Elmiron is a mild blood-thinner drug that has been around since 1996 and is prescribed to treat bladder pain or inflammation, a condition called interstitial cystitis.
Since it is the only oral medication approved to treat IC, it has been used by hundreds of thousands of patients, earning an average of $150 million per year for manufacturer Janssen Pharmaceutica.
However, recent studies have linked Elmiron to a severe eye disease called retinal maculopathy. This raises questions about the overall safety of the drug, as well as whether Janssen may have hidden the risks for decades.
Doctors at Atlanta’s Emory Eye Center first noticed retinal maculopathy in patients taking Elmiron in 2017. Much like age-related macular degeneration, the condition can change the pigment in retina cells, causing eye dysfunction and vision loss.
It was so similar to macular degeneration, in fact, that they worried that many patients taking Elmiron may have already been misdiagnosed with macular degeneration.
After hearing of the Emory study, other eye doctors around the country began piecing together the puzzle, finding similar results with their patients taking Elmiron.
In a larger study, Kaiser Oakland discovered that 24% of Elmiron users had retinal maculopathy and pigmentary damage, just like that found in the original Emory patients.
A Harvard case study then reiterated the dangers as it detailed a patient with progressive retina damage who had continued to experience worsening of her vision even 6 years after stopping Elmiron use.
Finally, IC Network conducted a study of 1,604 members taking Elmiron, finding a whopping 53.87% had developed a retinal disease.
Although the FDA has been notified of these findings, they have yet to order a recall of Elmiron or add any warnings to the drug. The FDA Adverse Event Reporting System database currently lists almost 100 cases of eye-related side effects among patients taking Elmiron.
This isn’t the first time, however, that these risks have surfaced. In preparing to present their findings, doctors at Emory Eye Center researched the initial clinical trials of Elmiron that were conducted in the 1990s, well before the drug was approved.
They found that in a study of nearly 2,499 people taking Elmiron before it was introduced to the market, a number of patients suffered both vision loss and eye related side effects. Specifically, some developed optic neuritis and retinal hemorrhage.
Although Janssen was informed of these results and had the information for more than 20 years, they never added any warnings to Elmiron’s label, or conducted any further research to find out the severity of eye disorders from the drug.
Now, lawyers say Janssen could be forced to pay compensation to thousands of patients who may have suffered retinal maculopathy from the drug, thinking it was macular degeneration.
If you or a loved one suffered vision loss or were diagnosed with an eye disease after taking Elmiron, it’s important to speak with a lawyer about your rights. Contact us today for more information.
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