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News From the Food and Drug Administration
May 21, 2019

Caution With New Osteoporosis Drug

JAMA. 2019;321(19):1862. doi:10.1001/jama.2019.6189

Postmenopausal women with osteoporosis who are at high risk of bone fractures have a new treatment option. The recently approved monoclonal antibody therapy romosozumab promotes new bone growth and decreases bone resorption by blocking the protein sclerostin, which inhibits bone formation.

Marketed as Evenity, the drug comes with a boxed warning regarding serious risks that clinicians should consider when making treatment recommendations. “Evenity may increase the risk of heart attack, stroke and cardiovascular death so it’s important to carefully select patients for this therapy, which includes avoiding use in patients who have had a heart attack or stroke within the previous year,” Hylton V. Joffe, MD, MMSc, director of the FDA’s Division of Bone, Reproductive and Urologic Products, explained in a statement.