Elmiron’s warning label was recently amended to include retinal pigmentary changes. The drug maker Janssen Pharmaceuticals caved to pressure due to increasing evidence that the prescription medication used to treat the bladder condition interstitial cystitis can cause vision problems including blindness in some patients.
Shouse Law Group is bringing Elmiron lawsuits on behalf of patients who have developed pigmentary maculopathy from taking the medication. We are suing Janssen for large settlements cover our clients’ medical costs, lost wages, lost earning capacity, and pain and suffering.
In this article, our Elmiron attorneys discuss:
- 1. What is on Elmiron’s warning label?
- 2. Did the warning label always include retinal problems?
- 3. Why did the warning label change?
- 4. Does Elmiron’s label list other precautions?
1. What is on Elmiron’s warning label?
Retinal Pigmentary Changes
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.
Visual symptoms in the reported cases included difficulty reading, slow adjustment to low or reduced light environments, and blurred vision. The visual consequences of these pigmentary changes are not fully characterized. Caution should be used in patients with retinal pigment changes from other causes in which examination findings may confound the appropriate diagnosis, follow-up, and treatment. Detailed ophthalmologic history should be obtained in all patients prior to starting treatment with ELMIRON®. If there is a family history of hereditary pattern dystrophy, genetic testing should be considered. For patients with pre-existing ophthalmologic conditions, a comprehensive baseline retinal examination (including color fundoscopic photography, ocular coherence tomography (OCT), and auto-fluorescence imaging) is recommended prior to starting therapy. A baseline retinal examination (including OCT and auto-fluorescence imaging) is suggested for all patients within six months of initiating treatment and periodically while continuing treatment. If pigmentary changes in the retina develop, then risks and benefits of continuing treatment should be re-evaluated, since these changes may be irreversible. Follow-up retinal examinations should be continued given that retinal and vision changes may progress even after cessation of treatment.1
2. Did the warning label always include retinal problems?
No. It was only on June 16, 2020 that Janssen Pharmaceuticals finally updated Elmiron’s warning label to include retinal problems.2 The Food and Drug Administration (FDA) first approved Elmiron in 1996, so the drug has been on the market for 24 years without any warning about the severe eye maladies it can cause.3
3. Why did the warning label change?
Janssen Pharmaceuticals was facing mounting pressure due to litigation by patients claiming Elmiron caused their vision problems. These plaintiffs’ claims are backed by science:
In 2018, the American Academy of Ophthalmology (AAO) put out a piece regarding six Emory Eye Center patients who developed pigmentary maculopathy from taking Elmiron.4 And in 2019, the AAO published a follow-up about more Emory Eye Center patients who developed the same condition from Elmiron.5
4. Does Elmiron’s label list other precautions?
Yes. Elmiron’s packaging discloses the following precautions and side effects:
- Elmiron is a weak blood thinner. 6.3% of patients reported a rectal hemorrhage. Other reported adverse reactions include ecchymosis, epistaxis, and gum hemorrhage. Patients should be evaluated before taking Elmiron if they have aneurysms, thrombocytopenia, hemophilia, gastrointestinal ulcerations, polyps, or diverticula.
- Elmiron has been associated with alopecia. In clinical trials, 97% of the cases were alopecia areata, limited to a single area on the scalp.
- Patients with hepatic impairment might experience mildly elevated transaminase, alkaline phosphatase, γ-glutamyl transpeptidase, and lactic dehydrogenase.
- It is not known whether nursing mothers who take Elmiron excrete the medicine into their breast milk.
- It is also not known whether Elmiron is safe and effective in patients under age 16.6
- ELMIRON®-100 MG (Pentosan Polysulfate Sodium) Capsules prescribing information, FDA.
- Teresa Shaw, Painful Bladder Medicine Elmiron Associated with Vision Damage, MedNews 365 (November 4, 2020)
- Joseph T Nezgoda, MD MBA, Nieraj Jain, MD, Pigmentary Maculopathy From Chronic Exposure, AAO (December 7, 2018).
- More Evidence Linking Common Bladder Medication to a Vision-threatening Eye Condition, AAO (October 12, 2019).
- See note 1.