Summary
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.
