Takeda Pharmaceuticals is recalling all doses of Natpara, a drug used to treat low blood calcium levels, amid concerns small rubber particles may enter the body through the injections. However, the drug maker is highlighting the importance that consumers not suddenly discontinue the treatment without speaking with their medical providers.
The Natpara recall was announced on September 5, due to the risk that small rubber fragments may break away from the rubber cartridge into the injectors, increasing the risk of introducing a foreign objects into the body.
Natpara is a man-made parathyroid hormone prescription, which is used with calcium and vitamin D to control low blood calcium levels among adults that also suffer from low parathyroid hormone blood levels, a condition known as hypoparathyroidism.
It is a 14-day prescription, self-administered by the patient once daily into alternating thighs. Natpara is supplied in dual chambered glass cartridges with a rubber septum that is punctured by a needle once daily to draw doses for injections.
Takeda warns the continuous puncturing of the septum may cause rubber fragments to shed into the chambered glass cartridges, which could lead to the rubber being injected into the body.
Despite the risks associated with the recalled injection, Takeda is instructing its patients to not stop using the medication until they have contacted their prescribing doctor, as sudden stopping of the medication may result in severe or life-threatening consequences.
The recall includes all lots of Natpara Injections manufactured by Takeda Pharmaceutical Company in 25 mcg, 50 mcg, 75 mcg, and 100 mcg doses. The recalled injections were distributed throughout the United States to healthcare facilities and pharmacies.
The recall may pose a significant challenge for patients and prescribing doctors, as Natpara is currently the only medication in the US approved for adjunctive treatment of adult patients with chronic hypoparathyroidism which cannot be adequately controlled with standard therapy alone (calcium and vitamin D).
Takeda recommends patients consult with their prescribing doctors for an alternative treatment before stopping Natpara, as a sudden stop in treatment may cause a sudden drop in blood calcium levels.
According to Takeda, it is critically important patients contact their prescribing healthcare provider 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 hypocalcemia.
Takeda announced the company is working with the U.S. Food and Drug Administration (FDA) to resolve the issue and resume supply to patients as soon as possible. Healthcare providers with questions or concerns about the Natpara recall are encouraged to contact Takeda Medical Information at 1-800-828-2088 for additional information.