The new Elmiron Medication Guide mandated by the FDA Center for Drug Evaluation and Research (CDER) in March 2021 follows and reiterates the June 2020 Elmiron label change that added warning about the pigmentary maculopathy Elmiron side effect.
We point out that before the June 2020 Elmiron label change adding this new warning about the pigmentary maculopathy Elmiron side effect, the Elmiron drug label had stated “Warnings: None”.
As regards the pigmentary maculopathy Elmiron side effect, the new Elmiron Medication Guide includes the following:
Changes in the retina of the eye (pigmentary maculopathy). Taking ELMIRON may be associated with pigment changes in the retina of the eye that may continue even after stopping treatment with ELMIRON. Tell your healthcare provider including your eye doctor right away if you have any vision changes including any of these symptoms:
- difficulty reading
- your vision takes longer to adjust to low or reduced light
- blurred vision
Throughout your treatment, regular eye examinations that include retinal examinations are suggested for early detection of retinal/macular changes….
As we have stated previously, the June 2020 Elmiron label change that finally added warnings concerning vision problems such as retinal pigmentary changes and pigmentary maculopathy was overdue from our perspective. Accordingly, there have been Elmiron lawsuits filed by patients who have suffered vision loss against the pharmaceutical companies responsible for Elmiron.
We are currently investigating possible Elmiron lawsuits for patients with past Elmiron use diagnosed with retinal pigmentary eye problems such as the pigmentary maculopathy Elmiron side effect.
If we can be of assistance to you or someone you know with Elmiron-related eye damage, you can send an email to Tom Lamb or you can call us on our toll-free number: 800-426-9535. Or, if you prefer, simply submit an online Elmiron Case Evaluation Form — it is free, confidential, and there is no obligation.[View article at original source]