FDA Approves Osteoporosis Drug for Postmenopausal Women, Warns About Heart Risks

By Kaitlyn D’Onofrio - Last Updated: April 12, 2019

The Food and Drug Administration (FDA) this week announced its approval for romosozumab-aqqg (Evenity) to treat osteoporosis in postmenopausal women at high risk for fracture. The medication comes with a boxed warning for possible increased risk of heart attack, stroke, and cardiovascular death. 

“Today’s approval provides women with postmenopausal osteoporosis who are at high risk of fracture with a new treatment that will reduce this risk,” said Hylton V. Joffe, mDMMSc., director of the Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products, in a statement. “But 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.” 

Romosozumab-aqqg was tested in two clinical trials that included a total of more than 11,000 women with postmenopausal osteoporosis. The first trial compared one-year efficacy of romosozumab-aqqg to placebo and found that it reduced the risk of new vertebral fracture by 73% compared to placebo; this continued over the second year as well when the medication was followed by a year of denosumab—another osteoporosis therapy—compared to placebo followed by denosumab. The second trial compared romosozumab-aqqg to alendronate—another osteoporosis therapy—and found that one year of romosozumab-aqqg reduced new vertebral fracture risk by 50% compared to two years of alendronate. It was in this trial—not the placebo trial—where an increased risk was observed for cardiovascular death, heart attack, and stroke. Romosozumab-aqqg is therefore not indicated for patients who have had a heart attack or stroke within the previous year. 

Health care professionals should also consider whether the benefits of Evenity outweigh its risks in those with other risk factors for heart disease and should discontinue Evenity in any patient who experiences a heart attack or stroke during treatment,” according to the FDA. Side effects associated with romosozumab-aqqg included joint pain, headache, and injection site reactions, the FDA noted.  

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