In the wake of the recall of hypoparathyroidism drug NATPARA, the drug’s manufacturer, Takeda, is working with the FDA to develop a Special Use Program.
The program is intended to support patients previously prescribed NATPARA who are facing life-threatening complications as a result of discontinuation of NATPARA.
Through this program, healthcare providers will be able to request NATPARA for these extraordinary, life-threatening cases. It is anticipated that an extremely small number of patients prescribed NATPARA will qualify for this very limited program. Additional information for healthcare providers about the Special Use Program can be found here. Patients who have questions about their eligibility under the Special Use Program or about their individual treatment plans should consult with their healthcare providers.
In a release, Takeda stated that while this program is an important first step, it will only help a very small number of patients. “We recognize that many more patients are in need of NATPARA to control their hypoparathyroidism. Takeda continues to work with the FDA on both short- and long-term solutions to bring NATPARA back to the broader patient community, which remains our highest priority,” according to the statement.
“We are committed to the hypoparathyroidism community and the safe supply of NATPARA. We will continue to work urgently on this issue and keep patients and healthcare providers informed of our progress in resuming supply,” the statement adds.
On September 18, the Endocrine Society issued a joint statement with the American Society for Bone Mineral Research (ASBMR) to assist healthcare providers who may be treating patients prescribed NATPARA.