Our investigation into the risk of heart attack 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). The PI and CMI now also advise that patients with a history of heart attack or stroke should not take romosozumab.
Both documents have been updated with additional warnings to reflect the risks.
Romosozumab is used to treat:
- osteoporosis in postmenopausal women
- for treatment to increase bone mass in men with osteoporosis.
Heart attack and stroke are serious life-threatening conditions that require prompt diagnosis and management. The new warnings highlight the risks of developing these conditions, which can be fatal, as well as pre-existing patient risk factors that may make the medicine unsuitable for them.
We consider that the benefit-risk balance of romosozumab remains positive, and it continues to be a useful treatment for osteoporosis for some patients.
What patients should do
If you or someone you care for are taking romosozumab and you are concerned about this issue, contact your prescribing doctor to discuss the benefits and risks of the medicine.
You should also familiarise yourself with the updated CMI.
Speak to your doctor if you are taking romosozumab and have a history of heart attack or stroke.
Your doctor can also advise on any signs to look out for relating to heart attack and stroke.
What health professionals should do
Be alert to the updated warnings in the PI and discuss the benefit-risk balance with your patients who are taking romosozumab.
For more detailed information written for health professionals, including the full text of the additional warnings, see this Medicine Safety Update article.