September 6, 2019 – Takeda Pharmaceuticals has voluntarily recalled all doses of Natpara® (parathyroid hormone) for injection due to the potential for rubber particles to break off from the rubber septum of the Natpara cartridge.
Natpara, which is indicated to control hypocalcemia in patients with hypoparathyroidism, requires a 14-day course of treatment. The rubber covering, or septum, of the Natpara cartridge must be punctured each day to draw the drug into an injector. These repeated punctures can cause small pieces of rubber to break off into the drug solution, creating a potential hazard for patients.
In accordance with prescribing guidelines, Takeda has advised patients and prescribers against abrupt discontinuation of treatment with the Natpara. Doing so can cause a sharp decrease in blood calcium levels (severe hypocalcemia), which can result in serious health consequences. Patients should contact their prescriber 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 discontinuation of the drug.
Healthcare professionals with questions regarding the recall should contact Takeda Medical Information at 1-800-828-2088 and select Option 2. Patients with recall questions should contact OnePath at 1-866-888-0660. Adverse events that may be related to the use of the recalled product can be reported to the U.S. FDA’s MedWatch program. Additional recall details can be found on Takeda’s website.
Natpara is available only through a Risk Evaluation and Mitigation Strategy (REMS) program. The recalled product has not been dispensed by Benecard Central Fill.