Medication recommended for use in patients for whom the potential benefits outweigh potential risk
MONDAY, Jan. 26, 2015 (HealthDay News) — Natpara (parathyroid hormone) has been approved by the U.S. Food and Drug Administration to control hypocalcemia among people with hypoparathyroidism.
Natpara, a once-daily injection, was evaluated in a clinical study of 124 people. Forty-two percent of those treated with Natpara achieved normal blood calcium levels, the FDA said. The most common side effects included paraesthesia, low blood calcium, headache, high blood calcium, and nausea.
The drug’s label includes a boxed warning that osteosarcoma had been observed in a study of rats given Natpara. However, it is unknown if the drug would cause osteosarcoma among people, the FDA said. As a result, Natpara is only recommended for use in patients for whom the potential benefits outweigh this potential risk.
“People with hypoparathyroidism have limited treatment options and face challenging symptoms that can severely impact their quality of life,” Jean-Marc Guettier, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “This product offers an alternative to patients whose calcium levels cannot be controlled on calcium supplementation and active forms of vitamin D.”
Natpara is produced by NPS Pharmaceuticals, based in Bedminster, N.J.