The U.S. Food & Drug Administration (FDA) placed Elmiron on its so-called “Watch List” earlier this year, reflecting growing concerns that the bladder pain medication could be causing some patients to develop severe vision problems.
According to MedScape, the Watch List is generated from the FDA’s Adverse Event Reporting System. Elmiron was one of 15 prescription medications that made the list in January 2020, with the agency indicating it was “evaluating the need for regulatory action” because of a possible association with eye disorders.
Its appearance on the list doesn’t mean the FDA has concluded Elmiron causes vision problems, only that a potential risk has been identified. The agency will take action — changes to labeling, restricting the drug’s use, or (very rarely) removing it from the market – if its evaluation ultimately confirms a safety issue.
Other notable drugs that made the FDA Watch List in January included the chemotherapy drug Cisplatin for a possible link to aortic thrombosis; eight fluoroquinolone antibiotics, including Levaquin, Cipro and Avelox, for a possible risk of mitral and aortic regurgitation; and certain HIV treatments, including Biktarvy, Genvoya, and Descovy, for kidney toxicity.
Elmiron (Pentosan polysulfate sodium) is the only FDA-approved medication indicated to relieve bladder pain and discomfort associated with interstitial nephritis. In recent years, however, a growing number of studies have suggested patients treated with Elmiron may be more likely to develop maculopathy, a class of eye disorders that affect the macula, the part of the retina associated with highly sensitive and accurate vision.
Most recently, a case study published in Ophthalmic Surgery, Lasers and Imaging Retina last November suggested that Elmiron-induced maculopathy could even continue long after treatment ended. The report involved a 69-year-old woman who stopped using the medication at the age of 62, following a diagnosis of maculopathy. Subsequent eye exams at age 67 and age 69 showed the degeneration continued to progress, even though she was no longer being treated with Elmiron.
There are different types of maculopathy. The form most commonly associated with Elmiron is called “pigmentary maculopathy of unknown etiology.” Many experts are now recommending that all Elmiron patients undergo ophthalmic examinations for early detection of pigmentary maculopathy, particularly long-term users.