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Is Janssen Pharmaceuticals Adding A Warning To Elmiron?
Elmiron is the only FDA-approved medication to treat interstitial cystitis, commonly known as painful bladder syndrome. However, as the team at Colson Hicks Eidson has previously reported, this medication is known to cause irreversible eye damage in patients. Those who have taken this medication were never warned that they could sustain eye damage. Now, a new label has been issued. Janssen Pharmaceuticals has updated its label for Elmiron to address this risk.
What Is Changing With The Elmiron Label?
The issues with the prescription medication Elmiron were first discussed by Dr. Neiraj Jain when he and his colleagues wrote a letter to the editor of the Journal of Urology discussing a new condition they were seeing amongst patients taking Elmiron.
Dr. William A. Pearce and colleagues at the Emory Eye Center stated that those who took pentosan polysulfate sodium (Elmiron) saw an increased risk of serious eye damage. Further studies have indicated that a buildup of pentosan polysulfate sodium occurs in patients’ eyes to cause pigmentary maculopathy. Amongst the most common symptoms associated with pigmentary maculopathy include the following:
- Difficulty reading
- High pain
- Difficulty adapting to dim lighting
- Distorted vision
- Vision disturbances
- Trouble seeing things up close
Reports indicate that those who have taken this medication for seven years or more face an increased risk of developing pigmentary maculopathy.
Janssen Pharmaceuticals, the only manufacturer of this medication, has finally addressed this issue. Under pressure from consumers and researchers, the pharmaceutical company has changed the label of this medication to indicate that it could cause irreversible eye damage. The new warning alerts both doctors and patients and asks them to watch out for changes in the retina of the eye. Among the wording of the warning, including notes that changes in the retina “have been identified with long-term use of Elmiron,” while also acknowledging that there have been issues with short-term usage as well.
It has taken some time for Janssen Pharmaceuticals to issue this warning. Despite the numerous studies that have been released over the last few years about the dangers of Elmiron, Janssen made no moves to provide warnings to patients and doctors. The Interstitial Cystitis Network (ICN) submitted a petition to the FDA and asked that the agency require the pharmaceutical company to update its product label.
Our Team Is Ready To Help You Today
If you or somebody you love has taken the prescription medication Elmiron and have subsequently been diagnosed with vision loss or irreversible damage, contact the Elmiron attorneys at Colson Hicks Eidson today. We have extensive resources and legal experience ready to bring to your case. Our goal is to conduct a complete investigation into your case so we can secure any compensation you may be entitled to. This could include coverage of any medication or medical care required due to the vision loss, lost income or loss of earning potential, loss of personal enjoyment damages, possible punitive damages against Janssen Pharmaceuticals.