As a histamine-2 blocker, ranitidine (or Zantac) was a popular pharmaceutical drug used to treat heartburn, stomach ulcers, and numerous other painful gastrointestinal ailments. While that all sounds positive and beneficial, Zantac was unfortunately found to contain a cancer-causing impurity known as N-Nitrosodimethylamine (NDMA).
This discovery led the Food and Drug Administration (FDA) to finally recall the drug from the market this past April, but before that moment, it was one of the best selling OTC drugs since 1983. Unfortunately, we are well past the point of having the damage undone, but you are not without legal recourse, and here are the reasons why.
As early as 1983, there were already studies that established the link between Zantac and NDMA. These two Italian journals confirmed that when combined with certain foods (which Zantac was often taken with), the drug exacerbated the appearance of the compound and actively damaged gastric cellular DNA.
It’s not confirmed whether or not manufacturers Sanofi and GlaxoSmithKline actively knew about the risks associated with Zantac and NDMA, but the red flags were there from the outset. Conspicuously, a 1987 GSK-sponsored study on the drug did not include any active gastric models on the drug, hinting that the company may have possibly skewed the results to downplay such health risks. Either way, a driver can’t exonerate their fault if they claimed they didn’t see a warning sign, and neither should a drug manufacturer.
As Reuters reported, the FDA first approved American Zantac treatments under the impression that they would only be used as an emergency short-term ulcer treatment. While the drug had already been approved in 31 other countries, this is still a fairly telling indication that the FDA may have been hesitant to allow consumers to use the drug in large quantities.
Nevertheless, in five years, it managed to break records as the first drug to exceed $1 billion in yearly sales. Generic alternatives with the same formula were allowed to proliferate across store shelves. Even though GSK may not have known the full long-term risks associated with Zantac, enough writing was still on the wall that they should’ve given pause.
Under the law in North Dakota and numerous other states, drug manufacturers are required to list every possible health risk and side effect associated with their product. Nevertheless, Zantac’s labeling omitted any mention of NDMA, and subsequently, the possible carcinogenic risks behind it.
There’s still some debate over whether NDMA is a “probable” or definite carcinogen, but regardless, the drug is well over the FDA’s “safe limit” of 96 nanograms of NDMA a day. With a whopping 2.5 to 3 million nanograms in a single tablet, all signs lean toward gross, inexcusable negligence on the part of GlaxoSmithKline and Sanofi. If you were a former Zantac user who now suffers from cancer, you may be entitled to a lawsuit and subsequent settlement.
If you’re local, you can seek help from Fargo’s premier injury attorneys by emailing Tatum O’Brien, Tim O’Keeffe, or Sara Monson, or get in touch with the team at O’Keeffe O’Brien Lyson Foss by calling 701-235-8000 or 877-235-8002 toll-free. Your well-being and peace of mind can’t wait, so don’t wait to schedule your free case evaluation!