March 2021: New Elmiron Medication Guide for Patients Points Out Retinal Pigmentary Eye Problems
(Posted by Tom Lamb at Drug Injury Watch)
By means of a March 12, 2021, Supplemental Approval letter for Elmiron (pentosan polysulfate sodium) capsules, the FDA announced that certain patient labeling information about Elmiron was being converted to a new Elmiron Medication Guide. In particular, as regards the pigmentary maculopathy Elmiron side effect, this 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....
This Elmiron Medication Guide mandated by the FDA Center for Drug Evaluation and Research (CDER) follows and reiterates the June 2020 Elmiron label change that added a new Warnings subsection, Retinal Pigmentary Changes, which starts with the following information:
Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON® (see ADVERSE REACTIONS). Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor....
As background, 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".
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In February 2021 we posted an article, "Past Elmiron Use Linked to Pigmentary Maculopathy and Vision Loss, Again, by Two Recent Medical Studies", in which we reported:
Two new medical journal articles provide further support for the fact that past Elmiron use is associated with pigmentary maculopathy and vision loss. Remarkably, according to one medical study, patients with high levels of Elmiron use have more than a 2-times increased risk for getting a diagnosis of pigmentary maculopathy or macular degeneration.
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 eye problems such as:
- Vision Loss / Blindness
- Maculopathy (retinal or pigmentation)
- Retinal Pigmentary Endothelium Injury (RPE)
- Pigmentation Maculitis
- Macular Degeneration (pigmentation or dry)
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.
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