November 12, 2021
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6:10Now PlayingVia America’s Lawyer: 15 million Americans suffer from heartburn and have turned to Zantac as a popular relief aid. But the FDA recalled the drug last year, and a class-action lawsuit against manufacturers is on the horizon. From the Mass Torts Made Perfect conference in Las Vegas, attorney Madeline Pendley joined RT’s Brent Jabbour, filling in for Mike Papantonio, to explain how the makers of Zantac have spent decades sweeping serious cancer risks under the rug.
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*This transcript was generated by a third-party transcription software company, so please excuse any typos.
Zantac has been one of the most popular over the counter heartburn medications in America for years now, but recently serious dangers were revealed and now the lawsuits are starting to come against the drug manufacturers. At a Mass Torts Made Perfect conference, RT host Brent Jabbour, talked with attorney Madeline Pendley about what's happening.
Over 15 million Americans who take Zantac are at risk of developing cancer. There's a lot to discuss here. So joining us now to do so is Madeline Pendley. Maddie, explain what the situation with Zantac is.
So basically these, these pharmaceutical companies, namely GSK, Sanofi, Pfizer and Boehringer Ingelheim, they have manufactured Zantac for basically since the 1980s. And there were studies going back to late seventies, early eighties that showed this medication could break down and facilitate cancer development. So each company is involved at different time points in that range, but basically they all knew that this could be a risk of the medication and they sold it anyway.
So what is NDMA? What is this chemical compound exactly?
So it's, it's in a family called nitrosamines. Most all nitrosamines are carcinogenic or at least have the ability to be at the right dose. So NDMA is extremely carcinogenic in animal studies. It is basically able to facilitate tumors anywhere it's exposed to an animal in lab studies and that's actually the only purpose NDMA has today is laboratory testing to study tumors.
So why is it, was it allowed to be in these medications?
No, and it's not supposed to be there. And so essentially with Zantac, what we're seeing is it's called a design defect from the legal realm. It means that the way the ranitidine molecule is designed, ranitidine being the active ingredient in Zantac, it facilitates the breakdown into NDMA. So to put it really simply and my science folks are going to freak out, but the simple, the simple analysis is ranitidine contains both the N and the DMA in the molecule. So once it's exposed to things like heat and humidity, it breaks down into NDMA.
And so, how much did the manufacturers know about this?
They knew a lot, especially GSK. So GSK is the company who actually invented the ranitidine molecule. So they did years of studies prior to putting it on the market, prior to submitting it to the FDA, in which they saw what's called nitrosation, which is ranitidine breaking down into NDMA. In human body studies in animal studies, in test tube studies, outside the human body, they could see that this was breaking down, but they kind of just explained it away saying, well, this won't really happen in real life, but it does and it did.
And did regulators step in at all and, or have they stepped in on this?
At this point, yes. In April, 2020, the FDA did finally say, okay, we need to do something about this. We're going to pull all the Zantac from the market. So October, 2019 to back up a little bit, there was a study that came out that alerted everybody to the potential issue. There were some issues in the way they tested Zantac. So, you know, the FDA pushed back, the manufacturers pushed back and said, this is not really happening. Come April, 2020, they realized it was and so it was all pulled from the market.
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