Elmiron: Pentosan Polysulfate Sodium (PPS) Medication for Treatment of
According to its website, “ELMIRON® is a prescription medicine used to treat bladder pain or discomfort associated
with interstitial cystitis.” You may also notice that the first
serious side effect listed in the “Important Safety Information”
section on the website is “Changes in the retina of the eye (pigmentary
maculopathy)” written in bold print.
In the last few years, the manufacturers of Elmiron have had well over
1,500 lawsuits filed against them in state and federal courts. Many of
these lawsuits were filed by individuals who claim to suffer with maculopathy
as a result of using Elmiron.
Maculopathy is a disease involving damage to the macula, the central part
of the retina. Damage to the macula can cause:
- Patches of blurriness in your vision
- Complete blindness
- Dark spots in center of vision
- Color distortions
- Straight lines to appear wavy
- Difficulty focusing on small details
Doctors now recommend getting a yearly screening if you continue using
the medication. If you learn that there is any damage to your eye, you
should talk with your doctor right away about whether you should stop
taking Elmiron. You can mitigate the damage to your macula if you discontinue
the medication early enough.
Regrettably, the potential danger of Elmiron causing pigmentary maculopathy
or other eye conditions was publicly uncovered long after the release
of the drug, and after thousands and thousands of people started using
Elmiron. In an
October 2019 study presented at the Annual Meeting of the American Academy of Ophthalmology,
3 researchers showed that “about one-quarter of patients with significant
exposure to Elmiron showed definite signs of eye damage, and that this
medication toxicity could masquerade as other known retinal conditions,
such as age-related macular degeneration or pattern dystrophy.”
Janssen Pharmaceuticals, the maker of Elmiron, now places that warning
quoted above concerning pigmentary maculopathy front and center on the
Elmiron website to warn people who are taking or considering taking the
drug. But plaintiffs across the country are alleging that for years the
makers of Elmiron failed to adequately warn of the potential dangers of
the medication. Thousands of plaintiffs are now suing Janssen Pharmaceuticals
due to their failure to warn about the potential dangers of Elmiron, and
much of the litigation has been consolidated into multi-district litigation
(MDL) in the U.S. District Court, District of New Jersey.
In MDLs, typically hundreds or even thousands of individual lawsuits with
similar allegations are transferred to one federal district court so that
one judge handles the pretrial discovery and litigation process. MDLs
are fairly common in product liability drug cases, where thousands of
individuals all may be alleging to be suffering from similar ailments
due to the same medication.
Unfortunately, this is not our first experience seeing pharmaceutical drugs
causing serious injury or death to unsuspecting users of the drug. Take
a look at our other pages on
dangerous drugs in general to get some idea of other instances of drug manufacturers who failed to
adequately warn people of the potential dangers of their drugs, and the
harmful consequences that followed.
If you’ve taken Elmiron for at least two years, and you’ve
noticed yourself having vision problems or have been diagnosed with maculopathy
or any other vision issues, call our attorneys at Law Offices Cytryn &
Velazquez, P.A. at
(954) 833-1440 today for a free consultation.