FDA Again Resorts To Damage Control With Major Medications

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Published on 25 Nov 2021, 16:00
Via America’s Lawyer: While Pfizer has fessed up to the inherent cancer risks of its Xeljanz pills, manufacturers of Valsartan have kept quiet about a certain ingredient that’s primarily used for rocket fuel and inducing cancer in lab rats. At the Mass Torts Made Perfect conference in Las Vegas, RT’s Brent Jabbour, filling in for Mike Papantonio, sat down with attorney Sara Papantonio to discuss ongoing litigation against both companies.

Learn more about Xeljanz lawsuits at levinlaw.com/xeljanz-lawsuit

Find out more about Valsartan lawsuits at levinlaw.com/valsartan-lawsuit

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*This transcript was generated by a third-party transcription software company, so please excuse any typos.

Recently at the Mass Torts Made Perfect conference in Las Vegas, RT's Brent Jabbour sat down with attorney Sara Papantonio to talk about the ongoing litigation of Xeljanz and Valsartan, two major pharmaceutical cases and they're killing people. These, these drugs are killing people. So they talked about it. They followed where the money goes, where it ends up. Let's take a look.
And the FDA is again, resorting to damage control, warning the public about Xeljanz a rheumatoid arthritis drug approved in 2012. Joining us now to discuss is attorney Sara Papantonio. Sara, what are they warning the public about when it comes to Xeljanz?
They're warning the public about a whole heck of a lot. Right now, what we're dealing with is we, what we've just learned, is that Xeljanz shows an increased risk in cancer, major cardiac events and blood clots. And it's no small risk. This data's coming directly from the defendants in this case, which is going to be Pfizer. And Pfizer is telling the FDA that there is a 48% increased risk in cancer after taking Xeljanz, a 33 increased risk in major cardiac events and a long running increased risk in blood clots. So you're talking about three threats with one drug, but it's not only Xeljanz that the FDA is warning about. Based on all this data that we've seen over the course of now about 10 years, the FDA has made the ultimate decision that they're going to make warnings about the entire class of drugs that Xeljanz is in. Now, those are JAK inhibitors. So it's really extending based on what they found on this research to all three different types of drugs.
So Sara, how long have these types of drugs been around that we're now learning that there's such an increased risk?
Well, the, this class of drugs has been around for awhile and they're used to treat inflammatory diseases like rheumatoid arthritis, ulcerative colitis. But Xeljanz, when it entered into the market in 2012, what the FDA said to Pfizer is you have to conduct a clinical study on this, this drug. We got to know what the risks are. So that clinical study has been going on for 10 years now and based on the results of that, the increased risk in major cardiac events, the increased risk in cancer, the increased in blood clots, the FDA is, is standing back and saying, wait a minute. This entire drug class is probably going to carry the same risks that we're seeing in Xeljanz.
And, and this is an overarching theme that we've talked about is the regulation aspect of it. The FDA approves a drug based on information provided to them by the drug company and then says, oh, and by the way, you're going to have to do some extended studies. The drug company is. I mean, isn't that a huge failure there?
Well, of course we want to know about it beforehand. Now it's we're 10 years later, the drug's been on the market for, for nearly 10 years and they're just now saying, oh wait, might be a little bit dangerous. But the really unique fact about this case is all of this information about increased risk in cancer and major cardiac events, blood clots, is coming directly from the manufacturer of the drug.

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