fair and accurate assessment of your case. All consultations are held in the strictest confidence.