Drug Safety Alerts

NATPARA® (parathyroid hormone) Class I Recall

10/02/2019

On October 2, 2019, the United States Food and Drug Administration (FDA) classified the NATPARA^® recall as a Class I due to the potential risk of rubber stopper particles clogging the needle and leading to a concern for under-dosing. In response to the FDA classification, Takeda is instructing patients with product on hand to return it directly to Takeda to prevent the use of recalled product.

Takeda continues to work closely with the FDA regarding NATPARA and values the FDA collaboration and feedback as they work together to resupply NATPARA to patients who need it.

Prior Communication:On September 5, 2019, Takeda issued a recall of NATPARA^® (parathyroid hormone) for Injection (25 mcg, 50 mcg, 75 mcg, and 100 mcg). The recall was initiated after discussion with the FDA and was effective immediately due to a potential issue related to rubber particulates originating from the rubber septum of 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 NATPARA solution. When the septum is repeatedly punctured, it is possible that small rubber fragments may detach into the cartridge.

A complete list of the affected product is provided here:

Takeda communicated directly with healthcare professionals, patients, and specialty pharmacies in the US regarding the actions required as a result of the recall. Consistent with the product labeling, Takeda alerted NATPARA patients and prescribers that discontinuing NATPARA abruptly can cause a sharp decrease in blood calcium levels (severe hypocalcemia) which can result in serious health consequences.

It remains critically important that patients contact their prescribing healthcare provider immediately 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). 

Takeda has advised that the safety profile of NATPARA remains consistent with the product label.  Takeda is working closely with regulatory agencies in relevant markets outside of the US where NATPARA is available.  NATPARA continues to be available in these markets. Takeda reports that it is working closely with the FDA to resolve the issue and resume supply as soon as possible. 

NATPARA, a recombinant human protein with the full length 84–amino–acid sequence of endogenous parathyroid hormone (PTH), is 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).

Takeda is contacting prescribers and patients directly concerning this recall. If a patient is not contacted by Takeda, the patient should contact Takeda at 1-866-888-0660.

Healthcare providers with medical-related questions or other questions about the NATPARA recall should contact Takeda Medical Information at 1-800-828-2088 and select Option 2.  For full prescribing information, including warnings and precautions, please visit https://www.shirecontent.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the US FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

CVS Caremark Response:

Please note: These products are not carried by the CVS Caremark® Mail Service Pharmacies. These products are carried by the CVS Specialty^™ Pharmacies only. Because of this action, CVS Specialty sending letters to members who received this product through CVS Specialty Pharmacy and their physicians.

For more information about this recall, please contact Takeda at 1-866-888-0660 or visit https://www.takeda.com.

You may also call the United States Food and Drug Administration (FDA) at 1‑888‑INFO‑FDA (1‑888‑463‑6332).

To view the FDA notice regarding Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, please click on the link below: https://www.accessdata.fda.gov.

To view the FDA notice regarding Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges, please click on the link below: https://www.accessdata.fda.gov.

To view the FDA notice regarding Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartridges, please click on the link below: https://www.accessdata.fda.gov.

To view the FDA notice regarding Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartridges, please click on the link below: https://www.accessdata.fda.gov.