Takeda recently announced it is issuing a U.S. recall for all doses of its parathyroid hormone injection due to potential rubber particulate contamination originating from the rubber septum of the product’s cartridge, according to a statement released by the FDA.
After consultation with the FDA, the recall of Natpara includes the 25 µg, 50 µg, 75 µg and 100 µg doses and is effective immediately, according to the company. During the 14-day parathyroid hormone injection treatment period, the septum is punctured by a needle each day to obtain the daily dose. When the septum is repeatedly punctured, it is possible that small rubber fragments may detach into the cartridge, according to the company.
“With patient safety as the company’s main priority, Takeda is communicating directly with health care professionals, patients and specialty pharmacies in the U.S. regarding the actions required as a result of the recall,” the company states in the release. “Consistent with the product labeling, Takeda is alerting Natpara patients and prescribers that discontinuing Natpara abruptly can cause a sharp decrease in blood calcium levels, which can result in serious health consequences. It is critically important that patients contact their prescribing health care provider to discuss their individual treatment plan and ensure close supervision, with 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).”
Takeda stated the company is working closely with regulatory agencies in relevant markets outside of the U.S. where Natpara is available. The injection continues to be available in these markets.
Natpara, a recombinant human protein with the full-length 84-amino-acid sequence of endogenous parathyroid hormone, is the only adjunctive treatment for adult patients with chronic hypoparathyroidism that cannot be adequately controlled with standard therapy alone (calcium and vitamin D).
The company noted it is working with the FDA to resolve the issue and resume supply as soon as possible. The financial impact of the recall is currently being assessed in conjunction with the remediation plan.