Lawsuits were filed by two women against the manufacturers of Elmiron, the only FDA-approved drug for interstitial cystitis, which is commonly called, “painful bladder syndrome.” The lawsuits were filed August 12th in a New Jersey U.S. District Court, against three different companies: Janssen pharmaceuticals, which is a subsidiary of Johnson & Johnson, Bayer, and Teva. The two women, who used Elmiron for 10 years and four years, respectively, allege the drug caused vision problems.
The lawsuits claim that Elmiron manufacturers knew for decades the risks associated with the drug, but neglected to inform physicians or patients (and, presumably, federal agencies such as the FDA). It was only recently that impaired vision, particularly caused by pigmentary maculopathy was added to the drug’s package insert. The two women who filed the separate lawsuits used the drug well before the side effect was added.
According to Law360.com, in addition to the manufacturer’s intentionally neglecting to warn about potential vision problems, the complaints also claim that Janssen, et. al, aren’t exactly sure how the drugs work. Moreover, the drug has a very low bladder-absorbability rate and a high absorbability rate in the retinas. This explains why Elmiron may negatively affect the eyes with long-term use.
In addition, the women also accuse the companies that market Elmiron of false advertising. They say that although Elmiron is marketed as the only FDA-approved drug for interstitial cystitis (IC), there are four other oral medications for the condition.
According to Harvard Health, Elmiron is indeed the only FDA-approved oral drug specifically for IC. However, the following interventions may also improve the condition:
- Tricyclic antidepressants: Amitriptyline is the most common of these.
- Antihistamines: hydroxyzine (Atarax, Vistaril)
- Bladder instillations: Dimethyl sulfoxide (DMSO), Hyaluronic acid (Cystistat)
Other users of Elmiron have sued the manufacturers because of eye pain, vision loss and other vision abnormalities, including blurred vision, myopia (impaired vision at close range), and double or distorted vision.
In a statement to Law360, representatives for Johnson & Johnson said, “Interstitial cystitis is a painful and debilitating disease. ELMIRON® is the only FDA-approved oral medicine that has been helping patients suffering from this condition for more than two decades. We plan to defend against the claims made in this litigation.”
As this previous article about Elmiron lawsuits cites, there have been several studies demonstrating a link between Elmiron use and vision impairment.