Bladder Medication Elmiron May Cause Vision Loss
Elmiron®, or pentosan polysulfate sodium (PPS), is a prescription drug for treating interstitial cystitis (IC) or painful bladder syndrome. IC is a chronic bladder disease associated with severe bladder or pelvic pain, dyspareunia, and incontinence. This condition mainly affects women, with millions of women struggling with it in the United States.
IC can disrupt sleep and cause emotional stress. The FDA approved Elmiron in 1996 as the only oral medication for IC. Elmiron is a product of Jansen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson. In 2018, this medication surpassed $150 million in annual sales.
Recent years have seen several case reports and studies linking Elmiron to pigmentary maculopathy. This disorder may lead to blurry vision, dark spots, difficulty adapting to dim light, and vision loss.
Elmiron and Pigmentary Maculopathy
The macula is the central part of the eye’s retina. This sensitive part of the eye is essential for accurate vision. Maculopathy (or macular degeneration) is one of the many disorders that can affect the macula and is associated with the gradual loss of central vision.
Macular degeneration is often painless, and it can affect only one eye or both eyes. If the condition affects only one eye, the patient may not experience a significant loss of vision.
In 2018, the Atlanta-based Emory Eye Center found six patients with abnormal changes in their macula. The patients had no cases of retinal problems in their medical histories, and the only common feature was prolonged Elmiron use of about 15 years.
Kaiser Permanente doctors decided to do a follow-up study. They examined their database of more than 4 million patients and identified 140 patients who had taken an average of 5,000 pills over 15 years. Ninety-one of the 140 patients participated in the follow-up study.
The study revealed that 22 out of the 91 patients exhibited signs of drug toxicity. The toxicity rate increased with the amount of Elmiron taken. Those taking 500 to 1,000 grams of Elmiron had an 11% toxicity rate, while those taking at least 1,500 grams had a 42% toxicity rate.
According to a recent study, Elmiron dimming vision effects may continue to progress even after the patient stops taking the medication.
Emory School of Medicine researchers published a study in July 2020 in the medical journal JAMA Ophthalmology. The study revealed that some patients diagnosed with Elmiron-related maculopathy experience dimming vision that gets worse over time, even 10 years after the patients stopped taking the drug. The study involved 11 female patients aged 53 to 63 years who had been diagnosed with Elmiron-induced maculopathy.
The researchers wanted to find out what happens six months to 10 years after Elmiron medication cessation. The patients exhibited no significant improvements in their vision after halting Elmiron usage. Additionally, the conditions of 82% of the patients seemed to get worse.
From the findings of this study, the researchers concluded that Elmiron dimming vision effects continue to evolve after medication cessation for at least 10 years. The study adds weight to a 2019 case study published in Ophthalmic Surgery, Lasers and Imaging Retina about a 69-year-old woman whose vision had continued to deteriorate six years after she stopped taking Elmiron.
Mitigating Elmiron Dimming Vision Effects
Researchers behind the recent studies recommend that patients on Elmiron medication should have their vision examined at least once every year throughout their treatment. If detected early, the damage can possibly be mitigated by the patient halting the use of the medication.
At an advanced stage, the drug toxicity can mimic late-stage atrophic age-related macular degeneration that may lead to permanent blindness. Regular examination is especially important for patients who already experience vision problems.
Patients with a history of specific eye disease are more susceptible to Elmiron dimming vision effects. Such patients need to undergo comprehensive evaluation before commencing Elmiron medication.
Elmiron Dimming Vision Lawsuits
While concerns about Elmiron’s detrimental effects on eye health have been around for years, Jansen Pharmaceuticals did not include Elmiron vision warnings in the drug label until June 2020 in the United States. However, the drug’s warning label was updated in April 2020 in Canada to include information about the implications of prolonged exposure to Elmiron.
The drug manufacturer updated the label after a series of case reports and independent studies highlighted cases involving dimming vision and other visual health complications among Elmiron’s long-term users.
Due to their failure to warn consumers for years against Elmiron’s effects on vision, the drug manufacturer now faces an increasing number of lawsuits filed by patients left with irreversible and potentially worsening eye-health complications.