New TGA warnings of romosozumab (Evenity) cardiovascular risks

8 December 2023

Australian regulator the Therapeutic Goods Administration (TGA) says that its 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 (CMI) Information external sites.

Marketed globally by Belgium’s UCB (Euronext: UCB) and US biotech Amgen (Nasdaq: AMGN), in Australia, 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.

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