The Centers for Disease Control and Prevention estimates that up to 12% of women have a bladder condition called interstitial cystitis. IC causes chronic bladder and pelvic pain along with urinary frequency. The only prescription drug to treat IC, Elmiron, received Food and Drug Administration approval in 1996.
However, new studies show that long-term use of this Johnson & Johnson drug may lead to eye disease and vision loss. In addition, a 2020 lawsuit filed in the Eastern District of Pennsylvania alleges that the drug manufacturer’s subsidiary, Janssen Pharmaceuticals, failed to warn patients about the risks associated with Elmiron.
Symptoms of vision complications
Janssen reports that fewer than 1% of individuals who take Elmiron may develop vision complications such as retinal hemorrhage, amblyopia, optic neuritis and conjunctivitis. However, the company does not mention the risk for pigmentary maculopathy, a disease that affects the eye’s light-sensitive retina. Maculopathy is a painless but serious condition that results in progressive vision loss. Typically, the person first notices a dark spot in his or her vision that grows larger over time. Other symptoms include distortion of images, difficulty adjusting the eyes in bright light, inability to detect color and contrast, blurry vision, and hallucinations such as flashing lights.
Manufacturer liability
The Elmiron lawsuit claims that Janssen Pharmaceuticals negligently withheld evidence from patients about the link between the drug and severe visual side effects, including the development of pigmentary maculopathy. Though Canada required the manufacturer to create a label disclosing this link in 2019, the United States version of the Elmiron label reportedly reads “Warnings: None.”
While maculopathy often occurs as part of the aging process, young and middle-aged adults have presented with this condition after taking Elmiron for an average of 15 years. If you or a loved one experiences symptoms of vision loss and has an Elmiron prescription to treat IC, talk to your health care provider. You may be eligible for financial damages associated with this prescription drug defect.