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Ceftriaxone and risk of hepatitis and encephalopathy
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.,
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.
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 for further information.
|||Triplett JD, Lawn ND, Chan J and Dunne JW. Cephalosporin-related neurotoxicity: Metabolic encephalopathy or non-convulsive status epilepticus? J Clin Neuroscience. 2019;67:163-66. https://doi.org/10.1016/j.jocn.2019.05.035|
|||Boyd I. Ceftriaxone and hepatitis in patients 75 years and older. 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:
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