COVID-19 Update: How We Are Serving and Protecting Our Clients

Articles Tagged with Food and Drug Administration

FDA-300x123

Elmiron is a pentosan polysulfate sodium, which is used to treat interstitial cystitis or “painful bladder syndrome.”  Painful bladder syndrome affects more than a million people in the United States by causing chronic pain in the bladder and pelvis areas.  Currently, Elmiron is the only prescription pill approved by the Food and Drug Administration (FDA) to treat painful bladder syndrome.

Following the FDA’s 1985 approval of Elmiron, Janssen Pharmaceuticals, a division of healthcare giant Johnson & Johnson, began production and distribution.  Elmiron has been open about known side effects, such as hair loss, bruising, diarrhea, gastroesophageal reflux, headaches, skin rashes, and sleep disorders.  However, studies completed in 2018 and 2019 determined that up to 25% of individuals who used Elmiron over an extended period of time developed vision loss and damage to their eyes, which has raised concern over whether the drug is safe.  The condition caused by Elmiron is referred to as “pigmentary retinal maculopathy of unknown origin.” Although maculopathies are fairly common conditions, the one seen in Elmiron patients is so rare, it was given its own name and its cause is referred to as “unknown origin.”

If these symptoms or circumstances sound familiar to you, you should immediately schedule a visit with a medical expert.  Vision loss, retinal damage, and dark spots on your retina may be signs of adverse impacts of Elmiron.  The more exposure an individual has to Elmiron, the more likely they are to develop serious vision issues.

Contact Information