FDA approved once-daily subcutaneous injectable recombinant parathyroid-hormone (PTH) product (Natpara) as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism on 23 jan 2015.Patients with hypoparathyroidism can experience numbness, tingling, muscle twitching, spasms or cramps, abnormal heart rhythm, and seizures as a consequence of low blood calcium levels. Hypoparathyroidism is also associated with long-term complications such as renal damage, kidney stones, development of cataracts, and calcification of soft tissues. One of the concerns is a potential risk for osteosarcoma, because an agent similar to Natpara approved for osteoporosis (Forteo , Eli Lilly) has been associated with a higher risk for this adverse effect and osteosarcoma has been observed in rat studies with Natpara. It is unknown whether Natpara causes osteosarcoma in humans, but because of this potential risk, it is recommended only for patients who cannot be well-controlled on calcium supplements and active forms of vitamin D alone. The starting dose of Natpara is 50 μg once daily, and it will be available only through a Risk Evaluation and Mitigation Strategy (REMS) and will contain a boxed warning citing the potential risk for osteosarcoma. The most common side effects observed in Natpara-treated participants were sensations of tingling, tickling, pricking, or burning of the skin (paresthesia); low blood calcium; headache; high blood calcium; and nausea. fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm431358.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
Posted on: Tue, 27 Jan 2015 11:54:11 +0000
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