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FDA approved new indication for teriparatide to treat osteoporosis
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The FDA has approved a new use for teriparatide injection to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture.
Gloucocorticoid medications are the most common cause of secondary osteoporosis and are commonly used in patients with inflammatory conditions such as rheumatoid arthritis and obstructive pulmonary disease.
The FDA approved teriparatide (Forteo, Lilly) in 2002 for the treatment of osteoporosis in postmenopausal women and men with primary or hypogonadal osteoporosis at high risk for fracture. Since then, more than 3 million prescriptions have been filled in the United States.
The FDA reviewed a clinical study that demonstrated teriparatide injection increased bone mineral density in patients with glucocorticoid-induced osteoporosis during 18 months by 7.2% at the lumbar spine, 3.7% at the femoral neck and 3.6% at the total hip.
Teriparatide also includes updated language in the existing boxed warning section of the label regarding the risk for osteosarcoma to reinforce that the drug should not be used in pediatric and young adults.
Lilly has also established a voluntary Forteo Patient Registry to further evaluate the long-term safety of teriparatide. For more information, visit the Forteo website.