Is Parathyroid hormone safe?
Trial data and osteosarcoma boxed warning
Common adverse events in REPLACE were tingling and numbness, headache and nausea. Both high and low calcium occurred, mostly during dose adjustment. Low calcium after a missed dose could be abrupt, because patients had cut their supplements. The boxed warning for osteosarcoma comes from rat studies of lab-made versions of PTH. No human cases were blamed on the drug. But the FDA limited it to patients who could not be managed otherwise. It also required enrollment in a risk-management program. 1
The 2019 US recall was a manufacturing problem. Rubber particles shed from the cartridge septum into the drug. Takeda was unable to fix it. In October 2022 it said it would stop manufacturing worldwide at the end of 2024. It would not return the product to the US market. Existing patients would get remaining doses under a special-use program until stock ran out. 2
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Citations
- Mannstadt 2013, Lancet Diabetes Endocrinol: efficacy and safety of recombinant human parathyroid hormone (1-84) in hypoparathyroidism (REPLACE) doi.org
- Takeda 2022: statement on discontinuing manufacturing of Natpar/Natpara at the end of 2024 takeda.com
Reference information only, not medical advice. Drawn from the Parathyroid hormone article, fact-checked against the cited sources. No dosing anywhere on this site.