Bellwether Trials Could Force The FDA To Pull Elmiron Off The Market

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The FDA may soon wake up to the dangers of Elmiron and insist doctors stop prescribing it

Saturday, May 22, 2021 - Janssen Pharmaceuticals, the maker of Elmiron, has continued to leave the product on the market despite studies that link taking the drug to develop severe eyesight damage. It is also surprising that the Food and Drug Administration (FDA), has continued to allow anti interstitial cystitis (IC) drug Elmiron (pentosan polysulfate sodium), to remain on the market given that more than 200 women have filed lawsuits alleging that taking the drug has led to progressive, permanent and irreversible eyesight damage. Study after study has come out that links the drug with causing pigmentary maculopathy, the loss of vision anytime there is less than optimal lighting available. Women suffering from pigmentary maculopathy have trouble driving in the evening and at night and difficulty reading because of developing pigmented spots on the macula that resemble specks. Elmiron is manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. The company has just recently updated its product warning label and website warnings to reflect that they do not know how Elmiron works, only that a person should take the drug regularly for a few months before expecting bladder pain relief. Visit Elmiron eye lawsuits to learn more.

The FDA‘s lack of decisive action on Elmiron is surprising. The agency reacted swiftly in other cases and demanded the recall of Zantac ranitidine heartburn medicine when it was discovered the drug contained a carcinogenic compound. Johnson & Johnson also stopped selling its iconic Johnson‘s Baby Powder when lawsuits claimed the product contained asbestos and was causing cancer. Johnson & Johnson also pulled its Ethicon Physiomesh hernia repair mesh after many complaints were made to medical device regulators in Europe about the support mesh failing and retrieved with revision surgery. Elmiron vision damage seems as bad as some of these prior instances of corporate negligence and fraud. Doctors continue to prescribe the drug when bladder pain is unbearable. Elmiron is the only FDA-approved drug on the market to treat IC bladder pain, and the company failed to warn consumers of the vision damage side effects for more than 20-years during which time millions of people took the drug.

Lawsuits filed against Janssen Pharmaceuticals and Johnson & Johnson claim the company had an obligation to know that the drug caused vision damage and to warn consumers and that the drug may not even work. Some studies point out that so few people experience pain relief from taking it that the pain relief effects of Elmiron may only be a placebo. There are many other more effective ways to treat bladder pain and they are described on the Interstitial Cystitis Association (ICA)‘s website. The ICA instructs IC pain sufferers to avoid drinking or eating: "coffee (caffeinated and decaffeinated), tea (caffeinated and decaffeinated), soda, alcohol, citrus juices, and cranberry juice. Foods and beverages containing artificial sweeteners. Hot peppers and spicy foods," because these foods cause IC flare-ups. According to ICA, it may take months for a person‘s IC pain to improve. Patients should stick with the elimination diet for at least three months