When a doctor prescribes medication to treat an existing illness, patients expect the medication will aid them when they need it. Unfortunately, however, this isn’t always the case as some prescribed medications can actually cause more harm than good. Such is the case for the drug Pentosan, commonly known by its brand name, Elmiron, which has been found to cause long-term, irreversible vision problems for those who take it.
Pentosan is sodium pentosan polysulfate (PPS) and is sold under the brand name Elmiron. Elmiron is a medication typically used to treat various conditions such as interstitial cystitis (IC), urinary tract infections (UTI), and osteoarthritis. Its most common use is to treat the pain caused by interstitial cystitis, a type of bladder syndrome. Janssen Pharmaceuticals manufactures the drug, which was approved for sale under the Orphan Drug Act (ODA) in 1996 by the U.S. Food and Drug Administration (FDA). The ODA allows for special status as well as incentives to the manufacturers of medications that treat rare diseases. Elmiron has sales of over $150 million a year.
Elmiron is currently the only oral drug approved to treat the bladder pain typically associated with IC. Furthermore, it is not available over the counter and there is no current generic version. Most Elmiron patients are women; and, the prescription medication is typically taken long-term. Although Elmiron is the only available medication to treat these illnesses, new reports suggest the drug is toxic to the retinas and long-term use has been linked to a number of vision disorders, including maculopathy. This is despite the drug’s website listing the only common side effects as hair loss, headache, and diarrhea, among others. You have the right to safe products and to know all of the major risks associated with what you put into your body.
Maculopathy refers to a condition that affects the macula, or the central part of the retina. This portion of the eye is associated with highly sensitive, accurate vision and shields the retina from ultraviolet and blue light, allowing us to see fine details more clearly.
In 2018, Emory Eye Center in Atlanta, Georgia reported that patients who took the standard Elmiron dosage (up to 200-400mg a day) for up to 15 years developed unusual changes in their macula. In 2019, an additional 10 patients diagnosed with IC that had been prescribed Elmiron all showed symptoms of maculopathy. Additionally, ophthalmologists from Kaiser Permanente found 24% of patients who took the drug for at least five years displayed varying amounts of eye damage.
In January of this year, doctors of the American Academy of Ophthalmology reviewed data for 117 patients with IC who took the drug and found 27 had definite signs of maculopathy. Those who took more than 1,500mg had the highest risk of toxicity. The findings provided “strong support” of previous studies linking long-term Elmiron use to toxic maculopathy.
Unfortunately, studies have determined that even after patients discontinue taking the drug, progressive damage to their vision continues, including:
Scientists have discovered that the greater the quantity of Elmiron taken, the more significant the resulting eye damage. In the later stages, eye disorders like these can mimic dry atrophic age-related macular degeneration that typically results in permanent vision loss.
Investigations into Elmiron suggest Janssen Pharmaceuticals may have known about the connection between using the drug and its effects on the eyes for decades. These findings have left Janssen Pharmaceuticals under major scrutiny as lawsuits begin to mount with regard to major vision issues caused by long-term use. Plaintiffs accuse the pharmaceutical company of failing to warn the public about the risk of potentially permanent vision loss from taking Elmiron. As more and more patients begin to come forward, it’s important that they seek legal counsel from an experienced product liability attorney.
No patient should fear taking a drug prescribed by a medical professional would cause them to develop a devastating condition such as maculopathy. When the side effects of dangerous drugs injure trusting consumers, it can cause lasting effects on the patient and their loved ones. At Ramsey Law Group, we understand the shortcuts drug companies take in order to make maximum profits off of those in need. If you or someone you know has taken Elmiron and suffered maculopathy or another lasting vision issue, contact us today to discuss your case.