Canadian Government Warns Of Risk Of Retinal Damage From Elmiron
The Canadian government has issued a safety alert about the risk of a form of retinal damage known as pigmentary maculopathy which is associated with Elmiron.
The alert states that pigmentary maculopathy cases have been reported regarding Elmiron and long-term use, and that the interstitial cystitis drug is now contraindicated in patients with a macular pathology history.
The alert advises healthcare professionals to assess the benefits and risks of Elmiron with patients, obtain all patients’ detailed ophthalmologic history before starting them on Elmiron, perform regular and baseline retinal exams to detect macular pathology early and advise patients to report vision changes such as wavy or blurry vision in or near the center of one’s vision field, slow adjustment to reduced or low light or problems reading.
The alert states that most retinal changes occur in patients who have taken Elmiron for three years or longer, but that some cases have been seen in a shorter time period. The alert states that the retinal changes can lead to permanent vision loss.
Study Discovers Dose/Response Association Between Eye Damage And Elmiron
A recent study found that “those in the highest PPS exposure category were more likely to have difficulties reading small print and to report a prior diagnosis of macular disease,” suggesting that the risk for eye damage increases as one is exposed to more and more Elmiron.
The study had 912 respondents with interstitial cystitis complete a 27-item online survey.
Lawsuit Alleges Elmiron Use Caused Illinois Man To Suffer From Vision Damage
A lawsuit filed on December 1 in federal court in Illinois alleges that the use of Elmiron from 1997 through 2003 caused an Illinois man to develop difficulty reading, difficulty adapting to dim lighting, and cloudy, distorted and blurred vision.
The lawsuit claims that the defendants, including Janssen Pharmaceuticals, Johnson & Johnson and Ortho-McNeil Pharmaceuticals, knew or should have known that Elmiron posed a risk of vision damage yet failed to warn the public about the risk.
The lawsuit notes that the new, unique eye disease which Elmiron allegedly causes was noted in findings published in 2018 by the Emory Eye Center. Researchers there found six patients with a new, novel form of eye damage, poured through their patient histories and discovered that all six patients had taken Elmiron.
The lawsuit seeks to recover damages based on multiple counts, including:
- Strict liability: design defect and failure to warn
- Breach of express warranty
- Breach of implied warranty
- Negligence per se
- Negligent misrepresentation