Other safety alerts
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| Australia: New warnings of romosozumab (Evenity) cardiovascular risks |
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Therapeutic Goods Administration (TGA) announces 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 Information (CMI). Romosozumab use is now also contraindicated in patients with a history of myocardial infarction or stroke.
TGA undertook a signal investigation in Oct 2023 to assess the risk of myocardial infarction and stroke with romosozumab.
Myocardial infarction and stroke are serious life-threatening conditions that require prompt diagnosis and management. They can both result in death, permanent disability and significant hospital stays.
The Australian, European Union and United States product information documents all describe the results of 2 pivotal studies providing data about the potential risk of major adverse cardiac events associated with romosozumab. There was a higher rate of major adverse cardiac events (a composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke) associated with romosozumab in one trial but not the other. The disparity between these 2 trials has been a focus for regulators assessing the safety of this medicine.
TGA considers that the benefit-risk balance of romosozumab remains positive, and it continues to be a useful treatment for osteoporosis for some patients.
The following sections of the PI and CMI have been updated to reflect an increased risk of myocardial infarction and stroke: Contraindications; Special warning and precautions for use; and Adverse events.
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.
A search of TGA’s Database of Adverse Event Notifications on 27 Nov 2023 identified 9 related distinct case reports (some including multiple adverse events): intraventricular haemorrhage (2), cerebrovascular accident (2), acute myocardial infarction (1), cerebral haemorrhage (1), embolic stroke (1), myocardial infarction (2), transient ischaemic attack (1). The outcomes of the reported adverse events were all serious with 2 leading to death.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/news/safety-updates/new-warnings-romosozumab-evenity-cardiovascular-risks
In Hong Kong, there is one registered pharmaceutical product containing romosozumab, namely Evenity Solution For Injection in Prefilled Syringe 105mg/1.17ml (HK-66741). The product is registered by Amgen Hong Kong Limited. It is a prescription-only medicine. So far, the Department of Health (DH) has received 2 cases of adverse drug reaction related to romosozumab, but these cases were not related to myocardial infarction or stroke. The current product information of the locally registered Evenity product includes safety information on the risk of myocardial infarction and stroke, and the product is contraindicated in patients with a history of myocardial infarction or stroke. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Thursday, Dec 7, 2023
Issued at HKT 16:00
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