Wednesday, July 21, 2021 - International drug companies like Johnson & Johnson and others tend to forget that they have a moral, ethical, and legal responsibility to conduct ongoing drug testing to make sure that their product is not harming their patients. Elmiron lawsuits alleged that the manufacturer of the drug had an obligation to know about its vision damage side effects and warn the public sooner. Plaintiffs allege that had they known Elmiron would cause them to go blind, they never would have taken the drug. Elmiron patients are mostly women who are experiencing bladder pain difficulty after childbirth. Many of these women have filed Elmiron blindness lawsuits alleging that taking the drug repeatedly for three or more years caused their night blindness. Elmiron is an anti-viral drug that must accumulate in the blood for about three months before it becomes effective. According to the Food and Drug Administration (FDA), "Elmiron is not a pain medication like aspirin or acetaminophen and therefore must be taken continuously for relief as prescribed." Medical experts question whether Elmiron works or is just the placebo effect that causes bladder pain to subside.
Elmiron (Pentosan polysulfate sodium) was approved for sale to the public by prescription on September 26, 1996, to treat a women‘s painful bladder condition known as interstitial cystitis (IC). Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson medical group, have enjoyed a warning-free monopoly to sell Elmiron since then until June 16, 2020, when the FDA stepped in and required Johnson & Johnson to warn their patients that the drug causes eyesight damage. The FDA was forced to take action after hundreds of Elmiron patients registered complaints with the FDA MAUDA drug and medical device database, complaining of vision damage. Patients have described having developed "difficulty reading, slow adjustment to low or reduced light environments, and blurred vision." Until recently, most forms of macular degeneration were thought to be natural and age-related, but we now know that most are caused by taking Elmiron. The FDA warns: "Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of Elmiron. Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor." The updated warning on the Johnson & Johnson website stresses not to take more than the prescribed quantity of the medication.
Hundreds of thousands of unsuspecting women were subjected to the side effects of Elmiron during the delay in the failed FDA drug monitoring system. More often than not, the FDA relies on reports of adverse drug reactions before warning the public. This method of monitoring the side effects of a drug as ailments like cancer or Elmiron vision damage is inadequate because the side effects may not become apparent for years after starting a drug. Such was the case with Elmiron. Financial damages brought by lawsuits against Janssen and Johnson & Johnson could have been responsible for forcing the FDA to take action.