The drug recall that rocked the hypoparathyroidism community

There’s a quote by Chicago Tribune columnist Mary Schmich that was later popularized by one of my favorite film directors, Baz Luhrmann, and that repeats in my head during shocking moments: “The real troubles in your life are apt to be things that never crossed your worried mind, the kind that blindside you at 4 p.m. on some idle Tuesday.”

Thanks to the popularity of Luhrmann’s spoken word adaptation, which hit my radio the same year I started high school, this quote has become a lifelong reminder that no matter how much I worry, I can’t control or predict life’s most terrifying moments. Sept. 5, 2019, was one of them.

It was a beautiful fall evening, dry and still warm. I was in a coffee shop with my writer friend, working on my upcoming book release. At 8:58 p.m., a Facebook message popped up on my phone with a link to an article stating that my current medication, Natpara (recombinant human parathyroid hormone), was recalled in the United States. The recall was initiated because of a breakdown of the vial’s rubber septum when punctured repeatedly with a needle.

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At the time, Natpara was the only medication approved by the U.S. Food and Drug Administration (FDA) for my rare disease, hypoparathyroidism, often referred to as hypopara. The action meant I was one of around 2,700 people about to lose the medication that kept us functional.

I don’t remember the drive home, but I do remember walking into my house and sitting on the floor, staring at the wall for an indeterminate amount of time.

For days, I couldn’t sleep, couldn’t eat.

Weathering the loss

Group texts among hypopara friends left us all asking more questions. My daily calls to the FDA and Takeda Pharmaceuticals (Natpara’s manufacturer) were met with sympathy, but no information. Boxes were sent to patients, asking them to send their remaining drug supply back to Takeda.

Patients reached out to news outlets and politicians alike, begging for attention on the issue. U.S. Sens. Bernie Sanders and Patrick Leahy and Rep. Peter Welch, all of Vermont, sent a letter to the acting FDA commissioner, urging him to provide an update on a recall resolution. (Leahy has since retired, and Welch is now a senator.)

As patients’ medication ran out, social media support groups resembled battlefields, with post after post of patients being hospitalized after discontinuing Natpara, their calcium plummeting.

Some found they needed significantly more calcium supplements and calcitriol (1,25-dihydroxyvitamin D3, often known by its brand name Rocaltrol) — a medication that helps regulate calcium and phosphate in the body — than they’d needed before starting Natpara. Without an at-home calcium tester, patients were guessing what their calcium level was based entirely on symptoms, risking such serious side effects as seizure and bronchospasms.

I was terrified about what would happen when my medication ran out.

Michael Mannstadt, a Harvard researcher and hypoparathyroidism specialist, released a series of posts with guidance about the situation, including an insurance letter to try and gain emergency coverage for the injection Forteo (teriparatide). This short-acting osteoporosis medication could be used off-label to provide calcium stability, often through multiple daily injections.

Because Forteo is FDA-approved for osteoporosis and not for hypopara, several insurance companies refused to cover it, despite the recall. Without insurance, Forteo was estimated to cost $30,000 a year at the time.

We were left with few options.

Nineteen days after the recall, Takeda announced the Natpara Special Use Program, intended to support patients who were facing life-threatening complications upon discontinuing the medicine. While the initial program expected only a small number of participants, around 420 people were approved.

On the Special Use Program, I received one 14-day vial for each dose to prevent multiple needles puncturing the rubber septum. I then returned every vial for compliance inspection.

One month into the program, I received a letter that the 100-mcg vials were experiencing a manufacturing issue because of protein particle formation, and there would be a potential shortage. This manufacturing issue persisted throughout the program and was eventually part of the reason Takeda discontinued Natpara (known as Natpar outside the U.S.) worldwide in December 2024.

I was lucky to be the first patient to transition from the Special Use Program to the Yorvipath (palopegteriparatide) Expanded Access Trial in June 2023. I’m currently the most stable I’ve been since my diagnosis 22 years ago. I’m thankful that with Yorvipath’s FDA approval, the hypopara community has finally found relief from the recall that blindsided us all.

Yorvipath, however, is currently the only FDA-approved treatment for hypopara. My hypopara friends and I still look over our shoulders, hoping that nothing happens to this medication before another one comes to market. I don’t think many of us will take a full breath until more than one option is available and we know that our lives won’t be completely upended again from a hypopara medication recall on “some idle” Thursday.

Note: Hypoparathyroidism News is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Hypoparathyroidism News or its parent company, Bionews, and are intended to spark discussion about issues pertaining to hypoparathyroidism.