Rare Daily Staff
Takeda said it has issued a recall for all doses of Natpara, a parathyroid hormone used to treat patients with hypocalcermia in patients with hypoparathyroidism.
The company said the recall is due to the potential for small rubber fragments, originating from the rubber septum, to detach and enter the Natpara cartridge. During the 14-day Natpara treatment period, the septum is punctured by a needle each day to obtain the daily dosage of medicine solution.
Takeda sent letters to patients and healthcare providers alerting them to the recall following discussions the company had with the U.S. Food and Drug Administration.
Natpara is a parathyroid hormone indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism.
Patients are instructed to contact their prescribing healthcare provider. The company is warning patients and providers that stopping use of Natpara abruptly can cause a sharp decrease in blood calcium levels, which can have serious health consequences.
Patients should be under close supervision by their healthcare providers to discuss individual treatment plans, 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.