Farron Cousins: According to the latest statistics, nearly 100 million people living in the United States either have Diabetes or Prediabetes, making it one of the most prevalent illnesses in the United States today. As such, obviously big Pharma wants to get in on the action, they’ve got all sorts of medications out there to treat Diabetes, Prediabetes, but a lot of these medications we’re finding out now come with some very serious side effects.

Farron Cousins: I’m joined by attorney Alex Taylor to talk about some of the most recent medications that we’ve learned are causing some serious, in this case, very serious problems with patients. Of course, Alex, I’m talking about Jardiance and Farxiga, hugely popular medications.

Farron Cousins: What do we know right now?

Alex Taylor: The newest evidence that’s out right now has linked these medications to a particular condition known as Fournier’s gangrene, also known as genital gangrene or necrotizing fasciitis. Trust me, it is just as bad as it sounds.

Farron Cousins: So this is necrotizing fasciitis? We’ve heard about that on the news plenty of years. That’s the flesh eating bacteria disease?

Alex Taylor: That’s correct.

Farron Cousins: That rots away your flesh basically?

Alex Taylor: It does. Once you get this infection… and there’s a few different types of bacterias that fall under this general category, but once you get this particular problem, the only way that they can solve it is to go in and cut out the infected flesh. It’s a process known as debridement, or debridement, and it is extremely painful.

Alex Taylor: There’s a… If you catch it early, sometimes you can treat it with antibiotics but they tend to not be very effective, and once that happens, the only way to fix it is to remove the infected tissue. One thing that happens sometimes if it spreads very rapidly as you can see especially amongst men… they’re older, sometimes they have to remove parts of the genitals in order to prevent the infection from spreading and becoming deadly.

Farron Cousins: This Fournier’s gangrene, necrotizing fasciitis, this is typically something that usually just out there in the world would typically affect men I believe over the age of 40 or 50 –

Alex Taylor: Correct.

Farron Cousins: But in the Jardiance and Farxiga users, about a third of the people who come down with this condition are women. That’s one of the ways you’re kind of able to look at this and say, “Hey, there appears to be a link between these drugs and this condition because now it’s disproportionately or at least more so than it would nature, affecting women” ?

Alex Taylor: Sure. That’s definitely one of the factors that shows that there’s an increased risk. Generally speaking, in some of the large scale studies they’ve done in this disease, there was one I saw it was 1600 diagnosed cases and only 40 of them were women. Whereas amongst the recent FDA notice, there were 55 identified cases and about a third of those were women as you said.

Alex Taylor: One thing that also shows just how large the risk here is, is that in all of the other Diabetes medications that are out there on the market, from Metformin, to insulin derivatives, and other anti-diabetic medications, since 1984 there have only been 19 cases of Fournier’s gangrene reported to the FDA. That means within five years these drugs have seen three times as many reported cases as every other medication has seen in 35 years. This is a huge increase in the risk factor over any other medication that’s out there on the market.

Farron Cousins: The evidence is kind of stacking up at this point? The FDA has the complaints, they have this data. It’s all kind of been coming in for the last few years here, and Jardiance and Farxiga, these are things that we see advertised on TV quite frequently.

Alex Taylor: Sure.

Farron Cousins: To me that’s one of the biggest dangers here is because first of all, when they do the little side effects part of the ad, typically they speak that out and I think it’s a 12th grade level versus a six or seventh grade level for everything. All the good stuff about the drugs, and it’s super fast. They try to make the screen more busy to distract you but I don’t even think in this case is that they’ve said, “Hey, this could cause necrotizing fasciitis. You could lose genital tissue, you could essentially have your life thrown upside down, ruined, your body destroyed with these medications.” Because again, based on the evidence we’ve got right now, that seems to be what’s happening.

Alex Taylor: Sure. They’re never going to put it in their marketing. They’re not going to say, “Well, this drug is going to help lower your A1C blood counts, and it’s also going to probably get you a very dangerous infection in your genitals.” They’re never going to put that in the ad materials.

Alex Taylor: The FDA though has forced them to change their drug label, which is what they provide to doctors. The real question and what we’re probably going to see when we start getting into the documents from these companies is that more likely than not, they’re downplaying all of these risks to the doctors and meanwhile trying to up sell all the benefits of the drug.

Alex Taylor: One of the things that they always say with these drugs is that, it’s a novel mechanism of action, which they try to make it sound like it’s new and exciting when really what it means is it’s untested and poorly understood.

Alex Taylor: Just to give you a brief idea of what I mean by that, every other drug out there other than this class of drug, that treats Diabetes is either insulin itself or what are known as insulin sensitizers. Meaning they help the cells in your body, your liver, your pancreas, everything, absorb and create insulin. These drugs just flush the sugar right out of your system. And in doing so it results in the condition known as volume reduction, which is what we think is what’s causing these cases.

Alex Taylor: Basically your blood plasma gets thicker as you flush all of this sugar out of your system, usually through your urine. The analogy I would give is, imagine you’re watering your plants in your front yard with the hose. Well, imagine you replace the water now with motor oil. It’s thicker, it’s not going to reach all those plants, especially the ones that are further away from you.

Alex Taylor: And so what you see is that the skin cells that are hardest to reach, where the capillaries are smallest, the blood’s not getting there as much, so the tissue’s dying, but then it’s also not getting white blood cells. The infections take place and your body can’t fight them. This drug creates the condition that leads to the infection and then also prevent your body from fighting the infection. It’s making every one of these conditions, which Diabetics are already predisposed to, more dangerous.

Farron Cousins: Anybody who’s taking these medications, the Jardiance and the Farxiga, they need to talk to their doctors pretty much as soon as they can. Say, “Hey listen, I’ve heard this about this medication. Is this the best medication for me? Is this a risk I need to be taking? Or is there probably something else out there that I can take instead?”

Alex Taylor: Absolutely. Any patient that’s taking one of these medications should definitely talk to their doctor. There are a lot of Diabetes medications out there, as I’m sure you know. There are a lot of alternatives to treatment with Farxiga or Jardiance. And so any patient that is, or any person out there that is taking these medications, is concerned about these risks, should definitely talk to their doctor and see if they can find an alternative.

Farron Cousins: Sounds great. Thank you very much. Alex Taylor, thank you for talking with us. Thank you for telling us the story, and we will definitely be following up with you on this in the near future.

Alex Taylor: Thank you very much Farron.