From the Guidelines
Evenity (Romosozumab) is associated with an increased risk of myocardial infarction, stroke, and death.
Side Effects of Evenity (Romosozumab)
- The medication may increase the risk of cardiovascular events, including myocardial infarction and stroke, as compared to other osteoporosis treatments like alendronate 1.
- Atypical femur fractures and osteonecrosis of the jaw are potential risks associated with Romosozumab, similar to other anti-resorptive agents like bisphosphonates and denosumab 1.
- The anabolic effect of Romosozumab wanes after 12 monthly doses, and its use should be limited to this duration 1.
- There is moderate-certainty evidence that Romosozumab reduces clinical vertebral fractures, radiographic vertebral fractures, and any clinical fractures compared to placebo, but its effect on hip fractures is not reported 1.
- The FDA has issued safety warnings recommending against the use of Romosozumab in patients with a high risk for major cardiovascular events 1.
Clinical Considerations
- Romosozumab is conditionally recommended for patients who are intolerant of other osteoporosis medications, due to its potential benefits in increasing bone mass and reducing fracture risk 1.
- However, its use should be carefully considered in patients with a history of cardiovascular disease or those at high risk for cardiovascular events, due to the potential increased risk of myocardial infarction, stroke, and death 1.
From the FDA Drug Label
EVENITY can cause serious side effects, including: increased risk of having a heart attack, stroke, or death from a cardiovascular (heart or blood vessel) problem EVENITY may cause serious side effects, including: Serious allergic reactions. Low calcium levels in your blood (hypocalcemia). Severe jaw bone problems (osteonecrosis).
The side effects of Evenity (Romosozumab) include:
- Increased risk of heart attack, stroke, or death from a cardiovascular problem
- Serious allergic reactions
- Low calcium levels in the blood (hypocalcemia)
- Severe jaw bone problems (osteonecrosis) 2
From the Research
Side Effects of Evenity (Romosozumab)
The side effects of Evenity (Romosozumab) include:
- Cardiovascular events, which is a primary safety concern 3, 4, 5
- Hypersensitivity and injection site reactions, with reactions occurring in about 5% of patients at the puncture site 6, 4, 5
- Hypocalcemia, which must be corrected prior to initiation of romosozumab 3
- Arthralgia and headache, which are other adverse effects observed in clinical trials 5
- Increased risk of major adverse cardiac events, which was observed in one clinical trial 5
Common Adverse Events
Common adverse events associated with romosozumab include:
- Injection site reactions, which are more common with romosozumab compared to other osteoporosis treatments 6
- Hypersensitivity reactions, which are also more common with romosozumab compared to other treatments 6
- Cardiovascular events, which are a concern due to the potential risk of major adverse cardiac events 3, 4, 5
Special Considerations
Special considerations for the use of romosozumab include: