Janssen Pharmaceuticals, a subsidiary of personal care and pharmaceutical
giant Johnson & Johnson, recently announced the addition of a
new warning label to the bladder drug Elmiron®, which has been shown to cause a serious
degenerative eye disorder called pigmentary maculopathy. This condition
leads to vision loss and eye damage, and according to a Kaiser Permanente
study performed last year, up to 25% of all Elmiron® users may develop
retinal damage as a direct result of taking the drug.
Janssen added the warning label on June 2, 2020, with the
U.S. Food & Drug Administration (FDA) publishing the approved drug label on June 16. The label advises
doctors to ask patients about their ophthalmological history and family
eye health history before prescribing Elmiron®, as these may be risk
factors for the development of pigmentary maculopathy. It also notes that
most of the current cases are linked to long-term Elmiron use, but that
cases have been reported with less than 3 years of use as well.
Pigmentary maculopathy is considered to be a “novel” eye disorder,
and so far, it has only been associated with taking Elmiron® (comprised
of pentotan polysulfate sodium or PPS). The first clinical study showing
a link between this drug and pigmentary maculopathy was published in 2018,
and there have been many similar studies since that time.
The new warning label lists the following symptoms and adverse reactions:
As the only available oral medication for treating interstitial cystitis,
Elmiron® is taken by over 1 million Americans nationwide each year.
That means millions of patients could be at risk for vision loss, eye
strain, and other lasting consequences after taking this defective drug.
If you believe that Elmiron® may have contributed to your eye injuries,
you’re not alone in this fight. Our Indianapolis attorneys at Wagner
Reese are committed to representing your needs and helping you seek fair
compensation through the civil justice system. By holding pharmaceutical
companies like Janssen accountable for failing to warn patients, it is
our hope that we can help restore our client’s lives to some degree
and protect future patients who rely on medication every day.
Contact Wagner Reese at (888) 204-8440 to get started with a free consultation.