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For decades, Janssen Pharmaceuticals has been the only company allowed to manufacture and sell pentotan polysulfate sodium (PPS) or Elmiron®, which is also the only oral medication approved to treat the symptoms of interstitial cystitis. After multiple clinical studies in peer-reviewed publications have showed a link between Elmiron® and serious eye injuries, however, Janssen Pharmaceuticals has now officially added a new warning label to this medication.
In recent years, the evidence has been mounting against the use of Elmiron®. This began when a 2018 study first showed a link between Elmiron and retinal eye injuries, which could lead to blurred vision and eye strain. Later, researchers at the Emory Eye Center discovered a brand new kind of degenerative eye disorder: pigmentary maculopathy, which only appeared in users of Elmiron®. More recent studies have supported this finding, making it virtually impossible for Janssen Pharmaceuticals to continue ignoring the problem.
The new warning label recommends that doctors ask patients about any family and personal medical histories of eye problems before prescribing Elmiron®. Because interstitial cystitis is a chronic bladder problem that affects over 1 million Americans, however, it may be difficult to correct the damage done to existing long-term users at this point.
Consequences of taking Elmiron® for more than 6 months can include:
- Loss of color perception, clarity, and crispness
- Blurred or dimmed vision
- Difficulty adjusting to dark environments
- Eye strain
- Vision loss and permanent blindness
While it is unclear if Janssen knew that Elmiron® causes eye damage before the current wave of research, some experts have claimed that the company has actually known for nearly 20 years, as early clinical trials suggested that there could be vision-related adverse events. Even if their knowledge did not include a full awareness of pigmentary maculopathy, Janssen Pharmaceuticals and parent company Johnson & Johnson may still be liable for dangerous drug injuries.
At Tate Law Group, LLC, our product liability lawyers have helped countless clients in Savannah and beyond with pharmaceutical litigation. Bringing a claim against a company like Janssen may be overwhelming, but with the assistance of our skilled and experienced team, you can focus on your healing process while we seek fair recovery on your behalf.
Contact us at (912) 234-3030 to schedule a free consultation.