Takeda Recalls NATPARA (Parathyroid Hormone) Injection in the U.S. Due to Potential Rubber Particulate Contamination

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Takeda Announces U.S. Recall of All Dosage Strengths of NATPARA (Parathyroid Hormone) Injection (25 mcg, 50 mcg, 75 mcg, 100 mcg)On September 6, Takeda announced that it would recall all dosage strengths of NATPARA (parathyroid hormone) injection (25 mcg, 50 mcg, 75 mcg, and 100 mcg) in the United States. This recall, which is effective immediately following discussions with the U.S. Food and Drug Administration (FDA), is due to potential issues related to rubber particulates originating from the rubber septum of the NATPARA cartridge. During the 14-day NATPARA treatment period, the septum is pierced daily with a needle to obtain the daily dose of NATPARA injection. Repeated punctures of the septum may cause small rubber fragments to dislodge into the cartridge.

Takeda stated that patient safety is the top priority, and the company is communicating directly with healthcare professionals, patients, and specialty pharmacies in the United States regarding the recall. Takeda reminded NATPARA patients and prescribing physicians that abrupt discontinuation of NATPARA may lead to a sharp decline in blood calcium levels (severe hypocalcemia), resulting in serious health consequences. It is crucial for patients to contact their prescribing healthcare provider to discuss their individual treatment plan and ensure close monitoring, including frequent monitoring of blood calcium levels after discontinuing NATPARA and careful titration of active vitamin D and calcium supplements, to avoid hypocalcemia.

The safety profile of NATPARA remains consistent with the product labeling. Takeda is working closely with regulatory authorities in relevant markets outside the United States where NATPAR/A is available. NATPAR/A will continue to be supplied in these markets.

NATPARA is a recombinant human protein with the full-length 84-amino acid sequence of endogenous parathyroid hormone (PTH). It is currently approved in the United States as the only adjunctive therapy for adult patients with chronic hypoparathyroidism whose condition cannot be adequately controlled with standard therapy (calcium and vitamin D) alone. NATPARA injection is indicated as an adjunct to calcium and vitamin D to control hypocalcemia in these patients.

Takeda is working closely with the FDA to resolve this issue and restore supply as soon as possible. The financial impact of the recall is currently being assessed in conjunction with the remediation plan.

Reference Source: Takeda Issues US Recall of NATPARA® (parathyroid hormone) for Injection Due to the Potential for Rubber Particulate