What You Need to Know
After discussions with the FDA, Takeda issued a US recall on September 5, 2019, for all doses of NATPARA® (parathyroid hormone) for Injection (25 mcg, 50 mcg, 75 mcg, and 100 mcg).
NATPARA is a parathyroid hormone currently approved in the US as the only adjunctive treatment for adult patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone (calcium and vitamin D).
With patient safety as the company’s main priority, Takeda is communicating directly with US healthcare professionals as well as with patients and specialty pharmacies. Discontinuing NATPARA abruptly can cause a sharp decrease in blood calcium levels (severe hypocalcemia) which can result in serious health consequences. It is critically important that patients contact their prescribing healthcare provider to discuss their individual treatment plan and ensure close supervision, including frequent monitoring of blood calcium levels and close titration of active vitamin D and calcium supplements upon stopping NATPARA to avoid low blood calcium (hypocalcemia).
All of us at Takeda understand the impact that this recall has on patients, and we are continuing to work closely with the FDA until we are able to resolve the issue. Takeda values the US FDA’s collaboration and feedback as we work together to resupply NATPARA to patients who need it.
If you have questions or concerns about this recall, browse the information on this page. For more details, read our PDF. Be sure to bookmark this page and check back often for the latest updates.
Letter to HCPs
Updated FDA Classification
Special Use Letter for HCPs
Special Use Program
NATPARA Special Use Program
Takeda has worked with the FDA to develop a Special Use Program for NATPARA. The program’s intent is to allow access to the drug by patients facing severe health consequences due to the inability to receive NATPARA. Physicians can submit a request to Takeda explaining the patient’s severe and/or life-threatening medical situation. An adjudication committee will review the requests on a case-by-case basis. Physicians who believe they have a patient meeting this criteria should email Takeda at NatparaSpecialUseProgram@Takeda.com. Download the PDF for full details.Get Details