Is Elmiron Off the Market?
Patients suffering from chronic pain associated with interstitial cystitis believed to have found a viable treatment option in Elmiron. Nevertheless, the only FDA-approved drug to treat pain associated with the condition seems to lead to a chronic eye condition. A growing body of research backs up the association of the drug with pigmentary maculopathy.
Since then, more studies have confirmed the link, and a class action lawsuit started against the producer of Elmiron for not offering a warning against the risk of developing eye conditions. The label was updated in 2020 to include a warning about the risk of eye injury. However, there is no sign of recalling Elmiron from the market.
Interstitial cystitis (IC) is a chronic condition that causes pressure on the bladder, pelvic and bladder pain. The illness has been observed more frequently in women. There are a limited number of treatment options available for those diagnosed with IC. The only drug available on the market to treat associated chronic pain with FDA approval is pentosan polysulfate sodium, also known as Elmiron. It was approved for the US market in 1996.
The drug manufactured and sold by Janssen Pharmaceuticals has an approved dosage of 100 mg three times a day.
Elmiron and Pigmentary Maculopathy
The link between Elmiron and pigmentary maculopathy is well researched and documented. It was first observed in a 2018 study that followed up on six patients treated with PPS for their IC. The study has confirmed that pigmentary maculopathy is associated with chronic exposure to PPS. In the case of the study, the exposure had a median duration of 186 months. The majority of the subjects considered difficulty reading as the most troublesome symptom.
Since then, more cases have been identified retroactively. New research has also been conducted, including a 2019 study conducted by the American Academy of Ophthalmology. One of the most recent studies dating back to 2020, further explores the possibility of drug-induced pigmentary maculopathy.
Pigmentary maculopathy is a unique eye condition tied to the IC drug. Some of the patients who used Elmiron have displayed pigmented deposits in the form of specks located in the macula. Symptoms of pigmentary maculopathy include:
- Slow adjustment to light changes
- Difficulty reading
- Dim vision
- Areas of vision loss
- Permanent loss of vision
The FDA has announced in June last year that the manufacturer company included a warning against severe eye injury on Elmiron’s label. This may serve future users, but the damage has been done to a still unknown number of people already suffering from chronic pain. Elmiron continues to be available on the market. As of yet, there seems to be no intention on the part of Janssen Pharmaceuticals to recall the drug.
Plaintiffs in the class action lawsuit for Elmiron bring accusations to Janssen Pharmaceuticals for not warning about the risk of vision impairment caused by the drug. Since September 2020 approximately 50 cases are pending in both state and federal courts. Cases are currently being overseen by Judge Wendy Beetlestone.
However, the lawsuit is still in its early stages. Lawyers are encouraging any patients who have used the drug and experienced vision-related side-effects to step forward and join the legal proceedings. Those who have experienced eye injury after taking Elmiron may seek compensation for the following and more:
- Medical expenses
- Pain and suffering
- Loss of earning capacity
- Loss of wages
- Possibly even punitive damages
To know if you qualify to participate in the lawsuit, consider some of these questions that a lawyer might ask you:
- For how long did you take Elmiron?
- What vision problems have you experienced?
- When did your vision problems first start manifesting?
Elmiron was supposed to offer a viable solution for people suffering from chronic pain associated with IC. However, in the process, it triggered pigmentary maculopathy. More and more people injured by the drug step forward and join the Elmiron class action lawsuit.