Many recent studies have found a clear link between use of the drug Elmiron and a unique type of macular degeneration. As a result, hundreds of people have filed Elmiron lawsuits against Johnson & Johnson and their pharmaceutical subsidiary, Janssen, alleging that the company’s bladder drug Elmiron caused them to suffer from vision loss.
November 2018 Ophthalmology study
A November 2018 study published in Ophthalmology found an association between Elmiron exposure and pigmentary maculopathy. The researchers examined the medical records of six Elmiron patients who suffered from pigmentary maculopathy. The patients’ ages ranged between 37 and 62 years. They used Elmiron for an average of 15.5 years.
The median cumulative exposure was over 2,200 grams. The patients underwent multiple genetic tests that were negative. This suggested that genetics did not cause pigmentary maculopathy. The researchers concluded that chronic Elmiron exposure was associated with a “novel” form of maculopathy.
January 2021 Urology review
In a January 2021 Urology-published review, researchers examined current literature on Elmiron’s association with macular disease. They identified 14 papers on this topic. Most of them looked at how macular disease developed in Elmiron-exposed patients. The researchers found that Elmiron patients were more likely to be diagnosed with maculopathy after years of taking it. They concluded that the currently available data suggested that taking Elmiron for several years increased the maculopathy risk. The researchers recommended that patients taking the drug undergo regular ophthalmic examinations.
February 2021 Clinical Ophthalmology study
Clinical Ophthalmology published a study in February 2021 that looked at Elmiron-related maculopathy’s prevalence. The researchers examined the medical records of 131 Elmiron patients, 40 of which underwent multimodal imaging. The imaging of five patients showed features that suggested Elmiron-related maculopathy. An additional five of the 91 Elmiron patients who did not undergo imaging showed macular pigmentary changes.
These ten patients took Elmiron for an average of four years. The average dose was 380 grams. By contrast, the average dose for Elmiron patients who showed no maculopathy signs was 188 grams. The researchers concluded that multimodal imaging could identify Elmiron-related maculopathy.
May 2021 Survey of Ophthalmology review
In a May 2021 review published in the Survey of Ophthalmology, researchers examined several studies that looked at the association between long-term Elmiron use and retinal maculopathy. They found that the current literature found a “strong dose-dependent association between” Elmiron exposure and retinal maculopathy.
The researchers also found that patients’ retinal condition worsened after cessation. They identified several symptoms, including reading difficulties with preserved visual acuity and delayed dark adaption. The researchers concluded that ophthalmologists should use multimodal retinal imaging to screen Elmiron patients. They also advised healthcare providers to prescribe minimal doses and durations.
September 2021 Journal of Urology review
In a September 2021 Journal of Urology-published study, researchers found an association between high Elmiron doses and vision complications. Their data comprised 64 Elmiron patients, 37 of which discontinued taking it. The researchers found that patients that received maculopathy diagnoses were more likely to stop taking the drug than those who did not. They also found that Elmiron doses greater than 500 grams were associated with ocular complications. The researchers concluded that healthcare providers should consider whether the drug’s benefits outweigh its risks. They recommended that physicians counsel patients on Elmiron’s risks and consider making ophthalmologic referrals to patients taking high doses.
October 2020 Elmiron lawsuit
An Ohio woman filed suit against in New Jersey federal court on October 5, 2020. She alleged that her Elmiron use caused her retinal pigmentary changes. The woman took the bladder drug between July 2009 and May 2020. Her lawsuit claimed that she may develop permanent vision damage. The woman alleged negligence, strict products liability, express warranty breach, fraudulent misrepresentation, and fraudulent concealment against Elmiron’s manufacturers and distributors. This is one of several Elmiron lawsuits filed in New Jersey.
August 2021 Elmiron lawsuit
On August 16, 2021, an Oklahoma woman filed a lawsuit in New Jersey federal court. She alleged that she suffered macular degeneration from taking Elmiron. The woman took the drug for 16 years. She was diagnosed with multiple injuries, including age-related macular degeneration, on September 18, 2019. The woman alleged negligence, strict products liability, express warranty breach, and fraudulent misrepresentation against Johnson & Johnson and Janssen Pharmaceuticals.
U.K. Requires Warning on Elmiron
On September 19, 2019, the British government released a Drug Safety Update on Elmiron. It warned that the bladder drug was associated with pigmentary maculopathy. It advised Elmiron patients to undergo routine ophthalmic examinations. The update also advised healthcare professionals to stop prescribing Elmiron to patients suffering from pigmentary maculopathy.
Canadian Warning on Elmiron
The Canadian government announced in October 2019 that it included the pigmentary maculopathy risk in Elmiron’s Canadian product monograph. The monograph stated that reported chronic Elmiron use was associated with pigmentary maculopathy. It advised that patients who frequently take the drug should undergo routine ophthalmic examinations to timely detect the condition. The monograph also advised that health care providers should discontinue Elmiron in patients suffering from pigmentary maculopathy.
FDA Requires Elmiron Label Change
The FDA announced on June 16, 2020, that it updated the Elmiron label to include pigmentary maculopathy to the label’s “Warnings and Precautions” and “Adverse Reactions” sections. The “Warnings and Precautions” section listed several symptoms, including reading difficulties, slow adaptation to low light environments, and blurry vision. It also advised patients to undergo regular eye exams, even after cessation.