Our investigation into the risk of myocardial infarction and stroke in patients taking romosozumab (Evenity) found that stronger warnings regarding these risks were needed in the Product Information (PI) and Consumer Medicine Information (CMI). Romosozumab use is now also contraindicated in patients with a history of myocardial infarction or stroke.

The following sections of these documents have been updated to reflect an increased risk of myocardial infarction and stroke: Contraindications; Special warning and precautions for use; and Adverse events.

What health professionals should do

Health professionals should be alert to the updated warnings and new contraindications and should inform patients and carers of the potential cardiovascular risks associated with romosozumab use.

See the full article on the TGA website.

Reproduced with permission from Therapeutic Goods Administration (TGA) Medicines Safety Update 7 December 2023.