MOUNT CARMEL – For a small number of people around the country, hypoparathyroidism is a disorder that they deal with everyday.
Hypoparathyroidism is a condition where an individual’s body does not secrete enough parathyroid hormone (PTH). Without enough PTH, the body is unable to properly regulate phosphorus and calcium in the blood. This malfunction causes an affected individual to have abnormally low calcium levels with abnormally high phosphorus levels. The parathyroid glands in the neck are responsible for secreting PTH. Hypoparathyroidism patients have parathyroid glands that do not function properly.
But for many of these people, including Sandy Keneipp of Mount Carmel, a drug called Natpara was available for them that helped lessen the effects of the disorder, until recently.
Natpara was recently pulled from the market by the FDA, due to the potential of a rubber particulate in the injectable medication.
Keneipp began to deal with her issues a couple of years ago.
“In July of 2017 I went in for a routine check-up for my insurance with Dr. Jani and he said he felt something on my thyroid,” Keneipp said. “He sent me to Evansville to see a doctor. In August, he took my thyroid out. My thyroid had goiters on it and it was affecting my swallowing a bit. I had a biopsy, but it came back clear.”
Along with the thyroid, the doctor removed two parathyroids. Keneipp was told that the other two parathyroids were 'asleep' but they would begin working to replace the two that were removed and she would be ok.
Keneipp spent 11 days in the hospital, receiving calcium infusions the whole time, which caused blood clots.
“I was released at 4:20 p.m. and at 5 a.m. the next morning I was being rushed back because I had no calcium in my body,” she said. “Donna Jackson (RN, Wabash General Hospital) actually saved my life that day. I then was taken by ambulance back to Evansville because when you have calcium problems it can affect your heart and a lot of other things.”
She spent several days in ICU and continued to receive calcium infusions and was told to eat Tums as well when she was released.
“I continued to go to the hospital for infusions and decided to look online for help to solve the problem before I died,” Keneipp said. “I found a doctor in Indianapolis and he did some tests and told me I needed to go on Natpara. There are 70,000 people who have this disease, there are 2,700 of us who are critical. I am one of those that the other options didn't help. Nobody knows about the disease which is bad.”
Calcium infusions were an almost daily occurrence for Keneipp, but after taking Natpara, she was down to almost no infusions.
“I am not going to say it is the best thing in the world, because there are side effects, but it is the best thing in the world. It is that good of a hormone,” Keneipp said.
But on Sept. 5 of this year, Keneipp read on Facebook that the FDA had pulled the drug.
“Everyone else on it read it on Facebook as well, because we are in a closed group,” she said. “We were thinking that it was a bad joke. Shire Pharmaceuticals made the drug and sold to Takeda a while back. We had heard that they weren't going to keep it because they weren't making money with it. We thought they would sell it to somebody else. Nobody called us (about the recall) and said anything to us. But if we had it, we could still take it. We got a letter in the mail later.”
Keneipp said her supply will run out on Sunday. She expects she will be back to the near daily calcium infusions after that.
“I may as well get a bed up there,” she said. “With the calcium before, my kidneys were shutting down. Right now, my levels are bad, but I can't even imagine what it will be like when I am back on them. Calcitriol is not good for your kidneys. How does someone just get rid of a drug.”
Looking back, Keneipp wishes she never had the initial surgery on her thyroid.
“Within a month my life changed,” she said. “I was literally the healthiest person on Earth. It is crazy how stuff happens. I question it everyday.”
There is a special use program for one percent of those in need to stay on Natpara. To be eligible for the program, a patient must apply through their doctor. Keneipp has not yet applied for the special use.
“I don't think my doctor has applied yet for the three patients he has,” she said. “I put a call in to him to apply for me.”
U.S. Senators Patrick Leahy, Bernie Sanders and U.S. Representative Peter Welch recently sent a letter to the FDA asking for a quick response on the future of Natpara.