According to several lawsuits, the medication Elmiron did not list a concerning vision complication once data began to demonstrate its existence. This oversight has opened a major pharmaceutical company to liability and possibly damaged many people’s eyesight.
What is Elmiron?
Called pentosan polysulfate sodium, Elmiron treats symptoms of bladder pain and pressure associated with the chronic condition interstitial cystitis (IC). Elmiron has a host of other side effects, including:
- Hair loss
- Upset stomach
- Abdominal pain
Produced by Jansson Pharmaceuticals, the drug has been on the market since 1996. Interestingly, IC is a rare enough condition that the production of Elmiron is associated with the “Orphan Drug Act,” which “gives special status and incentives” to those who produce drugs for rare diseases.
What is the “new” side-effect?
The new warning added to the medication warns that it can cause “pigmentary maculopathy.” According to Drugwatch.com, maculopathy — also called macular degeneration — is a “progressive disease that can lead to vision loss.” The description for pigmentary maculopathy describes deposits of pigment obstructing the retina. This can lead to difficulty adjusting to low-light conditions. The vision damage is permanent.
How was this new issue discovered?
Scientists studied pigmentary maculopathy for some time, but it was not until recently that researchers found a link to Elmiron. The first study of this link was published in 2018, with several follow-ups over the next year. It took Jansson until July of 2020 to add the new side effect to their drug literature.
I am on this medication; what should I do?
If you are on a specific medication with a serious side effect, it is sensible to speak with your doctor about your concerns. You should be able to direct your medical care as much as possible. However, if you believe your vision is at risk or damaged, you may need to take further steps.
Advocating for your health is difficult, but you don’t have to do it alone.