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 ceftriaxone has been updated to include a warning about encephalopathy, particularly in older patients with underlying renal impairment or central nervous system disorders. Hepatitis has also been listed as a potential adverse event of ceftriaxone, along with encephalopathy.
Ceftriaxone (also known as ceftriaxone sodium) is a broad-spectrum cephalosporin antibiotic used in adults and children. It is approved for the treatment of pneumonia, skin infections, urinary tract infection, gonorrhoea, septicaemia, meningitis, bone and joint infections. It is also used for surgical prophylaxis.
Warnings about encephalopathy and hepatitis have been added to the ceftriaxone PI based on evidence published in the literature and from post-market adverse event data in Australia and internationally.[1],[2]
The following warning has been added to section 4.4 of the PI 'Encephalopathy has been reported with the use of ceftriaxone, particularly in elderly patients with severe renal impairment or central nervous system disorders. If ceftriaxone-associated encephalopathy is suspected (e.g. decreased level of consciousness, altered mental state, myoclonus, convulsions), discontinuation of ceftriaxone should be considered.'
'Hepatitis and hepatic cholestatic (frequency unknown)' and 'encephalopathy (rare)' have been added to section 4.8 of the PI as potential adverse effects.
Adverse events reported to the TGA
To 16 November 2021, we have received 38 reports of hepatitis, 10 of cholestatic hepatitis, 3 of hepatomegaly and one of hepatocellular injury, all suspected to be related to ceftriaxone.
We have also received 3 reports of encephalopathy for ceftriaxone. Two of these cases are described in a study reviewing case reports of patients with cephalosporin-related neurotoxicity in Western Australia.[1]
These reports are included in our Database of Adverse Event Notifications (DAEN).
Information for health professionals
These adverse events can have serious consequences for patients, and it is important that prescribers are aware of the risks.
Encephalopathy has been reported particularly in the elderly with severe renal impairment or central nervous system disorders. If you suspect encephalopathy, consider stopping the medicine.
See the latest PI documents for ceftriaxone products - external site for further information.
References
| [1] | Triplett JD, Lawn ND, Chan J and Dunne JW. Cephalosporin-related neurotoxicity: Metabolic encephalopathy or non-convulsive status epilepticus? - external site J Clin Neuroscience. 2019;67:163-66. https://doi.org/10.1016/j.jocn.2019.05.035 - external site |
|---|---|
| [2] | Boyd I. Ceftriaxone and hepatitis in patients 75 years and older - external site. WHO Pharmaceuticals Newsletter 2018;6:24-30 |
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
This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to tga.copyright@tga.gov.au.
For the latest safety information from the TGA, subscribe to the TGA Safety Information email list via the TGA website.
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 Jovi van der Kallen and Ms Rebecca Page