Why was NATPARA recalled?

Why was NATPARA recalled?

In 2019, the company recalled all U.S. Natpara doses over fears that particulates from the rubber covering, or septum, of the injector cartridge could shed into the injectors.

Has NATPARA been recalled?

After discussions with the FDA, Takeda issued a US recall on September 5, 2019, for all doses of NATPARA® (parathyroid hormone) for Injection (25 mcg, 50 mcg, 75 mcg, and 100 mcg).

What happened to NATPARA?

NATPARA was voluntarily pulled off the market by the manufacturer (Takeda) after small particles of rubber were found in some samples of the solution as a result of the reusable injection system.

Who owns NATPARA?

NATPARA.com (the “website”) is owned and operated by Shire Human Genetic Therapies Inc., 300 Shire Way, Lexington, MA 02421 (“Shire Human Genetic Therapies”).

When will NATPARA be available?

Takeda announced a need for more modifications and testing in addressing capsule problems than initially anticipated in January 2020, affecting its timeline for reintroducing Natpara to U.S. patients. A restoration of treatment availability was reported to be pushed back at least to March 2021.

What is NATPARA used for?

NATPARA is a prescription parathyroid hormone used with calcium and vitamin D to control low blood calcium (hypocalcemia) in adults with low parathyroid hormone (PTH) blood levels (hypoparathyroidism).

Can Forteo be used for hypoparathyroidism?

Parathyroid hormone (PTH) 1-34 replacement therapy with teriparatide (Forteo, Eli Lilly) may represent a valuable tool to manage mental and physical health in chronic postsurgical hypoparathyroidism, according to the largest study of its kind.

How is NATPARA administered?

NATPARA is a self-administered, once-daily, subcutaneous injection into alternating thighs. The goal of NATPARA treatment is to achieve serum calcium within the lower half of the normal range.

What are the symptoms of hypoparathyroidism?

The symptoms of hypoparathyroidism can include:

• a tingling sensation (paraesthesia) in your fingertips, toes and lips.
• twitching facial muscles.
• muscle pains or cramps, particularly in your legs, feet or tummy.
• tiredness.
• mood changes, such as feeling irritable, anxious or depressed.
• dry, rough skin.

What is the most common cause of hypoparathyroidism?

The most common cause of hypoparathyroidism is removal of or accidental injury to the parathyroid glands during surgery to the neck.

What happens when you have hypoparathyroidism?

Signs and symptoms of hypoparathyroidism can include: Tingling or burning in your fingertips, toes and lips. Muscle aches or cramps in your legs, feet, stomach or face. Twitching or spasms of your muscles, particularly around your mouth, but also in your hands, arms and throat.

What are the 4 clinical manifestations of hypoparathyroidism?

Signs and symptoms of hypoparathyroidism can include:

• Tingling or burning in your fingertips, toes and lips.
• Muscle aches or cramps in your legs, feet, stomach or face.
• Twitching or spasms of your muscles, particularly around your mouth, but also in your hands, arms and throat.
• Fatigue or weakness.
• Painful menstrual periods.

How is Natpara used in the United States?

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).

Is the Natpara recombinant human protein still available?

NATPAR/A continues to be available in these markets. 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

How is Natpara used to treat hypocalcemia?

NATPARA is a prescription parathyroid hormone used with calcium and vitamin D to control low blood calcium (hypocalcemia) in people with low parathyroid hormone blood levels (hypoparathyroidism). It is only for people who do not respond well to treatment with calcium and active forms of vitamin D alone, because it may increase the possible risk…

How is Natpara used to treat hypoparathyroidism?

NATPARA is a prescription parathyroid hormone used with calcium and vitamin D to control low blood calcium (hypocalcemia) in people with low parathyroid hormone blood levels (hypoparathyroidism).