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The Zantac® Controversy

April 13 2020 | Blog
  • A popular heartburn drug has been singled out by the FDA resulting in more than a dozen recalls. Read our blog to learn which ranitidine-based medications have been affected, what the controversy is all about, and what legal consequences this may incur.

    Zantac® is a well-known drug that has been available and widely sold on the American market for decades. By the late 1980’s, it had already become the go-to heartburn medicine for many of the some 60 million Americans who experience heartburn at least once a month. According to data from 2019, doctors all over the country write 15 million prescriptions for ranitidine⁠–the active ingredient in Zantac® and similar drugs⁠–each year. Meanwhile, it is estimated that millions more take the drug in its over-the-counter versions.

    As shown by statistical data, ranitidine has been on the list of the 100 most-prescribed drugs for well over a decade. More than a few times since 2007, it ranked 50th or higher on that list, indicating the enormous popularity of this drug. One of the reasons why Zantac® and its generic counterparts were so popular was that these medications were largely perceived as safe. For example, one meta-analysis ⁠–a study that aggregates and compares the result of a large body of other scientific investigations- attested that “data from a large population of controlled clinical trials…confirmed the excellent safety profile of ranitidine.”

    In the past few months, however, that perception has dramatically changed. There was an announcement issued by the Food and Drug Agency (FDA) in September 2019, warning health care professionals and consumers about dangerous levels of a carcinogenic substance found in samples of ranitidine. Since then, more than a dozen drug companies have recalled their generic ranitidine drugs.

    NDMA Found in Ranitidine Samples

    In an announcement published on September 13, 2019, the FDA warned the public that it had discovered low-level amounts of a substance called N-nitrosodimethylamine (NDMA) in some ranitidine medicine, including Zantac®. This was concerning since NDMA is classified as a potential human carcinogen or, in other words, a substance that can potentially cause cancer.

    NDMA is considered to be “a known environmental contaminant” that is present in many food products including “meats, dairy products, and vegetables,” and even in water. While it may have the potential to cause cancer when ingested regularly over a large period of time and in considerable quantities, a small exposure to it is not generally considered dangerous. According to the FDA, an acceptable daily intake of the substance is 96 nanograms. Unfortunately, some ranitidine drugs showed levels of NDMA exceeding this limit when tested.

    Even though the amount of NDMA varied from sample to sample and according to the testing method, a few manufacturers of ranitidine-based drugs almost immediately took action and announced voluntary recalls of their products. To date, these manufacturers include:

    • American Health Packaging
    • Amneal Pharmaceuticals, LLC
    • Apotex Corp.
    • APPCO Pharma LLC
    • Aurobindo Pharma USA, Inc.
    • Dr. Reddy’s Laboratories Ltd.
    • Denton Pharma, Inc. (dba Northwind Pharmaceuticals)
    • Glenmark Pharmaceuticals, Inc.
    • Novitium Pharma
    • Perrigo Company plc
    • Precision Dose Inc.
    • Sandoz US

    If you previously purchased and consumed ranitidine medicine that you may still have at home, check whether the manufacturer of your drug matches any of the ones mentioned above. If you do find a match, you may note that the FDA doesn’t directly mandate that you discard the drug although you may choose to do so.

    The FDA does, however, make the following recommendation: “Patients taking prescription ranitidine should speak with their health care professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA. To date, the FDA’s testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).

    Legal Ramifications of the Controversy

    If you’re worried about your prescriptions, you’re not alone. As reported, consumers all over the US are wondering whether their regular intake of Zantac® and other ranitidine drugs over a period of many years has contributed to their developing cancer. In addition, several lawsuits claiming a link between Zantac® consumption and cancer have already begun to emerge with the first one filed as early as September 2019 in Florida.

    According to product liability laws, drug manufacturers and even drug distributors may be held liable for any adverse health conditions caused by a drug with dangerous side-effects that were unknown or undisclosed. In order to receive compensation, then, a person injured by a dangerous drug must prove in court that the manufacturer was negligent.

    In the case of dangerous drugs, negligence may include:

    • The drug had dangerous side-effects of which the manufacturer was aware and yet did not disclose, or side-effects of which the manufacturer reasonably should have known.
    • The manufacturer knew about a dangerous side-effect yet failed to include a proper warning.
    • The manufacturer engaged in deceptive marketing practice, advertising the drug as a remedy for conditions it doesn’t treat, which led to negative and adverse health effects.

    Currently, it is still too early to evaluate whether any of the manufacturers of ranitidine-based drugs were negligent in any of the ways mentioned above or in another way–although it is a viable possibility. As of yet, a definite link between NDMA impurities in ranitidine medications and cancer has not been scientifically established, but research into the subject is likely to continue.

    If you have developed cancer which you suspect may have been caused or aggravated by your regular ranitidine use, it may be advisable to contact an experienced drug injury lawyer. You can schedule a free personal consultation with the Hughes & Coleman legal team to discuss this issue and your legal options.

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