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Label Changes for:

Natpara (parathyroid hormone)

June 2016

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

June 2016

WARNINGS AND PRECAUTIONS

Hypercalcemia
  • In the pivotal trial, 3 patients randomized to NATPARA required administration of IV fluids to correct hypercalcemia during treatment with Natpara. The risk is highest when starting or increasing the dose of NATPARA, but can occur at any time. (updated sentences in paragraph)
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