The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Health professionals are advised that the Product Information (PI) for erenumab has been updated with a warning statement about a potential causal relationship between the drug and hypertension.
Erenumab is indicated for prophylaxis of migraine in adults. It is marketed in Australia under the brand name Aimovig.
The ‘Special Warnings and Precautions’ section (Section 4.4) of the PI for erenumab has been updated to state that development of hypertension and worsening of pre-existing hypertension have been reported following use of the drug in the postmarketing setting internationally. Many of the affected patients had pre-existing hypertension or risk factors for hypertension. There were cases requiring pharmacological treatment and, in some cases, hospitalisation.
Hypertension can occur at any time during treatment, but it was most frequently reported within 7 days of dose administration. In the majority of cases, the onset or worsening of hypertension was reported after the first dose of erenumab. The drug was discontinued in many of the reported cases. There has been one report of hypertension associated with erenumab reported in Australia, to the TGA.
Additionally, hypertension has been added under ‘Vascular disorders’ in the ‘Adverse Effects’ section (Section 4.8) of the erenumab PI.
Information for health professionals
If you are treating a patient with erenumab, you should monitor them for new-onset hypertension or worsening of pre-existing hypertension.
If hypertension is observed and evaluation fails to establish an alternative etiology, consider whether discontinuation of erenumab is warranted.
Further reading
Saely S, Croteau D, Jawidzik L, Brinker A, Kortepeter C. Hypertension: A new safety risk for patients treated with erenumab. Headache. 2021;61:202-208.
What to report? You don't need to be certain, just suspicious!
The TGA encourages the reporting of all suspected adverse reactions to medicines, including vaccines, over-the-counter medicines, herbal, traditional or alternative remedies.
We particularly request reports of:
- all suspected reactions to new medicines (look for the Black Triangle in PI and CMI documents - this symbol identifies medicines that are new or being used differently)
- all suspected medicines interactions
- suspected reactions causing death, admission to hospital or prolongation of hospitalisation, increased investigations or treatment, or birth defects.
Reports may be submitted:
- online at www.tga.gov.au
- by fax to 02 6232 8392
- by email to ADR.Reports@tga.gov.au
For more information about reporting, visit www.tga.gov.au or contact the TGA's Pharmacovigilance and Special Access Branch ADR.Reports@tga.gov.au.
Disclaimer
Medicines Safety Update is aimed at health professionals. It is intended to provide practical information to health professionals on medicine safety, including emerging safety issues. The information in Medicines Safety Update is necessarily general and is not intended to be a substitute for a health professional's judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information is accurate and complete at the time of publication. The Australian Government gives no warranty that the information in this document is accurate or complete, and shall not be liable for any loss whatsoever due to negligence or otherwise arising from the use of or reliance on this document.
© Commonwealth of Australia 2021
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For correspondence or further information about Medicines Safety Update, contact the TGA's Pharmacovigilance and Special Access Branch at ADR.Reports@tga.gov.au.
Medicines Safety Update is written by staff from the Pharmacovigilance and Special Access Branch.
Editor: Dr Catherine Brogan
Deputy Editor: Mr Michael Pittman
Contributor: Ms Rebecca Page and Mr Gilbert Yeap