The prescription drug Elmiron has been linked to vision loss, including macular degeneration and maculopathy. It is suspected that the manufacturers of this commonly prescribed interstitial cystitis drug knew or should have known of its toxic side effects but did not issue a warning of its risks.
Failure to Warn the Public
The FDA approved Elmiron in 1996 for use in treating interstitial cystitis, which is a painful bladder syndrome that causes severe and chronic pain in the bladder and groin. More than one million people in the United States suffer from this condition and are at risk of vision loss from Elmiron.
Product liability and personal injury lawyers purport that Elmiron-related eye problems could have been prevented if the manufacturers had given earlier warnings about the drug causing macular degeneration and maculopathy. Manufacturers did not include warnings and information about the potential risk of using this drug on its label until June 16, 2020. Information about the drug’s risk of causing retinal pigmentary changes was added at that time.
Side effects that Elmiron users may experience from the maculopathy it causes include:
- Vision loss
- Loss of night vision
- Reading difficulty
- Loss of vision detail
- Inability to drive
Elmiron-related vision problems will continue to worsen the longer the drug is used. However, vision problems will continue to degrade after the medication is stopped. Users are likely to experience difficulties with adjusting to dark light, centralized dark spots, and centralized darkness.
Studies Highlight Possible Link
The first concerns over the link between Elmiron and vision problems were discovered in May 2018 by researchers at the Emory Eye Center in Georgia. The researchers published their findings in the medical journal Ophthalmology. The research suggests that long-time use of the drug could cause atypical maculopathy and eye deterioration in the retina areas where highly detailed vision is controlled.
Several studies have been published, highlighting the risk between pigmentary maculopathy and Elmiron. Because of its prevalence, this retinal disease is now often described as Elmiron maculopathy.
Warning updates were given in Canada in 2019. However, consumers and doctors in the United States were not notified until 2020. Because drug makers withheld information about the drug’s risks, optometrists often misdiagnose Elmiron vision problems as other eye conditions, including pattern dystrophy or other retinal diseases.