Romosozumab carries a black box warning for increased risk of what type of events?

• A. No risk of events
• B. Increased cardiovascular events
• C. Renal toxicity
• D. Liver injury

Answer: (B)

Romosozumab has a black box warning because it is associated with an increased risk of cardiovascular events, specifically major adverse cardiovascular events such as heart attack and stroke. This safety signal from clinical trials led regulators to limit its use to patients at very high fracture risk who cannot use other osteoporosis therapies, and to avoid use in those with recent cardiovascular events (for example, within the past year). After completing romosozumab, patients are typically transitioned to an antiresorptive agent to maintain bone density. The warning is about cardiovascular risk, not renal or liver injury.