InDEPTH with Brad Byrd: Sudden Recall

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Recently, the drug Natpara was recalled by pharmaceutical company, Takada. It’s used to treat hypoparathyroidism.

Sandy Keneipp, who lives in Sumner, Illinois, says she wasn’t given any warning and her life is in danger.

Eyewitness News’ Brad Byrd goes in-depth with Sandy Keneipp and Evansville Dr. David Schultz to talk about the drug recall and what it means for her.

FULL TRANSCRIPTION:

Brad Byrd: Welcome to in-depth: I had never heard of the drug called Natpara made by pharmaceutical company Takada. It is used to treat hypoparathyroidism. But now I have. It is a drug that was recalled by Takada in September. A Tri-State woman says she was given no warning this was coming and that her very life is in danger. Her name is Sandy Keneipp. She lives in Sumner, Illinois. She joins me tonight with Evansville Dr. David Schultz a primary care doctor in Evansville, who is well versed on why our thyroid health is so important. And Dr. Schultz is not Sandy’s doctor, but he can enlighten us on the importance of thyroid health. Sandy, this started with a surgery. Tell me about that.

Sandy Keneipp: It did. It started when I went in for a check up with my insurance actually. My doctor said he felt something on my thyroid and immediately sent me to an ENT. He checked me out and less than a month later, I was having surgery and they were removing my thyroid.

Brad Byrd: Ok, and then the paras were removed.

Sandy Keneipp: Yes, he told my husband he had to take two out there were imbedded in my thyroid out, but he left two of them in there and they would wake up – usually – within six months.

Brad Byrd: Is that common Dr. Schultz?

Dr. David Schultz: It is. It’s a standard technique to operate on the thyroid gland and if there is erective parathyroid to remove those as well and generally speaking physicians will even remove all four and replant one in the forearm.

Brad Byrd: And what do they do for the body?

Dr. David Schultz: Well, there’s two glands in the neck; the thyroid gland and the parathyroid gland. The parathyroid glands are four glands on top of the thyroid gland and the parathyroid gland is important for regulation of calcium. So, with the parathyroid, the parathyroid gland secretes parathyroid hormone, which raise calcium and sustain calcium and Vitamin D in your body.

Brad Byrd: Sandy, you got a letter in the mail, but you say you got this news on Facebook?

Sandy Keneipp: Yes.

Brad Byrd: And what news was that?

Sandy Keneipp: I literally heard on one of my Natpara groups that they had recalled it. No one had contacted me, I just literally heard it on the Facebook page first.

Brad Byrd: Then you did get the call?

Sandy Keneipp: We did get the letter 6 days after it was recalled.

Brad Byrd: And then about 2 weeks later another letter came? Read that paragraph right at the top, the one dated September 25th.

Sandy Keneipp: We recognize that the Natpara recall in the U.S. has been extremely difficult for patients, families and caregivers. Since this began on Sept. 5, 2019, our team has been working diligently with the FDA on a number of potential solutions to bring this critical medicine back to patients.

Brad Byrd: You say critical medicine so, how do you feel now? You told me you basically have stopped taking it.

Sandy Keneipp: I ran out of my 75 vile on Saturday night/Sunday morning.

Brad Byrd: How do you feel?

Sandy Keneipp: So, I take a lot of calcium and calcitriol and a lot of other medicine just to get me up. And right now, I’m doing ok. My kidneys are killing me already and it’s only been 3 days so, it’s probably not gonna end good.

Brad Byrd: Dr. Schultz a lot of people probably don’t understand that calcium and the thyroid are so closely linked, tell me about that.

Dr. David Schultz: The parathyroid hormones are secreted by the parathyroid gland and it can increase and help sustain your calcium levels. Without parathyroid hormone, your calcium levels plummet. And traditionally in the past the only thing we’ve had to treat hypoparathyroidism is actually just taking elemental calcium and Vitamin D and that’s it. The problem with that is that there are a lot of people who are resistant to that where the calcium levels don’t stay up or they’re having to take such a large amount of calcium that it places them at very high risk for developing problems in the brain, with memory, with focus and also with kidney stones.

Brad Byrd: Kidney stones obviously with the calcium itself. This is not a situation where you drink a ton of milk and you’re going to be feeling better.

Sandy Keneipp: No, I drink milk, I eat cottage cheese, but I do whatever I can.

Brad Byrd: You did contact this company. What response did you get?

Sandy Keneipp: They tell me the same thing they told me the day I contacted them after seeing it on Facebook. We’re working closely with the FDA to get this back out to you.

Brad Byrd: Is there any alternative? Has your doctor given you any alternative prescription-wise that you could take?

Sandy Keneipp: Nope. There’s nothing to replace Natpara.

Brad Byrd: So, what’s the diagnosis for you then?

Sandy Keneipp: Well, I’m probably gonna end up in the hospital like I was before I got on Natpara. Hopefully, they make me a room up there, I don’t know.

Brad Byrd: Dr. Schultz, you tell me these recalls come out of the blue, how common are they?

Dr. David Schultz: Well, we’ve seen several recalls over the year. As people recall Vioxx, Bextra – very important drugs were recalled over the years and many, many others. And this is quite troublesome for us because we have – as physicians – very little warning this is going to happen. And then we’re scrambling to get our patients on the right medications.

Brad Byrd: And Sandy, you were in pretty bad shape before you took Natpara, tell me about that.

Sandy Keneipp: I spent a lot of time at Wabash General Hospital – they did have to transfer me over to Deaconess a couple times, just because I was that critical. I don’t know I hope there’s a medicine that comes through and Natpara comes back on before that happens to me again.

Brad Byrd: Dr. Schultz, I know she isn’t your patient, but what do you tell your patients when a drug is literally taken away with no warning? What’s the alternative for people like Sandy?

Dr. David Schultz: It’s very difficult sometimes because as physicians we’re trying to do what’s best for our patients. And sometimes when we don’t have what’s best, it sometimes places us at a disadvantage. But always as physicians we have to have plan B, and C and sometimes even D for our patients and unfortunately, without Natpara, there’s not a lot of plans out there. So, it’s very important, in her case, to monitor her calcium levels, at least monitor it monthly and monitor renal function.

Brad Byrd: And Sandy, you’re not alone, you’re in a closed Facebook group. How many people are in that group?

Sandy Keneipp: There’s 2,700 of us.

Brad Byrd: 2,700 and they’re basically in the same dilemma that you’re in.

Sandy Keneipp: Yes, every one of them.

Brad Byrd: That’s very important support group then. What are you going to do then?

Sandy Keneipp: I’m going to pray to god that something happens. I’ll keep you posted.

Brad Byrd: Well, Dr. David Schultz thank you for being here tonight and talking about this and Sandy, best to you, I hope this takes a turn for the better.

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(This story was originally published on November 6, 2019)

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